Patient communication and experiences in cancer clinical drug trials: a mixed-method study at a specialist clinical trials unit

Abstract

Background As cancer therapies increase in their complexity, effective communication among patients, physicians, and research staff is critical for optimal clinical trial management. Currently, we understand little about on-trial communication practices and patient trial experiences over time. This mixed-method study explored patient experiences of participating in a clinical drug trial at different time points, focussing on patient communication with trial staff. Methods Patients enrolled in clinical drug trials conducted at the Parkville Cancer Clinical Trials Unit were invited to complete a tailored online survey and/or a qualitative interview. Patients were recruited to three cohorts based on time since the first trial treatment: new (≥ 1 to ≤ 13 weeks), mid- (≥ 14 to ≤ 26 weeks), and long-term (≥ 52 weeks) trial patients. Descriptive statistics were calculated for survey responses. Interview data were analysed thematically with a team-based approach. Survey and interview data were integrated at the intepretation stage. Results From May to June 2021, 210 patients completed a survey (response rate 64%, 60% male), 20 completed interviews (60% male), and 18 completed both. More long-term trial patients (46%) participated than new (29%) and mid-trial patients (26%). Survey data showed high (> 90%) patient satisfaction with the provision of trial information and communication with trial staff across trial stages, and many reported trial experiences as above and beyond standard care. Interview data indicated that written trial information could be overwhelming, and verbal communication with the staff and physicians was highly valued, especially for enrolment and side effect management among long-term patients. Patients described the key points along the clinical trial trajectory that merit close attention: clear and well-communicated randomisation practices, reliable pathways for side effect reporting and prompt response from the trial staff, and end-of-trial transition management to avoid a sense of abandonment. Conclusion Patients reported high overall satisfaction with trial management but outlined key pinch points requiring improved communication practices. Establishing a range of effective communication practices among trial staff and physicians with patients in cancer clinical trials may have a wide range of positive effects on patient accrual, retention, and satisfaction.

“There was No Opportunity to Express Good or Bad”: Perspectives From Patient Focus Groups on Patient Experience in Clinical Trials

“… 10 Patients also described wanting more “plain language,” prior to enrollment, about what the trial would entail, and during the informed consent process, corroborating research describing how information about a trial can be overwhelming. 11 Our research supports how informed consent processes and understanding of risks involved in participating in clinical trial research continues to be an issue, 12 and that ultimately, trial participation and remaining in a trial is driven by patient/provider trust. 11 , 13 , 14 …”

“… 11 Our research supports how informed consent processes and understanding of risks involved in participating in clinical trial research continues to be an issue, 12 and that ultimately, trial participation and remaining in a trial is driven by patient/provider trust. 11 , 13 , 14 …”

Patient Perceptions of Care Coordination during Neoadjuvant Therapy for Gastrointestinal Cancers: A Mixed Methods Analysis

“…These findings demonstrate the importance of including discussion of these concerns during patient encounters. Patients also preferred receiving information in both verbal and written form [ 25 ]. We had hypothesized that fragmented care might be associated with CCCQ-P scores, but interestingly, no clinical, demographic, or treatment related factors were associated with quality of CCC suggesting the need for more research on optimizing care coordination.…”