Skip to main content
Download PDF

Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial

Trials volume 18, Article number: 304 (2017) Cite this article

Abstract

Background

Family caregivers (FC) often experience higher distress levels than their relative with cancer. Many cancer centers have implemented distress screening programs, but most of them concentrate their efforts on patients, with little attention to their FC. To fill this gap, a pragmatic intervention has been designed to improve supportive care for FC of patients with lung cancer. This article describes the study protocol of a single-center randomized controlled trial to assess its effectiveness.

Methods/design

A total of 120 lung cancer patients and their FC are randomly assigned to the experimental group (exposed to intervention, N = 60) or to the control group (usual care, N = 60). The intervention includes: (1) systematic FC distress screening and problem assessment near their relative’s cancer diagnosis, and every 2 months, (2) privileged contact with an oncology nurse (ON) away from the patient to address FC problems and (3) liaison by the ON with the family physician of FC reporting high distress (thermometer score ≥5/10), or problems relying on FP expertise. In both groups, FC, patient and process-of-care outcomes are measured at baseline and every 3 months, up to 9 months. The primary endpoint is FC distress measured by the Hospital Anxiety and Depression Scale (HADS) and the Psychological Distress Index used in the Quebec Health Survey (PDQHS). Individual interviews with 10 FC and a focus group with the oncology team will be conducted at the study end to further document the effectiveness of the intervention and its impact on quality of life (for FC) and practice organization (for the oncology team).

Discussion

This trial will assess the effectiveness of an innovative intervention based on interprofessional collaboration between primary care and oncology care. It targets a population in great need, yet often neglected, and has the potential to clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.

Trial registration

ClinicalTrials.gov, ID: NCT02531464. Registered on 15 July 2015.

Peer Review reports

Background

A diagnosis of cancer is emotionally threatening not only for patients but also for their family caregivers (FC) who witness and share much of the illness experience of their relative [1]. Along the cancer care trajectory, FC play a critical role in providing ongoing homecare and assistance to their loved one [1]. However, they are often unprepared to play their role and may experience growing levels of distress, as their relative’s condition deteriorates. Even though many FC are coping quite well, studies show that 10 to 50% of them report high distress [2, 3] which is often more severe than in patients [2, 4,5,6,7], and it may persist over time, with a potential impact on their physical, emotional and social health [1, 4, 8]. FC of lung cancer patients are particularly vulnerable [7] and likely to be distressed [9,10,11,12,13] because of a rapid evolution [2, 8, 14] and decline in their relative’s functional status associated with symptoms and treatment side effects [1, 15,16,17].

FC may often feel unsupported in their role [18] and would need more information and tips to fulfill it [18]. Their unmet needs may compromise their quality of life (QoL) [19] and contribute to their distress [20], but also they may adversely impact on their relative’s distress [21]. Because of the interrelation of the patient-FC dyad experience, identifying and meeting FC needs should be considered as an integral part of cancer services [22,23,24,25]. It is recommended to assess FC distress and needs early after diagnosis, and to reassess them regularly with cancer progression [26, 27] in order to support them and help them play their role in patient assistance and ongoing care throughout the care trajectory. However, little is known on the most effective interventions to develop and how to implement them into routine practice [13, 27].

As recommended by many expert groups and health authorities around the world [22,23,24,25], many cancer centers have implemented distress screening programs. However, most of them concentrate their efforts mainly on patients. In order to fill this gap, an intervention was developed to improve supportive care for FC.

Development of the intervention

The multifaceted intervention was developed according to the knowledge gained from the academic literature, from previous research [28] and from recommendations of expert groups and health authorities [22,23,24,25]. The Screening for Distress tool currently used for cancer patients in Quebec, Canada (including the Distress Thermometer with the Canadian Problem Checklist and the Edmonton Symptom Assessment Scale [29, 30]) was adapted to the FC context (Fig. 1). Then, a pilot study was conducted, consisting in individual interviews with 12 FC of patients at different phases of their lung cancer (near diagnosis, during chemo/radiation therapy, after the end of treatments), to get their comments and impressions regarding this tool and the other components of the intervention. FC also gave their opinion on the most appropriate timing and frequency for completing the Screening for Distress tool, and were invited to suggest any other strategies that they would consider useful to fulfill their needs. In addition, a focus group was conducted with members of the IUCPQ oncology team and their decision-makers, (where the intervention is tested), to ensure its acceptability and feasibility in their practice. IUCPQ is a tertiary care center in cardiology and pulmonology in Quebec City (Quebec, Canada) where more than 700 new patients with lung cancer are followed each year. The oncology team (OT) is composed of pulmonologists responsible for the treatment of these patients, oncology pivot nurses (OPN) who play a role of resource person and cancer navigator for patients and their family (each patient has a designated OPN to refer to whenever needed), oncology nurses, social workers, a psycho-oncologist, pharmacists and nutritionists. Finally, a focus group with eight family physicians (FP) from different community-based practice settings (private clinics, family medicine teaching units, community health centers) was conducted to ensure that the intervention was also acceptable and feasible in their practice.

