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Using a qualitative sub-study to inform the design and delivery of randomised controlled trials on medicinal cannabis for symptom relief in patients with advanced cancer

Trials volume 23, Article number: 752 (2022) Cite this article

Abstract

Background

Recruitment for randomised controlled trials in palliative care can be challenging; disease progression and terminal illness underpin high rates of attrition. Research into participant decision-making in medicinal cannabis randomised controlled trials (RCTs) is very limited. Nesting qualitative sub-studies within RCTs can identify further challenges to participation, informing revisions to study designs and recruitment practices. This paper reports on findings from a qualitative sub-study supporting RCTs of medicinal cannabis for symptom burden relief in patients with advanced cancer in one Australian city.

Methods

Semi-structured qualitative interviews were conducted with 48 patients with advanced cancer, eligible to participate in a medicinal cannabis RCT (n=28 who consented to participate in an RCT; n=20 who declined). An iterative and abductive approach to thematic analysis and data collection fostered exploration of barriers and enablers to participation.

Results

Key enablers included participants’ enthusiasm and expectations of medicinal cannabis as beneficial (to themselves and future patients) for symptom management, especially after exhausting currently approved options, and a safer alternative to opioids. Some believed medicinal cannabis to have anti-cancer effects. Barriers to participation were the logistical challenges of participating (especially due to driving restrictions and fatigue), reluctance to interfere with an existing care plan, cost, and concerns about receiving the placebo and the uncertainty of the benefit. Some declined due to concerns about side-effects or a desire to continue accessing cannabis independent of the study.

Conclusions

The findings support revisions to subsequent medicinal cannabis RCT study designs, namely, omitting a requirement that participants attend weekly hospital appointments. These findings highlight the value of embedding qualitative sub-studies into RCTs. While some challenges to RCT recruitment are universal, others are context (population, intervention, location) specific. A barrier to participation found in research conducted elsewhere—stigma—was not identified in the current study. Thus, findings have important implications for those undertaking RCTs in the rapidly developing context of medical cannabis.

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Background

Maximising recruitment and minimising attrition are both important for drawing valid conclusions from randomised controlled trials (RCTs) [1]. An estimated 50% of RCTs fail to meet recruitment targets [2]. Poor recruitment prolongs study timelines and increases costs [3, 4]. These setbacks are particularly problematic in palliative medicine clinical trials, which tend to have higher rates of attrition [5].

Key challenges to RCT recruitment identified by systematic reviews include overestimation of eligible participants, poor trial communication and understanding, perceived burden for participants and recruiting clinicians, prejudice related to trial effectiveness, and influence from trusted others on patient decision-making [6,7,8]. As personal benefit along with benefit to others is key deciding factors, increasing awareness of the health problem, the possible benefits of the intervention being trialled, and engaging eligible participants in the trial process are common strategies for improving recruitment [7, 9,10,11]. Furthermore, given their centrality to trial communication, training recruiters is another strategy for improving trial recruitment [12].

Although some of these challenges are common to all RCTs, specific trials can also have their own unique challenges [13, 14]. Recruiting patients with advanced cancer within palliative care, for instance, poses significant and distinct challenges. Three central barriers to recruitment have been raised [5]: (1) concern for the patient’s health and future (e.g. frailty, uncertain prognosis); (2) gatekeeping—clinicians and informal carers shielding a patient from the false hope or burden of a clinical trial; and (3) ethical concerns about clinical equipoise, vulnerability, and capacity to consent. As a consequence, older and/or palliative care patients tend to be under-represented in clinical trials more generally [15,16,17,18,19], despite research showing many of these patients’ and family members’ desire to participate in RCTs [20].

Despite these challenges, there has been developing interest in clinical trials involving medicinal cannabis and consideration of its potential use in older patient populations and palliative care contexts [21,22,23,24,25,26]. Although most Australians approve of medical cannabis clinical trials and medicinal cannabis use in oncology [27, 28], given the history of cannabis as an illicit substance, this may not translate to direct interest in RCT participation. Available research from North America, Israel, and Europe found stigma, risk, and access pathways to be primary concerns around medical cannabis [29,30,31,32,33,34,35,36]. Research in the Australian setting, a unique social, regulatory, and clinical context, is sparse [37]. Where it exists, studies are largely survey-based, assessing general attitudes to medicinal cannabis [22, 38,39,40,41]. Research into patients’ perceptions of medicinal cannabis and trial participation decision-making is even more limited—in large part because clinical trials of medicinal cannabis in Australia have only recently emerged in significant numbers [42, 43]. Available studies show few Australian participants hold concerns related to adverse effects; a minority believe cannabis might cure cancer [40, 41, 43, 44]. Overall, however, little is known about Australian patients’ perceptions of medicinal cannabis and even less is known about enablers and barriers to recruiting patients with advanced cancer to medicinal cannabis RCTs [26, 35].

International guidelines advocate for the use of qualitative sub-studies within RCTs to identify and address recruitment challenges, specific to local contexts and cultures [45,46,47]. Qualitative research can improve the potential viability and depth of RCT findings [13, 48]. Moreover, qualitative sub-studies can provide insight into in situ barriers and enablers to participation specific to the intervention, population and setting [13, 14], including those related to study design (e.g. eligibility, participation requirements), participants (e.g. willingness, language and communication needs), practitioners (e.g. clinical and research role imbalances), ethics (e.g. privacy, risk to individual patients), practice (e.g. space, staffing), collaboration (e.g. interprofessional engagement, co-location of research and clinical staff) and health systems (e.g. policies) [49, 50].

This paper reports findings from a qualitative sub-study nested within medicinal cannabis trials for symptom burden relief in patients with advanced cancer. The primary aim was to identify enablers and barriers to recruitment and participation from patients’ perspectives, informing the refinement of current and future RCTs.

