A community-led intervention to enhance the recruitment and retention of Aboriginal peoples in cancer surgical trials: a mixed methods co-design study protocol

Participating in clinical trials can improve outcomes for patients with cancer. Currently, few Aboriginal peoples participate in cancer surgery clinical trials, which may lead to them missing out on potentially beneficial new treatments, and published trial data not being relevant to them. Improving the recruitment and retention of Aboriginal Australians in cancer surgical trials would enable data from Aboriginal peoples to inform clinical decision-making and subsequently enhance cancer outcomes in Aboriginal communities. This study aims to provide urgently needed information on the current barriers and enablers to participation in clinical trials, a co-designed but community-led intervention to address the main factors for non-participation and enhance those factors that encourage participation among Aboriginal people, and develop and use an appropriate framework for evaluating the feasibility and effectiveness of the intervention in the health service which can be replicated on a wider scale in Australia. This mixed-methods study will use a sequential exploratory co-design approach informed by the Consolidated Framework for Implementation Research. Stage 1 will establish a baseline evidence base through (i) community engagement and formation of an Aboriginal Advisory Committee, (ii) a scoping review of strategies to improve recruitment and retention of Aboriginal Australians in clinical trials, and (iii) a retrospective evaluation of Aboriginal participation and surgical outcomes in cancer surgical trials at a tertiary referral hospital in Sydney, Australia. Stage 2 will involve prospective qualitative data collection using culturally appropriate methods, including yarning circles and semi-structured interviews with Aboriginal patients, carers, community members, and health professionals, to identify barriers and enablers to trial participation. Stage 3 will comprise community-partnered co-design workshops to develop a culturally safe intervention. Stage 4 will pilot and evaluate the intervention using the RE-AIM framework and health economic analysis. Stage 5 will make recommendations on dissemination, sustainability, and scalability. Ethical approval for this study has been obtained from the Aboriginal Health and Medical Research Council and the Sydney Local Health District Human Research Ethics Committee. Results will be disseminated through community-approved channels, peer-reviewed publications and ​conference presentations. The intervention model will be designed for future adaptation and scalability in clinical trials and health services. Clinical trials can improve cancer care by testing new or better ways to diagnose, treat and support people with cancer. However, very few Aboriginal people in Australia currently take part in cancer clinical trials. This means their voices, experiences and needs are often missing from research that may affect them. This study works in partnership with Aboriginal communities to understand what would help make clinical trials more culturally safe and appropriate for Aboriginal people. The project is guided by an Aboriginal Advisory Committee, including members with lived experience of cancer and participating in clinical trials, that has shaped the research questions. The study has several stages. First, we will review what is already known about Aboriginal participation in cancer clinical trials. This will involve looking at past trial activity and reviewing published research on ways to improve trial recruitment. Then, Aboriginal patients, families, community members, and health workers will share their views through interviews and yarning circles. These conversations will explore experiences with research, barriers to taking part, and ideas to improve support. Next, Aboriginal community members and health professionals will work together to design better ways to explain, run and support participation in cancer clinical trials. These changes will be tested in a small number of cancer surgery trials and improved using feedback from those involved. The goal of this work is to support access to clinical trials, strengthen Aboriginal voices in research, and create a model for meaningful patient and community involvement that can be used across many specialties.