Fig. 1
figure 1

Distress Screening tool adapted to the family caregiver (FC) context

Full size image

With the agreement of participants, individual interviews and focus group discussions were recorded to facilitate data collection. A content analysis of the recordings was performed independently by a research professional and one researcher to identify the modifications to the intervention that were suggested by the different participants. They compared their notes and jointly produced a summary discussed with the research team that served to adapt and refine the multifaceted intervention accordingly.

Objectives

The main objective of this study is to implement and assess the effectiveness of an intervention integrating community-based primary care with oncology care to improve supportive care for FC of lung cancer patients. More specifically, this trial aims to assess the effectiveness of the intervention on: (1) FC outcomes: distress (primary outcome), anxiety, depression, quality of life (QoL), needs, burden, perception of health, preparedness in caregiving, social support, care satisfaction, (2) Patient outcomes: distress, anxiety, depression, QoL, pain/other symptom relief, (3) Care process outcomes: FC and patient utilization of services. In addition, a qualitative component of the study will further document, in the experimental group, FC-perceived usefulness of the intervention and its effects on distress/QoL, and in the oncology team, the perceived usefulness of the intervention and its effects on their practice and organization of care.

Methods/design

A two arm-randomized controlled trial is conducted at a single center, the IUCPQ Pulmonary Oncology Clinic, to assess the effectiveness of the intervention (Fig. 2).

Fig. 2
figure 2

The multi-faceted intervention

Full size image

Description of the intervention

In the current practice at the IUCPQ Oncology Clinic, there is a systematic distress screening program for patients, but not for FC. In their role towards patients and their family throughout the cancer care trajectory, may provide some support and information to FC and, in rare occasions, refer them to appropriate resources. However, most of their interventions target patients, and only few FC receive support services. There is no systematic distress screening and problem assessment for FC, nor any standardized service and resource specifically dedicated to them. The study intervention directly targets FC of patients with lung cancer and aims to increase the support provided to them. In order to prevent contamination of the control group, an oncology nurse (ON) with the training of an OPN [31, 32] has been recruited specifically to administer the intervention to FC randomly assigned to the experimental group. The ON intervenes in addition to the usual care provided by an OPN to patients and their family. The finalized intervention includes three components and is summarized in Fig. 2:

  1. 1.

    Systematic distress screening and needs/problems assessment of family caregivers by the oncology nurse

    FC from the experimental group complete the adapted Screening for Distress tool early after the diagnosis of their relative, and every 2 months during the 9-month study. Whenever possible, they complete this tool when they accompany their relative at a regular visit to the clinic. Otherwise, arrangements are made by the ON to either schedule a specific visit for FC distress screening or mail them a copy of the screening tool and complete it with them by phone. The ON reviews the results of the Screening for Distress tool

  2. 2.

    Privileged contact of the family caregiver with the oncology nurse

    The ON meets all FC away from their relative, after their first completion of the distress screening and needs/problems assessment tool. This professional discusses with them results of this tool, and further assesses their needs in order to plan with them individualized problem-solving strategies, and, if necessary, refers them to professional resources from the IUCPQ Oncology Clinic or the community. The training as an OPN provides the ON the basic skills to support FC, acknowledging that it is normal for them to go through different emotions (anxiety, fear, sadness, helplessness, etc) in their situation, and counsels them on the importance of taking care of them and preserving time for them, while accompanying their relative. The ON provides community resources and educational material (in addition to what is usually given) related to their caregiving role, and helps them to become better prepared and more proactive in their role, also answering all remaining questions asked by FC. Then, every 2 months, the ON reviews FC results of the screening tool and meets those who present a high level of distress (thermometer score ≥5/10) or who indicate needing help. The ON follows-up on prior strategies put in place to help FC and adjusts them to the current situation. So the ON acts as a resource person for FC throughout the follow-up in oncology

  3. 3.

