By Stacey Kusterbeck
When deciding on whether to participate in a cancer clinical trial, a patient may want to help others while at the same time hoping for a cure and worrying about lack of transportation. “Understanding all of these considerations may help clinicians and researchers design clinical trials and provide resources to address participants’ immediate concerns,” says Kim Mooney-Doyle, PhD, RN, CPNP-AC, FAAN, an associate professor at University of Maryland’s School of Nursing.
Mooney-Doyle and colleagues interviewed 21 participants about why they decided to enroll in, remain in, or withdraw from cancer clinical trials.1 The qualitative descriptions were more nuanced than what can be learned from quantitative data, the researchers found.
For example, participants talked about the logistical challenges of participating in a clinical trial. At the same time, they talked about the psychological benefits of participating.
“Informed consent conversations generally focus on an adult’s autonomy and the ability to weigh the benefits and burdens of what they are being asked to participate in — a normative Western bioethics approach,” says Mooney-Doyle. The study findings suggest that research staff should go beyond that and discuss how study participation would affect the individual’s family life, finances, and logistical considerations.
A prospective participant might lack transportation on weekends, for example. If research staff can offer a solution (to either provide transportation or allow the participant to participate remotely), it could keep that study participant from withdrawing.
Other participants may need psychosocial support. This might include access to palliative care, social workers, or pastoral care. “Researchers might include psychosocial screening into study procedures, or measure health-related quality of life as a secondary outcome,” suggests Mooney-Doyle.
Participants’ physical and emotional needs often vacillate during the timeframe of the clinical trial. “It would behoove research staff to continuously check in with participants. Address any issues that might arise in the course of their participation. Ascertain whether their participation remains consistent with their preferences and goals,” says Mooney-Doyle.
When researchers design cancer study protocols, the participant “should always be front of mind,” says Christina Brennan, MD, MBA, senior vice president of clinical research at The Feinstein Institutes for Medical Research at Northwell Health. Researchers always should be thinking about ways to reduce participant burden, says Brennan. Some ways of doing this could be to offer flexible scheduling, travel, or even lodging support. Researchers could minimize the number of assessments that are required or could allow some visits to be done in the participant’s home.
“The first step in addressing the needs of participants in designing clinical trials is to identify those needs,” says Rebecca D. Pentz, PhD, the research ethics consultant at Winship Cancer Institute of Emory University. Pentz and colleagues use these approaches:
- Patient advocates and community representatives are part of the trial design team. This allows researchers to address the perspectives, cultural issues, and needs of future participants. The feedback resulted in some important changes to study protocols. For instance, some participants voiced concerns about the logistics of participating. Researchers make it possible for participants to do blood draws and urinalysis at a local clinic, arrange transport, and allow participants to do visits via telehealth if no in-person exam is needed.
- Community oncologists in rural areas have direct access to clinical trials so participants can be treated in their local clinic.
- Researchers make sure that eligibility criteria are not overly restrictive so more people are eligible to participate. The Institutional Review Board (IRB) closely examines eligibility exclusions, to make sure that each is necessary to achieve the study’s aims. “Removing unnecessary exclusions also makes the study more generalizable to the wider population,” says Pentz.
- The IRB makes sure that the study will recruit a diverse population, representative of the demographics of the study’s catchment area.
Having a diverse faculty and clinical research coordinators is also important. “We discovered that being asked to participate in a clinical trial by someone of the same race or ethnicity increases acceptance,” reports Pentz.
Reference
- Mooney-Doyle K, Knafl KA, Huang L, et al. Participants’ perceptions support the coexistence of benefits and burdens of cancer clinical trial participation. J Psychosoc Oncol. 2025;43(1):88-104.
When deciding on whether to participate in a cancer clinical trial, a patient may want to help others while at the same time hoping for a cure and worrying about lack of transportation.
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