At-risk patient and healthcare provider perspectives on clinical trial participation for ductal carcinoma in situ.
Authors: Adams Elizabeth , Kulkarni Swati , Zheng Veronica , Warwar Samantha Ahsan , Brown Denisha , Schulte Lauren , Cooper Robin , Labomascus Bazil , Bhavsar Erica B. 
Published: June 2022

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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 third-party 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. Clinical trial information: NCT02694809.