    Liaison by the oncology nurse with the FC family physician

    For FC reporting high levels of distress (thermometer score ≥5/10) or experiencing problems relevant to FP expertise, the ON transfers to their FP, information on their identified needs and level of distress, and also provides to them information on any strategy put in place or reference to other health professionals to respond to FC needs. The ON invites FP to give an appointment to their patient, and facilitates a shared follow-up of the FC when needed. If FC continue to present high levels of distress or many needs/problems at subsequent screenings, the ON transfers the information to their FP and organizes another appointment/follow-up. Most communications between the ON and FP occur by fax, but they may also communicate by phone if needed.

Study population

Patients diagnosed with a nonsurgical lung cancer (corresponding to more than 85% of all cases), having an estimated life expectancy of at least 4 months (to minimally ensure two data collections), and with FC identified by patients as their main caregiver, and who report having a regular FP, are invited to participate to the study by the OPN. FC are eligible independently of their health status. Using a computer-generated randomization list, these dyads are randomly assigned by the research team to either the experimental group (exposed to the intervention) or to the control group (usual care), as shown in Fig. 3. As the study focuses mainly on FC, they can participate even if their relative with cancer decides not to participate or withdraws before the end of the study. There is no blinding in this trial, so participants and the research team know the group allocation.

Fig. 3
figure 3

Trial flow diagram

Full size image

As FC distress is the primary outcome in this study, the sample size was calculated from the mean scores of distress found in a prior study conducted by our team with a similar population of FC of patients with lung cancer (unpublished abstract presented at the 16th World Congress of Psycho-Oncology, Lisbon, Portugal, 23 October 2014). Based on FC distress scores of respectively 13.7 ± 7.0 at the Hospital Anxiety Depression Scale (HADS) (range = 0–42) and of 23 ± 16 at the Psychological Distress Scale used in the Quebec Health Survey (PDSQHS) (range = 0–100), a sample size of 120 FC (60 per group) was calculated. Considering a 5% α error, a power of 80% and an anticipated withdrawal rate of 20% (due to patient deterioration or death), this sample size allows to detect a 33% difference in distress scores between the two groups which is considered clinically significant.

Procedures and data collection

At a regular visit of the patient who is most often accompanied by their FC, the OPN briefly explains the study to them and asks permission to transfer their phone number to the study team. Then, a research professional contacts them to present the study more extensively, get their agreement to participate and set an appointment with them to sign the Consent Form and begin the data collection with them. In both groups, the research professional interviews separately patients and FC at baseline and at 3-month intervals, for a maximum of 9 months, or until the patient’s death (maximum of four data collections), thus minimizing missing data (Fig. 3). Validated tools are used to collect all the study outcomes. At baseline, FC respond to basic questions related to their personal and medical characteristics. They also complete the following validated questionnaires:

  • Primary outcomes:

    • Distress measured by two instruments: (1.1) the HADS [33, 34], a 14-item instrument specifically designed to evaluate distress, anxiety and depression. For each item, the scale varies from 0 (most of the time) to 3 (never). Using the standard criteria suggested by authors of this instrument, distress scores are converted into two categories (absence/presence of distress) while anxiety and depression scores are converted into three (absence/suspected/significant anxiety or depression); (1.2) the global score of the abbreviated version of the PDSQHS [35, 36]. This14-item instrument was derived from the Psychiatric Symptoms Index [37] and has been used in the Quebec general population to estimate the prevalence of clinically significant distress (scores ≥80th percentile), so it permits the comparison of proportions of FC with high distress levels to the ones found in the general population. The PDSQHS scale varies from 1 (never) to 4 (very often).

  • Secondary outcomes:

    • Needs. The Home Caregiver Need Survey [38] is a 25-item tool covering four categories of needs (informational, practical, emotional and spiritual). FC indicate, for each need, its perceived importance, on a 0 (not important) to 4 (extremely important) scale, and how well it is satisfied (0 = unsatisfied to 4 = completely satisfied).

    • Psychological burden. The French version of the Caregiver Burden Scale in End of Life Care (CBS-EOLC) [39] is a 16-item instrument validated among FC who assist cancer patients in palliative phase. Items vary from 1 (never) to 4 (very often).

    • Preparedness for caregiving. The Preparedness for Caregiving Scale [40] measures the perceived readiness for multiple domains of the caregiving role (providing physical care, emotional support, setting up in-home support services and dealing with the stress of caregiving). This eight-item instrument uses a 0 (not at all prepared) to 4 (very well prepared) scale.