Trial context

Following 2016 legislation permitting limited access to cannabis for research and medicinal purposes in Australia [51], a pilot study (MedCan Pilot) [52], followed by MedCan 1 [42] and 2 [53], was established to generate an evidence-base for cannabis use in palliative care [43, 54,55,56]. Patients eligible for inclusion had advanced cancer (metastatic or locally advanced) with associated symptom burden as measured by an Edmonton Symptom Assessment Scale (ESAS) total symptom distress score (TSDS) of ≥10 for cancer-related symptoms and at least one individual ESAS score ≥3. All participants were required to abstain from consuming other cannabis products and, for MedCan Pilot and MedCan 2, refrain from driving while on the trial. Those consenting to be part of the study continued to receive standard palliative care (see Table 1 and published protocols).

Table 1 MedCan study details
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Methods

Study design

Anticipating recruitment challenges [2, 5], a nested qualitative sub-study (TalkingMedCan) was undertaken in 2019–2020 with patients who had either met eligibility criteria to participate in MedCan Pilot, 1 or 2 (MedCan) and enrolled to participate in a trial, or who were eligible to participate but declined. Semi-structured interviews were selected for data collection for their capacity to offer inductive insight, while accommodating the time and communication needs of patients with advanced cancer [57, 58]. Ethical approval for TalkingMedCan was obtained from the Human Research Ethics Committees at the hospitals providing care (HREC/17/MHS/97;HREC 17/27).

Sampling and recruitment

A purposive strategy was adopted to gain a balanced sample based on gender, age and diagnosis and to obtain maximum variation. Recruitment was led by trial investigators and research nurses who would identify eligible patients. A copy of the participant information sheet and consent form was provided, facilitating a verbal discussion with the patient on the risks and benefits of participation. Once a patient agreed to participate and provide written consent, the clinical trial coordinator liaised with the patient and research team to arrange a suitable time and place for the interview.

Participants

Forty-eight patients with advanced cancer undertook semi-structured interviews for TalkingMedCan (n=28 who consented to participate in a trial and n=20 who declined). Of those who consented, most were participating in MedCan1 (n=2 MedCan Pilot, n=23 MedCan1, n=3 MedCan2). Aiming for sampling variation, the most common primary cancer diagnoses were breast, prostate and lung (Table 2); others included bladder, bile duct, colorectal, endometrial, gastro-oesophageal, glioma, kidney, mesothelioma, ovarian, pancreatic, rectal and urothelial. The majority of participants were receiving anticancer therapy. Only 8 (17%) of the 48 patients interviewed reported no comorbidities.

Table 2 Demographic characteristics of interview participants
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Most participants were aged >50 years and identified as female of Anglo-Saxon or English ethnicity. Some identified as Australian or Pacific Islander. Twelve/23 male participants, and 16/25 female participants had enrolled in a clinical trial at the time of interview; 9/25 female participants and 11/23 male participants declined trial participation. Forty-one participants were living in a household with others (most commonly their spouse only, n=26). All but 8 participants reported secondary school as their highest level of education.

Semi-structured interviews

All interviews—lasting between 20 and 60 min—were facilitated by a member of the research team not involved in patient care with interviewing experience and recorded using a digital voice recorder before being transcribed verbatim. Most interviews were conducted in a private hospital consultation room, directly following an appointment at the hospital (n=42). After the onset of COVID-19, and in accordance with an approved ethics amendment, six interviews were conducted via telephone. Family/support members were permitted to be present in interviews. Several accepted this invitation, but any verbal contributions to interviews were omitted from final analysis. Interview questions were designed to foster in-depth exploration of patients’ perceptions of medicinal cannabis, and of barriers and enablers to participation in MedCan trials (Table 3). Aligned with iterative approaches to data collection, data generated in earlier interviews informed refinements to the semi-structured interview guide (e.g. prompts regarding financial and transport considerations). This iterative approach also enabled identification of data saturation during analysis [44, 59].

Table 3 Interview guide
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Data analysis

Transcripts were analysed thematically and, by case, prompting us to consider patterns across and the context within the data, and guided by inductive and iterative approaches to interpretivist thematic analysis and constructivist grounded theory [60, 61]. Analysis was led by an experienced qualitative health researcher, with advanced training in the social sciences. Triangulation, including multiple team members with backgrounds in sociology, anthropology and medicine, involved three team members (RO, PG, TD) closely reading five transcripts and discussing themes prior to formal coding, and then three team members (AS, RO, MD) reviewing data displays and coding frameworks in the latter stages of analysis. This fostered insight into study implications and their relevance to differing audiences. NVivo 12 qualitative analysis software—with files saved to a password-protected data management platform—was used to support data management, and to create and organise codes based on the research aims, interview questions, and emerging findings. Participant details (e.g. name, address) were stored in a separate location to transcripts and NVivo files to prevent unnecessary cross-referencing. Inductive, deductive and abductive techniques were employed [61,62,63]. Open coding was undertaken to identify new themes and facilitate cross-data source comparison. In the latter stages, themes were mapped against the literature [7, 49].

Recruitment and analysis ended at the point of theoretical saturation, when no new themes were seen to emerge and data was sufficient for pattern recognition across purposively sampled groups [59]. This paper describes and explores the interrelated key themes of enablers and barriers to trial participation, from patients’ perspectives. Other findings on participants’ perceptions of medicinal cannabis are reported elsewhere [64].

Results

In this section, we present findings of why interviewees accepted or declined invitations to participate in MedCan using summary tables. De-identified quotes are presented with reference to each interviewee’s participant number, gender (F/M) and decision regarding RCT participation. Aligned with constructivist approaches to thematic analysis [60, 62], we explicitly reference scholarship informing deductive elements of analysis, highlighting which findings are novel to the intervention, context and population.

