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Table 4 Overarching themes by sub-themes and participants group

From: “Nothing to lose and the possibility of gaining”: a qualitative study on the feasibility and acceptability of registry-based randomised controlled trials among cancer patients and clinicians

Overarching themes

Sub-themes

 

Cancer patients

Clinicians

Study coordinators

Recruitment and enrolment of patients in RRCTs

Facilitators

• Altruism

• Personal gain

• Trust in clinicians

Facilitators

• Benefits of RRCT study design compared to RCT “simple and straightforward”

• Equipoise

Facilitators

• Broad patient eligibility criteria

Barriers

• Limited understanding of RRCT study concept

Barriers

• Considering patients’ best interest

• Low eligible patient volume

• Competing commercially sponsored trials

• Specific research question/study design

• Perceptions of RRCT as “less exciting” than commercially sponsored RCT

Barriers

• Low eligible patient volume

• Competing commercially sponsored trials

Experiences of participating in RRCTs

• Minimal impact on patients (planning/organisation)

• Pleased with treatment and care received

• Minimal impact on clinical processes (identifying and recruiting patients, implementation and monitoring)

• “Less work” than RCTs as minimal monitoring, fewer specimens and data collection, and limited coordination required between units and departments

Recommendations for the implementation of future RRCTs

Patients

• Education

• Patients sharing their trial experiences with other eligible patients

Clinicians

• Education and increasing awareness of RRCTs

• Identifying “tractability”/“selling point” of RRCT

Hospitals

• Involving regional/rural and private hospitals to increase the patient pool and give opportunity to participate in trials

• Financial incentives for hospitals

• Building capacity and support at the sites (e.g. data entry support for clinicians)

• Regular engagement and updates from RRCT principal investigator to sites

Clinicians

• Champion clinician at each hospital site

Hospitals

• Building capacity and support at the sites (e.g. study coordinators to flag eligible patients prior to consultation)

• Coordination and support across units and departments (e.g. day oncology department and pharmacy)

• Regular engagement and updates from RRCT principal investigator to sites