    • Quality of Life. The City of Hope-QoL Scale-Family Version [41] is a 37-item instrument measuring four QoL domains (physical, psychological, social and spiritual), with questions using a 0–10 scale.

    • Service and health care resource utilization. FC report the number of visits to their FP and to any other health/psychosocial professional, meetings to support groups, use of community resources (volunteer services, respite, help for housework, etc.), sick leave, and prescription of sleeping pills, anxiolytic or antidepressant medications.

Measures are also taken at similar intervals with FC relatives with lung cancer, since their physical and mental health may influence FC. At baseline, patients respond to basic questions related to their personal and medical characteristics, and their functional status based on the Karnofsky scale [42] which has a well-known correspondence to the Eastern Collaborative Oncology Group (ECOG) scale [43]. As for FC, they complete distress measures (PDSQHS and HADS) every 3 months, a Healthnnrelated QoL measure (European Organization for Research and Treatment of Cancer Quality of Life Core 30: EORTC QLQ-C30) [44], and service and health care resource utilization (frequency of emergency room (ER) visits, hospitalizations, homecare services or other services from the community health center). Figure 4 shows the schedule of enrollment, interventions and assessments for all participants.

Fig. 4
figure 4

Schedule of enrollment, interventions and assessments. FC: family caregiver, Pts: patients

Full size image

To monitor the administration of the intervention, additional information is collected with FC from the experimental group reporting high distress at screening: the communication with FP, strategies put in place and references to specific resources, as well as the number of FC visits or phone contacts.

In order to promote participant retention, data collections are usually scheduled on the day of a patient regular visit to the oncology clinic. If no visit is planned at the time of a data collection, the questionnaires are mailed to the participants and they are contacted by phone to determine the most convenient way to complete them (either by themselves or with the research professional who may go to their home or complete the questionnaires with them over the phone).

Data from the questionnaires are coded in two separate files and secured in a computer with a passcode. The computer is located in a locked room accessed only by the research team. A SPIRIT Checklist of all items recommended in a randomized controlled trial is included in Additional file 1.

Finally, individual interviews will be conducted with a subgroup of FC in the experimental group at the end of the study (N = 10 or until saturation) to document their perception of the intervention usefulness and effect on their QoL. Also, a focus group will be conducted with the OPN and others professionals of the IUCPQ OT, to assess their perception of the usefulness of the intervention and its effect on their practice and organization of care.

Analysis

The quantitative analysis plan first includes an evaluation of the adherence to the planned intervention by verifying for each FC from the experimental group: (1) the proportion of planned screening tools actually completed, (2) the proportion of liaisons with FP, (3) a descriptive analysis of all interventions performed by the ON (number of encounters, referrals, provision of educational material, etc.). Then, FC primary and secondary outcomes will be compared between the experimental and control groups at each data collection period. In addition, mixed models for repeated measures will be constructed with FC, patient and process-of-care outcomes to assess the intervention effectiveness. These analyses of variance for repeated measures will compare the fluctuation over time of FC distress and other variables between the experimental and control groups. Whenever significant changes are found within one group for certain outcomes over time, the mixed models for repeated measures will help to identify when the change occurred. Finally, McNemar tests will be used to compare FC and patient distress.

The qualitative analysis will consist in content analysis of the recordings of FC individual interviews and the focus group with the OT, based on Miles and Huberman methodology [45], to further document the perceived usefulness of the intervention and its effect on FC QoL and on the OT practice and organization of care. Each interview will be independently analyzed by a research professional and one researcher to ensure interobserver reliability. In case of disagreement, perceptions will be reviewed until a consensus is reached.

Discussion

FC play a crucial role in cancer patient care, representing their principal source of support [1]. However, they often have their own lives put into upheaval [2, 8, 13, 14] and neglect their health and needs to focus on supporting their relative with cancer [4, 46]. It is well recommended to provide FC with the resources, information and support needed to maintain good health, and to sustain their caregiving role [9, 27]. As emotional support appears to be an important part of their role in cancer care [47, 48], FP could be important actors in assessing FC health and advising them about resources to facilitate their caregiving role [49]. The long-standing relationship with their patients and their usual familiarity with patient social context put them in a strategic position to provide emotional support. It is, thus, reasonable to assume that FP may favorably influence FC distress when they accompany a relative diagnosed with cancer.