Enablers of trial participation

Despite some of the widely reported challenges to recruitment in RCTs generally, and within palliative care contexts more specifically [5], interest in participating in the MedCan trials (Pilot, MedCan1, MedCan2) was strong. Illustrating the enthusiasm for the study, one interviewee described their interest as ‘a little bit of altruism… a lot of curiosity’ (P30M, declined). Others, after hearing ‘so many good things that are happening with it [medicinal cannabis]’ (P10F, agreed), wanted to ‘give it a go’ (P21F, agreed), saying ‘Let me try it’ (P7M, agreed).

Key enablers to trial participation are shown in Tables 4, 5, 6, and 7 aligned with previous research showing perceived benefits to self and others to be central [7, 9, 11]. Anticipated benefits, however, were often specific to medicinal cannabis. Possible self-benefits encompassed specific symptom control, generalised wellbeing and a sense of doing everything in one’s capacity to manage one’s quality of life, a belief (however indirect) in cannabis’s curative potential and a hope for viable and more ‘natural’ alternatives to current or previous medications. Perceived potential benefits to others from participation were wide ranging: contributions to knowledge, possible cure for cancer, and political efforts to legalise cannabis.

Table 4 Enablers: perceived benefits to self, I
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Table 5 Enablers: perceived benefits to self, II
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Table 6 Enablers: perceived benefits to self, III
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Table 7 Enablers: perceived benefits to others
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Perceived benefits to self

Symptom burden relief and general wellbeing

Many patients spoke of their experiences of pain and anticipation of further pain, both treatment- and disease-related, as well as pain related to comorbid conditions. Potential benefit to nausea and appetite was another common perceived benefit. Patients were explicit in wanting ‘to try anything’ (P2F, agreed; P13F, agreed; P16M, agreed; see Table 4 Sub-theme ‘exhausting all options’) to address symptoms and side-effects: ‘grasping at straws… to see if it eases my way forward’ (P4F, agreed). For others, interest in participating in MedCan was propelled by expectations of ameliorated capacity, and improved wellbeing through better physical and emotional functioning, such as an ability to ‘walk….play golf’ (P22M, agreed) or a generalised improved ‘coping’ capacity (P23F, agreed; see Table 4 Theme ‘Improved general wellbeing’).

Belief in anti-cancer effect

Some patients were partially motivated by perceived anti-cancer effects. For these participants, discussions of exhausting all options for symptom relief and exhausting all options for treating disease progression blurred together, raising questions about participants’ understanding of the trial’s purpose. Interviewee P10F (agreed), for example, described her ‘hope it can help me, my cancer. Or at least how I deal with it’ (see Table 5, Sub-theme ‘Alluded hope’). Other participants more candidly indicated a belief in the anti-cancer effect of medicinal cannabis, often alongside acknowledgement and comprehension that the clinical trial was not designed with this in mind. Interviewee P6F (agreed), for instance, stated, ‘I'm told it won't help the cancer, but who knows? It might’ (see Table 5, Sub-theme ‘Directly stated hope’).

Cannabis as an alternative to other medications

For many interviewees, medicinal cannabis was described as a preferable, more ‘natural’ (P10F, agreed) or ‘herbal’ (P14F, agreed) alternative to other medications for symptom management, prompting patients to consider participation in the trial (see Table 6, Sub-theme ‘Natural’). Such perceptions may reflect patients’ relative lack of consultation with health professionals and limited knowledge of cannabis (medicinal or recreational). Only 2 participants described consulting a health care professional outside of the trial team to inform their decision making. Others saw medicinal cannabis as a ‘gentle’ (P12M, agreed) alternative to current pharmaceutical interventions that were considered to have undesirable side-effects (see Table 6, Sub-theme ‘Fewer/less intense side-effects’) or saw MedCan as a possible way to ‘cut back’ (P25F, agreed) their in-take of medications overall (see Table 6, Sub-theme ‘Substitution’).

Perceived benefit to others: altruism as a driver for trial participation

Aligned with previous scholarship on RCT recruitment [7, 9], altruism, or benefits to others, was another common driver behind patients’ decisions to participate (see Table 7, Sub-theme ‘Broad’). For some, such altruism was combined with a belief that such a benefit would include testing of medicinal cannabis’ anti-cancer properties, that the trial would improve ‘the possibility of…the next person surviving’ (P11M, agreed; see Table 7, Sub-theme ‘Anti-cancer’). For others, it was combined with a hope that the trial would inform efforts to further de-criminalise and legalise marijuana in Australia (see Table 7, Sub-theme ‘Legalisation’).

Barriers to participation

Here we report barriers to trial participation. Self-selection was evident; some patients considered their symptom burden insufficient to warrant participation. Highlighting which findings are unique to MedCan, we first present barriers known to be common to RCTs. Subsequently, we present concerns specific to the population, study design and research setting: intersecting health and logistical challenges, restrictions on driving, fears of hallucinatory side-effects, cost and preferences for cannabis sourced outside of the clinical trial.

Common barriers

Here we first present barriers common to RCTs: wanting to avoid randomisation, fear of unknown side-effects and interactions with current medications, a preference to maintain one’s current pharmaceutical schedule, gatekeeper protection and unproven benefits to self [7, 49, 58, 65, 66]. Several interviewees declined participation due to randomisation, preferring to know if they were receiving a placebo or an intervention (see Table 8, Theme ‘Randomisation’). One went as far as asking, ‘Why should I be a guinea pig for someone else to find out whether it’s going to be any good for everyone else or not?’ (P25M, declined), contrasting the altruistic motivations described above and alluding to an aversion to the positioning of subjects in RCTs. For other interviewees, trial participation decision-making hinged on an assessment of current symptom burden, available symptom management options and the relative benefit of medicinal cannabis, or lack thereof (See Table 8, Theme ‘Uncertain benefit to self’). In weighing up benefits to self and risks [8], these interviewees saw the risk of possible side-effects and risk of unwanted interaction with their current medications as outweighing the benefits—particularly with the benefits not yet proven, and when current symptom burden was perceived to be low or sufficiently controlled (see Table 8, Sub-themes ‘Fear of side-effects’ and ‘Fear of interactions’). One interviewee expressed an extreme concern that the interaction of medicinal cannabis with his other medication could be fatal and cited advice from his general practitioner that medicinal cannabis was unlikely to be beneficial (see Table 8, Sub-themes ‘Fear of fatal interactions’ and ‘Clinician advice’).

