ABSTRACT
Background: Significant challenges exist in recruiting newly diagnosed ductal carcinoma in situ (DCIS) patients to participate in presurgical intervention trials. Perceived motivators and barriers to participation have not been formally studied from the patient or healthcare provider (HCP) perspective. Based on our experience in the Promise Study (NCT02694809), we hypothesized that delaying surgery and concern for side effects are barriers to trial participation and that access to new treatments and financial benefits are motivators. To improve recruitment, we conducted focus groups to better understand barriers and motivators for trial participation in our patient population. Methods: Three focus groups with post-menopausal women (PMW) without history of DCIS, one focus group with patients previously treated for DCIS, and two HCP focus groups were conducted. Due to COVID-19, the focus groups took place online via videoconferencing and included participants from across the United States. A thirdparty facilitator generated discussion on predetermined topics including knowledge of DCIS, clinical trial recruitment materials, hormone replacement therapy, healthcare delivery and clinical trials during COVID-19, and perceived motivators and barriers to trial participation in general and specifically for women with DCIS. Here, we focus on comparing perceived influential factors for patient participation in DCIS clinical trials in PMW and HCP focus groups. Qualitative thematic analysis was completed on focus group transcripts in NVivo. Results: PMW had no knowledge of DCIS prior to the focus groups and believed DCIS should be removed promptly. PMW believed barriers to DCIS clinical trial participation included the potential for the study drug to cause harm, distrust of medicine, and the fact that DCIS is not life-threatening. PMW identified helping future DCIS patients, accessing better treatment, and easing anxiety as motivators for DCIS trial participation. HCPs believed patients were motivated by increased monitoring by the medical team, financial incentive, and access to newer treatment. HCPs believed that delays in DCIS surgery, the potential for the intervention to be harmful or ineffective, and the trial causing patient anxiety were barriers. Neither group emphasized time commitment as a barrier to DCIS trial participation. PMW were not motivated by financial incentives. Conclusions: Knowledge about DCIS is lacking in PMW. PMW and HCPs agreed that the risk of harm caused by study interventions is a deterrent to trial participation and that access to superior treatment is a motivator. However, PMW and HCPs did not agree on other motivators and barriers which could lead to missed recruitment opportunities. Providing educational materials on DCIS and addressing motivators and barriers to clinical trial participation may increase recruitment to presurgical DCIS trials.
ABSTRACT
Background: The number of young people with mental health (MH) problems presenting in general practice and the prescribing of psychotropic medicines, particularly antidepressants have been steadily increasing over the last decade. This trend has accelerated since the onset of the COVID-19 pandemic. Objectives: To identify key issues relating to management of psychological distress, depression and anxiety disorders in people aged between 16 and 24 years. Mapping issues to behavioural change techniques and appropriate interventions to form an education programme for health professionals and young people. Methods: Desktop research, environmental scanning and interviews with consumers, health professionals, stakeholder organisations and experts in youth MH were conducted to identify issues and education themes. Interventions were informed by the Theoretical Domains Framework (Cane et al., 2012;Michie S et al., 2005) and Behaviour Change Techniques (Michie et al., 2008, 2013). Feasibility, relevance and acceptability of interventions were reviewed by health professionals, young people and other stakeholders alongside the programme scope, focus and key messages. Findings: Education themes identified for the programme include communication to empower young people to manage their MH, comprehensive assessment for young people in distress, engagement of health professionals and young people in consideration of management options, and careful review of treatment effects over time. Interventions selected include educational outreach in general practices, general practice data feedback, online articles, videos, podcasts and webinars. Conclusion: The proposed programme focuses on building young peoples' health literacy and general practitioners' knowledge, skills and confidence. It will aim to improve young peoples' experience of MH care, connections with health professionals and engagement with treatment options.