Systematic screening for distress programs has been implemented in many oncology centers, but their focus has been limited to cancer patients, with little intervention on FC. The intervention tested in this study aims to address this gap by targeting more particularly FC, a population in great need, yet often neglected. The intervention has been pilot-tested to ensure its acceptability for members of an oncology team working in a tertiary care hospital and for community-based FP, and also to confirm the appropriateness of the Screening for Distress tool, adapted to the FC context, as part of the intervention. Preliminary consultation with the main stakeholders involved is recognized as a fundamental step prior to the implementation of any innovative strategy. Without achieving such pilot work, there is a risk of jeopardizing the implementation of the intervention, thus reducing the possibility of finding any result at the evaluative phase.

This randomized trial assesses the effectiveness of an intervention using structures already in place to produce practice changes and combining simple realistic strategies of integrated care between primary care and oncology care that transfer into practice the main recommendations of expert groups and health authorities [22,23,24,25] to globally improve cancer supportive care.

To prevent confounding bias from variable organization of care, the study is restricted to a single center. However, if the intervention is proven effective, its essential conditions of success will be identified and could be replicated in other settings and extended to other cancer sites. The knowledge gained from the study findings may clearly enhance QoL for cancer patients and their FC.

Trial status

Recruiting.

Ethics approval and consent to participate

This study has received human ethics approval by the Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Research Ethics Committee (Approval number: 2016-2523, 21206).

Abbreviations

CBS-EOLC:

Caregiver Burden Scale in End of Life Care

ECOG:

Eastern Collaborative Oncology Group

EORTC:

European Organization for Research and Treatment of Cancer

ER:

Emergency room

FC:

Family caregiver

FP:

Family physician

HADS:

Hospital Anxiety Depression Scale

IUCPQ:

Institut Universitaire de Cardiologie et de Pneumologie de Québec

ON:

Oncology nurse

OPN:

Oncology pivot nurse

OT:

Oncology team

PDSQHS:

Psychological Distress Scale used in the Quebec Health Survey

Pts:

Patients

QLQ-C30:

Quality of Life Core 30

QoL:

Quality of life

References

  1. Juarez G, Ferrell B, Uman G, Podnos Y, Wagman LD. Distress and quality of life concerns of family caregivers of patients undergoing palliative surgery. Cancer Nurs. 2008;31(1):2–10.

    Article  PubMed  Google Scholar 

  2. Merckaert I, Libert Y, Lieutenant F, Moucheux A, Farvacques C, Slachmuylder JL, Razavi D. Desire for a formal psychological support among caregivers of patients with cancer: prevalence and implications for screening their needs. Psycho-Oncology. 2013;22(6):1389–95. doi:10.1002/pon.3153Epub2012Aug8.

    Article  PubMed  Google Scholar 

  3. Papastavrou E, Charlambous A, Tsangari H. Exploring the other side of cancer care: the informal caregiver. Eur J Oncol Nurs. 2009;13(2):128–36.

    Article  PubMed  Google Scholar 

  4. Wadhwa D, Burman D, Swami N, Rodin G, Lo C, Zimmermann C. Quality of life and mental health in caregivers of outpatients with advanced cancer. Psycho-Oncology. 2013;22(2):403–10. doi:10.1002/pon.2104. Epub 2011 Dec 2.

    PubMed  Google Scholar 

  5. Chambers SK, Girgis A, Occhipinti S, Hutchison S, Turner J, Morris B, Dunn J. Psychological distress and unmet supportive care needs in cancer patients and carers who contact cancer helplines. Eur J Cancer. 2012;21(2):213–23.

    Article  CAS  Google Scholar 

  6. Girgis A, Lambert SD, McElduff P, Bonevsky B, Lecathelinais C, Boyes A, Stacey F. Some things change, some things stay the same: a longitudinal analysis of cancer caregivers’ unmet supportive care needs. Psycho-Oncology. 2013;22(7):1557–64. doi:10.1002/pon.3166. Epub 2012 Sep 3.

    Article  PubMed  Google Scholar 

  7. Lambert SD, Harrison JD, Smith H, Bonevsky B, et al. The unmet needs of partners and caregivers of adults diagnosed with cancer: a systematic review. BMJ Support Palliat Care. 2012;2:224–30. doi:10.1136/bmjspcare-2012-000226.

    Article  PubMed  Google Scholar 

  8. Stenberg U, Ruland CM, Miaskowski C. Review of literature on the effects of caring for a patient with cancer. Psycho-Oncology. 2010;19(10):1013–25. doi:10.1002/pon.1670.

    Article  PubMed  Google Scholar 

  9. Persson UO, Wennman-Larsen A, Wengström Y, Gsutavsson P. Health-related quality of life in significant others of patients dying from lung cancer. Palliat Med. 2008;22:239–47.