Table 8 Barriers: common reasons for declining RCT participation
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Intersecting health and logistical concerns

As has been identified previously in trials in which potential participant cohorts may include patients who are older, frailer and/or face specific socio-economic challenges [49, 65, 67,68,69], the logistics of trial participation proved a significant barrier for many interviewees. MedCan study design required participants to attend weekly hospital appointments and access prescriptions (medicinal cannabis or placebo) via the hospital pharmacy. Several patients cited their current physical health and related limitations in their capacity to travel to attend regular hospital appointments as factors in their decision to decline trial participation. Interviewee P44M (declined), for example, described his ‘exercise tolerance as abysmal’, preventing him from traversing the 100 m from the bus stop to the hospital necessary to attend weekly appointments (see Table 9, Sub-theme ‘Physical health’). These health challenges often intersected with and compounded other challenges: required travel time, cost and inconvenience of public transport exacerbating time poverty and financial concerns (see Table 9, Sub-themes ‘Transport’, ‘Time’ and ‘Distance’). One interviewee stated: ‘I couldn’t see me coming in every week…. We live not that far away, but we come in on the train and it’s a long time. I’m just so tired and everything from the cancer that it just - yeah… [And] if I come in the car, it’s expensive’ (P16F, declined).

Table 9 Intersecting barriers: physical health and study-design logistics
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Concerns regarding medicinal cannabis

Several barriers to participation specific to medicinal cannabis emerged during analysis. Most prominent, the trial requirement for MedCan Pilot and 2 (both of which involve THC) to discontinue driving featured heavily in decision-making for some interviewees (see Table 10, Theme ‘Driving restrictions’). A few interviewees identified concerns about medicinal cannabis and/or marijuana more generally, such as a fear that medicinal cannabis would cause them to experience hallucinations or a high (see Table 10, Theme ‘Fear of getting “high”’). Though access to medicinal cannabis (or placebo) was free to participants while on MedCan, cost of future access to medicinal cannabis posed a barrier to some (see Table 10, Theme ‘Cost’). A trial requirement that participants cease current cannabis use prior to enrolling in the trial, and the related risk of being randomised to the placebo arm, featured as barriers for a minority (see Table 10, Theme ‘Staying on Cannabis’). For one interviewee, a decision to decline trial participation was based on a perception that the cannabis they acquire informally has fewer additives than the medicinal cannabis available through MedCan (see Table 10, Theme ‘Preference for unaltered cannabis’).

Table 10 Barriers: specific to cannabis
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Discussion

TalkingMedCan offers novel insight into perceptions of medicinal cannabis from patients’ perspectives in an Australian palliative care setting, and related enablers of and barriers to recruitment. Overall, findings show the merits of nesting qualitative sub-studies into RCTs, to uncover in situ recruitment challenges related to the setting, intervention and study population. The insights garnered supported revisions made to subsequent RCT study designs, with implications for medicinal cannabis RCT research more broadly.

Our study found curiosity in the intervention, perceived self-benefit and altruism to be central MedCan participation enablers. Participants were motivated by a desire to manage their symptoms using a ‘natural’ treatment with few expected adverse effects. Others have similarly identified perceived benefits to self and others [7, 9,10,11], along with patient enthusiasm, as participant enablers—adding to the limited but growing trend of scholarship reporting enablers to RCT participation, not just barriers [49]. Interest in medicinal cannabis specifically, as a milder ‘herbal’ intervention, likely reflects the growing aversion to opioids [70] and increasing interest in cannabis and its legalisation in Australia [41, 43].

Many interviewees described a desire to exhaust all options in symptom burden relief as a reason for taking part in the trial, particularly if conventional options were deemed insufficient or problematic. In some interviewees, discussions of exhausting all options for symptom burden relief blurred with exhausting all options for a cure or life-prolonging interventions—a common motivation behind oncology RCT participation [66]. This finding, however, raises questions aligned with research in other oncology populations [10, 71], of potential participants’ understanding of the trial intervention, and how this understanding relates to participation decision-making and intentions following the trial.

There was little discordance between perspectives on trial participation found in this study and perspectives on medicinal cannabis more broadly in Australia, with studies suggesting a general acceptance of and lack of concern regarding medicinal cannabis for treatment of physical and mental health conditions [40, 41], including use amongst cancer patients [28]. A minority of interviewees held expectations—ranging from dim to direct hope—that medicinal cannabis could be curative, again aligned with existing Australian studies [43].

Key barriers underpinning decisions to decline participation in MedCan included gatekeeper influence, perceptions of risks outweighing benefits and aversion to randomised trials of unproven interventions. These reflect and confirm well-established barriers within the literature on RCT participation decision-making [8, 13, 49, 58, 66]. Specifically, when symptom burden was being sufficiently managed, several participants expressed a fear that trial participation would ‘upset the apple cart’—adversely interacting with their careful regime of medications. Others self-assessed their own health status, symptom burden and consequent potential to benefit and declined to participate because of uncertain benefit.

The most prominent barriers related to the study requirements, its setting and legal restrictions. MedCan participants were asked to regularly attend appointments at the hospital to assess changes in symptom burden and fill their prescriptions, and aligned with current laws, patients enrolled in MedCan Pilot and 2 were not permitted to drive a car. Low stamina and difficulty obtaining transportation led to some declining to participate. Team et al. [49] describe such difficulties as study-related and participant-related barriers; frailty and fatigue preventing participation are common in RCTs with older participants [58, 65]. This finding also highlighted setting-specific considerations, regarding the city’s transport system, and supported a recommended revision to our study design. In a subsequent RCT, patients are given the option to attend appointments related to trial participation in person or via telephone appointments. The number of hospitals and hospital pharmacies involved has also been extended to include regional and rural hospitals, decreasing the travel burden associated with participation. Such revisions are necessary to accommodate potential future COVID-19 public health restrictions, while also responding to in situ needs of study participants.