    Article  CAS  PubMed  Google Scholar 

  10. Vrettos I, Kamposioras K, Kontodimopoulos N, Pappa E, Georgiadou E, Haritos D, Papadopoulos AA, Niakas D. Comparing health-related quality of life of cancer patients under chemotherapy and of their caregivers. Sci World J. 2012. doi:10.1100/2012/135283.

    Google Scholar 

  11. Siminoff LA, Wilson-Genderson M, Baker Jr S. Depressive symptoms in lung cancer patients and their family caregivers and the influence of family environment. Psycho-Oncology. 2010;19:1285–93. doi:10.1002/pon.1696.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Lambert SD, Girgis A, Lecathelinais C, Stacey F. Walking a mile in their shoes: anxiety and depression among partners and caregivers of cancer survivors at 6 and 12 months post-diagnosis. Support Care Cancer. 2013;21(1):75–85. doi:10.1007/s00520-012-1495-1497. Epub 2012 Jun 3.

    Article  PubMed  Google Scholar 

  13. Plant H, Moore S, Richardson A, Cornwall A, Medina J, Ream E. Nurses’ experience of delivering a supportive intervention for family members of patients with lung cancer. Eur J Cancer Care. 2011;20:436–44.

    Article  CAS  Google Scholar 

  14. Van Ryn M, Sanders S, Kahn K, et al. Objective burden, resources, and other stressors among informal cancer caregivers: a hidden quality issue? Psycho-Oncology. 2011;20(1):44–52.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Fujinami R, Otis-green S, Klein L, Sidhu R, Ferrell B. Quality of life of family caregivers and challenges faced in caring for patients with lung cancer. Clin J Oncol Nurs. 2012;16(6):E210–20.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Murray SA, Kendall M, Boyd K, Grant L, Highet G, Sheikh A. Archetypal trajectories of social, psychological and spiritual wellbeing and distress in family caregivers of patients with lung cancer: secondary analysis of serial interviews. BMJ. 2010;304:c2581.

    Article  Google Scholar 

  17. Ellis J. The impact of lung cancer on patients and carers. Chron Respir Dis. 2012;9(1):39–47.

    Article  PubMed  Google Scholar 

  18. Bee PE, Barnes P, Luker KA. A systematic review of informal caregivers’ need in providing home based end of life care to people with cancer. J Clin Nurs. 2009;18(10):1379–93.

    Article  PubMed  Google Scholar 

  19. Park SM, Kim YJ, Kim S, et al. Impact of caregivers’ unmet needs for supportive care on quality of terminal cancer care delivered and caregiver’s workforce performance. Support Cancer Care. 2010;18(6):699–706.

    Article  Google Scholar 

  20. Kim Y, Kashy DA, Spillers RL, Evans TV. Needs assessment of family caregivers of cancer survivors: three cohorts comparison. Psycho-Oncology. 2010;19(6):573–82.

    Article  PubMed  Google Scholar 

  21. Hodgkinson K, Butow P, Hunt G, Wise R, Hobbs K, Wain G. Life after cancer: couples’ and partners’ psychological adjustment and supportive care needs. Support Cancer Care. 2007;15(4):405–15.

    Article  CAS  Google Scholar 

  22. Canadian Hospice palliative Care Association. Voice in Health Policy. Strategic Policy Directions on the Role of Informal caregivers in Palliative and End-of-Life care. 2004. http://www.chpca.net/media/7904/VOICE_PROJECT-TRANSFORMING_POLICY-August2004-2.pdf. Accessed 28 Oct 2015.

  23. National Comprehensive Cancer Network. Distress management. Clinical practice guidelines. J Natl Compr Cancer Netw. 2003;1(3):344–74.

    Article  Google Scholar 

  24. National Institute for Clinical Excellence. Guidance on cancer services. Improving supportive and palliative care for adults with cancer. The manual. 2004. https://www.nice.org.uk/guidance/csg4/resources/improving-supportive-and-palliative-care-for-adults-with-cancer-pdf-773375005. Accessed 1 July 2017.

  25. Australia C. Clinical practice guidelines for the psychosocial care of adults with cancer. 2003. http://canceraustralia.gov.au/sites/default/files/publications/pca-1-clinical-practice-guidelines-for-psychosocial-care-of-adults-with-cancer_504af02682bdf.pdf. Accessed 28 Oct 2015.