Our study also identified barriers specific to medicinal cannabis: concerns about experiencing a substance-induced high, future cost and preferences to maintain their use of recreational cannabis for medicinal purposes. While these findings support research showing concerns related to medicinal cannabis are relatively minimal in Australia [43], they also indicate that such concerns are distinct and worthy of consideration. In contrast to research conducted in North America and Israel [30, 35], stigma did not appear to be a prominent concern amongst interviewees. These finding suggest that barriers to RCT participation are both common and context-specific [49]; studies are always embedded within hospital, cultural and urban systems, with distinct policies, legal-political structures, urban density or sprawl and associated public transportation systems. Thus, while some have called for a ‘methodological shift’ toward employing the existing ‘wealth of knowledge’ on RCT recruitment challenges, rather than accumulating further evidence [13], this study shows the value of nesting qualitative sub-studies into RCTs: identifying and countering intervention- and setting-specific hurdles [14].

Insights for medicinal cannabis RCTs

Interest in medicinal cannabis is high [26], driven by strong public interest and word of mouth [35]. It is noteworthy that few interviewees in this study described seeking or receiving information about medicinal cannabis from a health care professional, instead more often opting to obtain information and opinions from popular media, family, and friends. As such, suggestions within the RCT recruitment literature that focus on increasing awareness of the health problem and of the benefits of the intervention [7, 9] are to some degree already attended to within the context of RCTs of medicinal cannabis in advanced cancer care settings—patients have a high level of awareness of the intervention. Health professionals, however, need a stronger evidence base to guide patients with confidence [26], and this warrants further RCTs into medicinal cannabis in palliative and other care settings.

Tailored insights are needed to address specific recruitment and design challenges in this setting. Here, we offer suggestions for others designing RCTs and recruiting patients with advanced cancer to medicinal cannabis RCTs.

  • Foreground patients’ and families’ strong desires for hope [72,73,74]. In communication with patients prior to initiating consent, check that prospective participants understand the aim of the intervention, specifically that medicinal cannabis is unlikely to be curative.

  • Emphasise the potential for findings to inform policy and practice, providing evidence for legislative decision making.

  • Consider the research setting. Holding follow-up appointments via telephone or at community healthcare centres [49] and facilitating dispensary at local pharmacies may make the RCT more accessible to those prohibited from driving or who would otherwise struggle with significant travel requirements. Alternatively, taxi vouchers may help to lessen the financial, support and fatigue challenges associated with hospital visits [49].

Study strengths and limitations

Our study is the first to explore advanced cancer patients’ perspectives on enablers and barriers to participation in an Australian medicinal cannabis RCT for symptom burden relief. Although previous research contributes important understanding of common facilitators and impediments to RCT participation [7, 8, 49] as well as Australian patients’ perceptions of medicinal cannabis [28, 43], this study offers findings specific to both this population and intervention. A further strength is the inclusion of not only eligible patients who agreed to participate in the RCT, but also those who declined.

A limitation of this study could be the relatively homogeneous sample, with limited cultural, socio-economic, age and geographical diversity. Few participants described cultural backgrounds outside of the majority population in Australia; none identified as Aboriginal or Torres Strait Islander. Most participants described completing secondary school; few had achieved post-secondary qualifications.

Conclusion

TalkingMedCan provided insight into enablers and barriers to recruitment, supporting revisions to subsequent study designs. Findings offer novel insight into recruitment considerations specific to this population and intervention, and corroborate research showing concerns regarding cannabis are minimal and distinct in Australia, with a minority of patients holding curative expectations or concerns about serious side-effects. Future research should explore how the revisions to study design suggested here—foregrounding hope, emphasising the potential for RCTs to lead to policy change, and allowing participation via telehealth—change enablers and barriers to recruitment. Overall, findings support calls for a context-sensitive approach to RCT design, suggesting the merits of embedding qualitative sub-studies into RCTs to identify recruitment challenges that may be unique to the intervention, setting and population.

Availability of data and materials

Data generated and analysed for the current study are available to suitably qualified individuals by request, from the corresponding author, subject to HREC approval.

References

  1. Zarhin D, Negev M, Vulfsons S, Sznitman SR. “Medical cannabis” as a contested medicine: fighting over epistemology and morality. Sci Technol Hum Values. 2020;45(3):488–514.

    Article  Google Scholar 

  2. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:e000496.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Graham M, Lucas CJ, Schneider J, Martin JH, Hall W. Translational hurdles with cannabis medicines. Pharmacoepidemiol Drug Saf. 2020;29(10):1325–30.

    Article  PubMed  Google Scholar 

  4. Martin JH, Hill C, Walsh A, Efron D, Taylor K, Kennedy M, et al. Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience. Trials. 2020;21(1):1–7.

    Article  Google Scholar 

  5. LeBlanc TW, Lodato JE, Currow D, Abernethy AP. Overcoming recruitment challenges in palliative care clinical trials. J Oncol Pract. 2013;9(6):277–82.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Briel M, Olua KK, Ev E, Kasenda B, Alturki R, Agarwal A, et al. A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable. J Clin Epidemiol. 2016;80:8–15.

    Article  PubMed  Google Scholar 

  7. Houghton C, Dowling M, Meskell P, Hunter A, Gardner H, Conway A, et al. Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020;10(10):MR000045.

    PubMed  Google Scholar 

  8. Phelps EE, Tutton E, Griffin X, Baird J. A mixed-methods systematic review of patients’ experience of being invited to participate in surgical randomised controlled trials. Soc Sci Med. 2020;253:112961.