  26. Fridriksdorrir N, Saevarsdottir O, Halfdanardottir SI, et al. Family members of cancer patients: needs, quality of life and symptoms of anxiety and depression. Acta Oncol. 2011;50:252–8.

    Article  Google Scholar 

  27. Northouse L, Williams AL, Given B, McCorkle R. Psychosocial care for family caregivers of patients with cancer. J Clin Oncol. 2012;30(11):1227–34.

    Article  PubMed  Google Scholar 

  28. Fillion L, Cook S, Blais MC, Veillette AM, Aubin M, de Serres M, Rainville F, Fitch M, Doll R, Simard S, Fournier B. Implementation of screening for distress with professional cancer navigators. Oncologie. 2011;13(6):277–89.

    Article  Google Scholar 

  29. Roth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma. Cancer. 1998;82:1904–8.

    Article  CAS  PubMed  Google Scholar 

  30. Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000;88:2164–71.

    Article  CAS  PubMed  Google Scholar 

  31. Agence de la santé et des services sociaux de la Capitale-Nationale. Direction des affaires médicales universitaires et hospitalières. Guide de formation initiale de l’infirmière-pivot en oncologie. Région de la Capitale-Nationale. 2013. http://www.ciusss-capitalenationale.gouv.qc.ca/sites/default/files/guide-de-formation-initiale-de-ipo2014-09-03.pdf. Accessed 1 July 2017.

  32. Fillion L, Cook S, Veillette AM, Aubin M, DeSerres M, Rainville F, Fitch M, Doll R. Professional navigation framework: elaboration and validation in a Canadian context. Oncol Nurs Forum. 2012;39:E58–69.

    Article  PubMed  Google Scholar 

  33. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–70.

    Article  CAS  PubMed  Google Scholar 

  34. Savard J, Laberge B, Gauthier JG, Ivers H, Bergeron MG. Evaluating anxiety and depression in HIV-infected patients. J Pers Assess. 1998;71(3):349–67.

    Article  CAS  PubMed  Google Scholar 

  35. Préville M, Boyer R, Potvin L, Perreault C, Légaré G. La détresse psychologique: détermination de la fiabilité et de la validité de la mesure utilisée dans l’Enquête Santé Québec. Québec: Ministère de la Santé et des services sociaux; 1992.

    Google Scholar 

  36. Préville M. Étude de la validité et de la fiabilité de la mesure de détresse psychologique utilisée dans l’Enquête Santé Québec. Montréal: Université de Montréal: Les cahiers du GRIS; 1995. p. T95-01.

  37. Ilfeld FW. Further validation of a psychiatric symptom index in a normal population. Psychol Rep. 1976;39:1215–28.

    Article  Google Scholar 

  38. Hileman JW, Lackey NR, Hassanein RS. Identifying the needs of home caregivers of patients with cancer. Oncol Nurs Forum. 1992;19(5):771–7.

    CAS  PubMed  Google Scholar 

  39. Dumont S, Fillion L, Gagnon P, Bernier N. A new tool to assess family caregivers’ burden during end-of-life care. J Palliat Care. 2008;24(3):151–61.

    PubMed  Google Scholar 

  40. Ferrell BR. The impact of pain on quality of life: a decade of research. Nurs Clin North Am. 1995;30(4):609–24.

    CAS  PubMed  Google Scholar 

  41. Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990;13(6):375–84.

    Article  CAS  PubMed  Google Scholar 

  42. Schag CC, Heinrich RL, Ganz PA. Karnofsky performance status revisited: reliability, validity and guidelines. J Clin Oncol. 1984;2(3):187–93.

    Article  CAS  PubMed  Google Scholar 

  43. Bowling A. Measuring disease: a review of disease-specific quality of life measurement scales. Buckingham: Open University Press; 1995.

    Google Scholar 

  44. Aarason NK, et al. The European Organisation for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Nat Cancer Inst. 1993;85(5):365–76.

    Article  Google Scholar 

  45. Miles MB, Huberman AM. Analyse des données qualitatives. 2nd ed. Bruxelles: De Boeck; 2003. p. 632.

    Google Scholar 

  46. Al W, Bakitas M. Cancer family caregivers: a new direction for interventions. J Palliat Med. 2012;15(7):775–83.

    Article  Google Scholar 

  47. Smith GF, Toonen TR. Primary care of the patient with cancer. Am Fam Phys. 2007;75(8):1207–14.

    Google Scholar 

  48. Hickner J, Kent S, Naragon P, Hunt L. Physicians’ and patients’ views of cancer care by family physicians: a report from the American Academy of Family Physicians National Research Network. Fam Med. 2007;39(2):126–31.