    Article  PubMed  Google Scholar 

  9. Caldwell PHY, Hamilton S, Tan A, Craig JC. Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med. 2010;7(11):e1000368.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Prout HC, Barham A, Bongard E, Tudor-Edwards R, Griffiths G, Hamilton W, et al. Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study. Trials. 2018;19:419.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Wright JR, Whelan TJ, Schiff S, Dubois S, Crooks D, Haines PT, et al. Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision. J Clin Oncol. 2004;22(21):4312–8.

    Article  PubMed  Google Scholar 

  12. Mills N, Blazeby JM, Hamdy FC, Neal DE, Campbell B, Wilson C, et al. Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients’ treatment preferences. Trials. 2014;15:323.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Scantlebury A, McDaid C, Brealey S, Cook E, Sharma H, Ranganathan A, et al. Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials. Trials. 2021;22:461.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Husbands S, Caskey F, Winton H, Gibson A, Donovan JL, Rooshenas L. Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care. Trials. 2019;20:224.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, et al. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021;50(6):1988–96.

    Article  PubMed  Google Scholar 

  16. Sedrak MS, Freedman RA, Cohen HJ, Muss HB, Jatoi A, Klepin HD, et al. Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Clin. 2021;71(1):78–92.

    Article  PubMed  Google Scholar 

  17. Parks RM, Holmes HM, Cheung K-L. Current challenges faced by cancer clinical trials in addressing the problem of under-representation of older adults: a narrative review. Oncol Ther. 2021;9(1):55–67.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Habicht DW, Witham MD, McMurdo MET. The under-representation of older people in clinical trials: barriers and potential solutions. J Nutr Health Aging. 2008;12(3):194–6.

    Article  CAS  PubMed  Google Scholar 

  19. White C, Gilshenan K, Hardy J. A survey of the views of palliative care healthcare professionals towards referring cancer patients to participate in randomized controlled trials in palliative care. Support Care Cancer. 2008;16(12):1397–405.

  20. White CD, Hardy JR, Gilshenan KS, Charles MA, Pinkerton CR. Randomised controlled trials of palliative care – a survey of the views of advanced cancer patients and their relatives. Eur J Cancer. 2008;44(13):1820–8.

  21. Agar M. Medicinal cannabinoids in palliative care. Br J Clin Pharmacol. 2018;84(11):2491–4.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Martin JH, Bonomo YA. Medicinal cannabis in Australia: the missing links. Med J Aust. 2016;204(10):371–3.

    Article  PubMed  Google Scholar 

  23. Mücke M, Weier M, Carter C, Copeland J, Degenhardt L, Cuhls H, et al. Systematic review and meta-analysis of cannabinoids in palliative medicine. J Cachexia Sarcopenia Muscle. 2018;9(2):220–34.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Kaufmann CN, Kim A, Miyoshi M, Han BH. Patterns of medical cannabis use among older adults from a cannabis dispensary in New York state. Cannabis Cannabinoid Res. 2020;7(2):224–30.

  25. Kim A, Kaufmann CN, Ko R, Li Z, Han BH. Patterns of medical cannabis use among cancer patients from a medical cannabis dispensary in New York state. J Palliat Med. 2019;22(10):1196–201.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Panozzo S, Le B, Collins A, Weil J, Whyte J, Barton M, et al. Who is asking about medicinal cannabis in palliative care? Intern Med J. 2020;50(2):243–6.

    Article  PubMed  Google Scholar 

  27. Luba R, Earleywine M, Farmer S, Slavin M. Cannabis in end-of-life care: examining attitudes and practices of palliative care providers. J Psychoactive Drugs. 2018;50(4):348–54.

    Article  PubMed  Google Scholar 

  28. Wilson A, Davis C. Attitudes of cancer patients to medicinal cannabis use: a qualitative study. Aust Soc Work. 2021;75(2):192–204.

  29. Harrop E, Walker L, Catalano RF, Haggerty K. Meds, myths, and marijuana: adolescents with CHEDS. J Adolesc Health. 2015;56(2):S28–S9.

    Article  Google Scholar 

  30. Satterlund TS, Lee JP, Moore RS. Stigma among California’s medical marijuana patients. J Psychoactive Drugs. 2015;47(1):10–7.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Troutt WD, DiDonato MD. Medical cannabis in Arizona: patient characteristics, perceptions, and impresisons of medical cannabis legalization. J Psychoactive Drugs. 2015;47(4):259–66.

    Article  PubMed  Google Scholar 

  32. Kvamme SL, Pedersen MM, Alagem-Iversen S, Thylstrup B. Beyond the high: mapping patterns of use and motives for use of cannabis as medicine. Nordisk Alkohol Nark. 2021;38(3):270–92.

    PubMed  PubMed Central  Google Scholar 

  33. Pedersen W, Sandberg S. The medicalisation of revolt: a sociological analysis of medical cannabis users. Sociol Health Illn. 2013;35(1):17–32.

    Article  PubMed  Google Scholar 

  34. Sznitman SR, Bretteville-Jensen AL. Public opinion and medical cannabis policies: examining the role of underlying beliefs and national medical cannabis policies. Harm Reduct J. 2015;12(1):46.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Waissengrin B, Urban D, Leshem Y, Garty M, Wolf I. Patterns of use of medical cannabis among Israeli cancer patients: a single institution experience. J Pain Symptom Manag. 2015;49(2):223–30.

    Article  Google Scholar 

  36. Wagner A, Polak P, Świątkiewicz-Mośny M. From community of practice to epistemic community – law, discipline and security in the battle for the legalisation of medical cannabis in Poland. Sociol Health Illn. 2021;43(2):316–35.

    Article  PubMed  Google Scholar 

  37. Caldicott D, Sinclair J, Sheridan L, Eckermann S. Medicinal cannabis and the tyranny of distance: policy reform required for optimizing patient and health system net benefit in Australia. Appl Health Econ Health Policy. 2018;16(2):153–6.

    Article  PubMed  Google Scholar 

  38. Drosdowsky A, Blaschke S, Koproski T, Fullerton S, Thackerar A, Ellen S, et al. Cancer patients’ use of and attitudes towards medicinal cannabis (vol 44, pg 650, 2020). Aust Health Rev. 2020;44(4):656–5.

    Article  PubMed  Google Scholar 

  39. Karanges EA, Suraev A, Elias N, Manocha R, McGregor IS. Knowledge and attitudes of Australian general practitioners towards medicinal cannabis: a cross-sectional survey. BMJ Open. 2018;8(7):e022101.

    Article  PubMed  PubMed Central  Google Scholar 

  40. Lintzeris N, Driels J, Elias N, Arnold JC, McGregor IS, Allsop DJ. Medicinal cannabis in Australia, 2016: the Cannabis as Medicine Survey (CAMS-16). Med J Aust. 2018;209(5):211–6.

    Article  PubMed  Google Scholar 

  41. Lintzeris N, Mills L, Suraev A, Bravo M, Arkell T, Arnold JC, et al. Medical cannabis use in the Australian community following introduction of legal access: the 2018-2019 Online Cross-Sectional Cannabis as Medicine Survey (CAMS-18). Harm Reduct J. 2020;17(1):1–37.

    Article  Google Scholar 

  42. Good P, Haywood A, Gogna G, Martin J, Yates P, Greer R, et al. Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo controlled, randomised clinical trial of efficacy and safety of cannabidiol (CBD). BMC Palliat Care. 2019;18(1):110.

  43. Luckett T, Phillips J, Lintzeris N, Allsop D, Lee J, Solowij N, et al. Clinical trials of medicinal cannabis for appetite-related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation. Intern Med J. 2016;46(11):1269–75.

    Article  CAS  PubMed  Google Scholar 

  44. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Hawthorne: Aldine de Gruyter; 1967.

    Google Scholar 

  45. O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open. 2013;3(6):e002889.

    Article  PubMed  PubMed Central  Google Scholar 

  46. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321(7262):694–6.

  47. O’Cathain A, Goode J, Drabble SJ, Thomas KJ, Rudolph A, Hewison J. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study. Trials. 2014;15(1):215.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Davis K, Minckas N, Bond V, Clark CJ, Colbourn T, Drabble SJ, et al. Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions. Trials. 2019;20(1):329.

    Article  PubMed  PubMed Central  Google Scholar 

  49. Team V, Bugeja L, Weller CD. Barriers and facilitators to participant recruitment to randomised controlled trials: a qualitative perspective. Int Wound J. 2018;15:929–42.

    Article  PubMed  PubMed Central  Google Scholar 

  50. French C, Stavropoulou C. Specialist nurses’ perceptions of inviting patients to participate in clinical research studies: a qualitative descriptive study of barriers and facilitators. BMC Med Res Methdol. 2016;16:96.

    Article  Google Scholar 

  51. Gleeson P. The challenges of medicinal cannabis to the political legitimacy of therapeutic goods regulation in Australia. Melb Univ Law Rev. 2019;43(2):558–604.

    Google Scholar 

  52. Good PD, Greer RM, Huggett GE, Hardy JR. An open-label pilot study testing the feasibility of assessing total symptom burden in trials of cannabinoid medications in palliative care. Journal of Palliative Medicine. 2020;23(5):650–5.

  53. Hardy J, Haywood A, Gogna G, Martin J, Yates P, Greer R, et al. Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: A double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Trials. 2020;21:611.

  54. Melnikov S, Aboav A, Shalom E, Phriedman S, Khalaila K. The effect of attitudes, subjective norms and stigma on health-care providers’ intention to recommend medicinal cannabis to patients. Int J Nurs Pract. 2021;27(1):e12836–n/a.

    Article  PubMed  Google Scholar 

  55. Gardiner KM, Singleton JA, Sheridan J, Kyle GJ, Nissen LM. Health professional beliefs, knowledge, and concerns surrounding medicinal cannabis - a systematic review. PLoS One. 2019;14(5):e0216556.

    Article  PubMed  PubMed Central  Google Scholar 

  56. Ryan JE, McCabe SE, Boyd CJ. Medicinal cannabis: policy, patients, and providers. Policy Polit Nurs Pract. 2021;22(2):126–33.

    Article  PubMed  PubMed Central  Google Scholar 

  57. Low J. Unstructured interviews and health research. In: Saks M, Allsop J, editors. Research health: Qualitative, quantitative and mixed methods. London: Sage; 2007. p. 74–91.

    Google Scholar 

  58. Cardenas V, Rahman A, Giuloni J, Coulourides Kogan A, Enguidanos S. Patient and physician perspectives on engaging in palliative and healthcare trials: a qualitative descriptive study. BMC Palliat Care. 2021;20(158):1–11.

    Google Scholar 

  59. Guetterman T. Descriptions of sampling practices within five approaches to qualitative research in education and the health sciences. Forum Qual Soc Res. 2015;16:25.

    Google Scholar 

  60. Charmaz K. Constructing grounded theory: a practical guide through qualitative analysis. Thousand Oaks: Sage; 2006.

    Google Scholar 

  61. Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qual Res Sport Exerc Health. 2019;11(4):589–97.

    Article  Google Scholar 

  62. Braun V, Clarke V. Thematic analysis. In: Cooper H, Camic P, Long D, Panter AT, Rindskopf D, Sher K, editors. APA handbook of research methods in psychology. 2nd ed. Washington, D. C.: American Psychological Association; 2012. p. 57–71.

    Google Scholar 

  63. Marks DF, Yardley L. Content and thematic analysis. In: Marks DF, Yardley L, editors. Research methods for clinical and health psychology. London: Sage Publications; 2004. p. 56–69.