    PubMed  Google Scholar 

  49. Reid RJ, Coleman K, Johnson EA, et al. The group health medical home at year two: cost savings, higher patient satisfaction, and less burnout for providers. Health Aff (Millwood). 2010;29:835–43.

    Article  Google Scholar 

Download references

Acknowledgements

The authors thank the members of the IUCPQ ambulatory pulmonary oncology team, the community-based family physicians, the family caregivers and their relatives with lung cancer who participated to the pilot study that confirmed the acceptability of the multifaceted intervention being tested in this trial.

Funding

This study is supported by Le Fonds de Recherche Sante Quebec (FRSQ), Grant # 30740. The study funder had no involvement in the study design, collection, management, analysis and interpretation of data, or writing of the manuscript.

The pilot project conducted to finalize the intervention that is tested in this study was funded by infrastructure funds from the Maison Michel-Sarrazin Palliative Care and Oncology Psychosocial Research Team (ERMOS) and the Quebec Centre of Excellence on Aging.

Availability of data and materials

The research team will review all requests for data before access is granted and (where appropriate), it will be made available once the main findings of the project have been published.

Authors’ contributions

MA and LV conceived the protocol, designed and drafted the manuscript. RV, SS, JFD, LT, SD and LF participated in the design of the study. RV, SS, JFD, LT, SD, LF, MJD and PG reviewed the protocol and critically revised the manuscript for important intellectual content. All authors read and approved the final version of the manuscript.

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Not applicable.

Ethics approval and consent to participate

This study has received human ethics approval by the Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Research Ethics Committee (approval number: 2016-2523, 21206). No study procedures will be conducted without informed written consent from participants.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Author information

Authors and Affiliations

  1. Research Centre of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ), Quebec, QC, Canada

    Michèle Aubin, Lucie Vézina, Sébastien Simard & Lise Tremblay

  2. Research Centre of Primary Care and Services-Université Laval (CERSSPL-UL), Quebec, QC, Canada

    Michèle Aubin, René Verreault, Serge Dumont, Maman Joyce Dogba & Pierre Gagnon

  3. Research Centre of the CHU de Quebec, Quebec, QC, Canada

    Michèle Aubin, Jean-François Desbiens, Serge Dumont, Lise Fillion, Maman Joyce Dogba & Pierre Gagnon

  4. Department of Family Medicine and Emergency Medicine, Université Laval, Quebec, QC, Canada

    Michèle Aubin & Maman Joyce Dogba

  5. Maison Michel-Sarrazin Research Team in Palliative Care and Psychosocial Oncology (ERMOS), Quebec, QC, Canada

    Michèle Aubin, Sébastien Simard, Jean-François Desbiens, Serge Dumont, Lise Fillion & Pierre Gagnon

  6. Laval Family Medicine Unit, Université Laval, Quebec, QC, Canada

    Michèle Aubin & Lucie Vézina

  7. Department of Social and Preventive Medicine, Université Laval, Quebec, QC, Canada

    René Verreault

  8. Pulmonary Oncology Centre, IUCPQ, Quebec, QC, Canada

    Sébastien Simard & Lise Tremblay

  9. Faculty of Nursing, Université Laval, Quebec, QC, Canada

    Jean-François Desbiens & Lise Fillion

  10. Department of Medicine, Université Laval, Quebec, QC, Canada

    Lise Tremblay

  11. Faculty of Social Sciences, Université Laval, Quebec, QC, Canada

    Serge Dumont

  12. Department of Psychiatry, Université Laval, Quebec, QC, Canada

    Pierre Gagnon

  13. CIUSSS Capitale-Nationale , 2690, Chemin des Quatre-Bourgeois, Quebec, QC, G1V 0B7, Canada

    Michèle Aubin

Authors
  1. Michèle Aubin
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lucie Vézina
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. René Verreault
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Sébastien Simard
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jean-François Desbiens
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Lise Tremblay
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Serge Dumont
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Lise Fillion
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Maman Joyce Dogba
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Pierre Gagnon
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Michèle Aubin.

Additional file

Additional file 1:

SPIRIT Checklist. (DOC 122 kb)

Rights and permissions

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Aubin, M., Vézina, L., Verreault, R. et al. Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial. Trials 18, 304 (2017). https://doi.org/10.1186/s13063-017-2044-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1186/s13063-017-2044-y

Keywords

Trials

ISSN: 1745-6215