    Chapter  Google Scholar 

  64. Olson R, Smith A, Good P, Dudley M, Gurgenci T, Hardy J. Patient perspectives on the future of medicinal cannabis in Australia: Financial barriers, regulation, and overcoming stigma. Health Expectations. under review.

  65. Jenkins V, Farewell D, Batt L, Maughan T, Branston L, Langridge C, et al. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103(12):1801–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  66. Dias AL, Chao JH, Lee D, Wu Y, Kloecker GH. Patient perceptions concerning clincial trials in oncology patients. Contemp Clin Trials Commun. 2016;21(4):179–85.

    Article  Google Scholar 

  67. Unger JM, Gralow JR, Albain KS, Ramsey SD, Hershman DL. Patient income level and cancer clinical trial participation: a prospective survey study. JAMA Oncol. 2016;2(1):137–9.

    Article  PubMed  PubMed Central  Google Scholar 

  68. Unger JM, Hershman DL, Albain KS, Moinpour CM, Petersen JA, Burg K, et al. Patient income level and cancer clinical trial participation. J Clin Oncol. 2013;31(5):536–42.

    Article  PubMed  PubMed Central  Google Scholar 

  69. Price KN, Lyons AB, Hamzavi IH, Hsiao JL, Shi VY. Facilitating clinical trials participation of low socioeconomic status patients. Dermatology. 2021;237(5):843–6.

    Article  PubMed  Google Scholar 

  70. Islam MM, McRae IS, Mazumdar S, Taplin S, McKetin R. Prescription opioid analgesics for pain management in Australia: 20 years of dispensing. Intern Med J. 2016;46(8):955–63.

    Article  CAS  PubMed  Google Scholar 

  71. Ellis PM, Dowsett SM, Butow PN, Tattersall MHN. Attitudes to randomized clinical trials amongst out-patients attending a medical oncology clinic. Health Expect. 1999;2(1):33–43.

    Article  PubMed  PubMed Central  Google Scholar 

  72. Kennedy V, Lloyd-Williams M. Maintaining hope: communication in palliative care. In: Stiefel F, editor. Communication in cancer care. Recent results in cancer research. Berlin: Springer; 2006.

    Google Scholar 

  73. Olson RE. Managing hope, denial or temporal anomie? Informal cancer carers' accounts of spouses' cancer diagnoses. Social Science & Medicine. 2011;73(6):904–11.

  74. Kube T, Blease C, Ballou SK, Kaptchuk TJ. Hope in medicine: applying multidisciplinary insights. Perspect Biol Med. 2019;62(4):591–616.

    Article  PubMed  Google Scholar 

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Acknowledgements

The authors wish to thank the TalkingMedCan participants for their time and insights. We are grateful for the research support provided by Thomas Dinala, Taylan Gurgenci, Karyn Foster and Zhaoxi Zheng.

Funding

Funding for this study was provided by a National Health and Medical Research Council (NHMRC) of Australia Medical Research Future Fund (MRFF) Grant (APP1140160, 2018-2022) and a Mater Clinical Research Seeding Grant (2017–2019). None of these funders had a role in the study design; collection, analysis or interpretation of the data; writing the manuscript; or the decision to submit the paper for publication.

Author information

Authors and Affiliations

  1. School of Social Science, The University of Queensland, Michie Building #9, St Lucia, QLD, 4072, Australia

    Rebecca E. Olson, Alexandra Smith & Morgan Dudley

  2. Department of Palliative and Supportive Care Mater Health Services, Mater Research-University of Queensland, Raymond Terrace, South Brisbane, QLD, Australia

    Georgie Huggett, Phillip Good & Janet Hardy

  3. Department of Palliative Care, St. Vincent’s Private Hospital Brisbane, 411 Main Street, Kangaroo Point, QLD, Australia

    Phillip Good

Authors
  1. Rebecca E. Olson
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  2. Alexandra Smith
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  3. Georgie Huggett
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  4. Phillip Good
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  5. Morgan Dudley
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  6. Janet Hardy
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Contributions

RO designed the qualitative sub-study, provided oversight on and contributed to data collection and analysis and drafted the final manuscript. AS led the data analysis and was a major contributor in writing the manuscript. GH managed recruitment, including informed consent, and was a major contributor in writing the manuscript. PG contributed to the study design, data analysis and editing of the final version of the manuscript. MD was a major contributor in writing the manuscript. JH contributed to the study design and data analysis and was a major contributor in editing the final version of the manuscript. All authors read and approved the final manuscript.

Authors’ information

RO is an Associate Professor of Sociology and experienced qualitative researcher. AS is a Medical Anthropologist, experienced qualitative researcher and a clinical trials and research manager. GH is a nurse and clinical trials coordinator. PG is Director of Palliative Medicine at St Vincent’s Private Hospital, Brisbane, and an experienced clinical trials researcher. MD has an honours degree in social science and has experience in conducting qualitative research in health contexts. JH is Director of Palliative and Support Care across the Mater group and an experienced clinical trials researcher.

Corresponding author

Correspondence to Rebecca E. Olson.

Ethics declarations

Ethics approval and consent to participate

Ethical approval for this study was obtained from the Human Research Ethics Committees at the Mater Hospital (HREC/17/MHS/97) and St Vincent’s Hospital (HREC 17/27). All participants provided their written consent.

Consent for publication

Not applicable. All personal data is de-identified.

Competing interests

The authors declare that they have no competing interests.

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Olson, R.E., Smith, A., Huggett, G. et al. Using a qualitative sub-study to inform the design and delivery of randomised controlled trials on medicinal cannabis for symptom relief in patients with advanced cancer. Trials 23, 752 (2022). https://doi.org/10.1186/s13063-022-06691-1

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  • DOI: https://doi.org/10.1186/s13063-022-06691-1

Keywords

  • RCT
  • Palliative care
  • Medicinal cannabis
  • Australia
  • Qualitative
  • Recruitment
  • Patient and public

Trials

ISSN: 1745-6215