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Association of Perceived Benefit or Burden of Research Participation With Participants' Withdrawal From Cancer Clinical Trials. | LitMetric

AI Article Synopsis

  • - The study investigates how patients’ perceptions of benefits and burdens influence their decision to stay in cancer clinical trials (CCTs), highlighting the importance of participant retention to avoid biases and data loss in research.
  • - Conducted at a comprehensive cancer center, the research involved a survey of 334 adult cancer patients from September 2015 to June 2019, assessing their views on 22 benefits and 23 burdens of trial participation using a 5-point scale.
  • - Results showed that key benefits included helping others and societal contribution, while notable burdens were concerns about placebos and adverse effects, with higher burden perceptions linked to increased withdrawal rates from the trials.

Article Abstract

Importance: Attrition in cancer clinical trials (CCTs) can lead to systematic bias, underpowered analyses, and a loss of scientific knowledge to improve treatments. Little attention has focused on retention, especially the role of perceived benefits and burdens, after participants have experienced the trial.

Objectives: To examine the association between patients' perceived benefits and burdens of research participation and CCT retention.

Design, Setting, And Participants: This survey study was conducted at a National Cancer Institute-designated comprehensive cancer center in the Northeast region of the US. The sample included adult patients with a cancer diagnosis participating in cancer therapeutic trials. Data were collected from September 2015 to June 2019. Analysis of study data was ongoing since November 2019 through October 2022.

Exposures: Self-reported validated survey instrument with a list of 22 benefits and 23 burdens of research participation that can be rated by patients with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).

Main Outcomes And Measures: A primary outcome was actual withdrawal from the CCT, and a composite outcome was composite withdrawal that included both actual withdrawal and thoughts of withdrawing. Bivariate and multivariable logistic regressions were used.

Results: Among the 334 participants in the sample, the mean (SD) age was 61.9 (11.5) years and 174 women (52.1%) were included. Top-cited benefits included both aspirational and action-oriented goals, including helping others (94.2%), contributing to society (90.3%), being treated respectfully (86.2%), and hoping for a cure (86.0%). Worry over receiving a placebo (61.3%), rearranging one's life (41.9%), and experiencing bothersome adverse effects (41.6%) were notable burdens. An increased burden score was associated with a higher probability of actual withdrawal (adjusted odds ratio [OR], 1.86; 95% CI, 1.1-3.17; P = .02) or composite withdrawal (adjusted OR, 3.44; 95% CI, 2.09-5.67; P < .001). An increased benefit score was associated with lower composite withdrawal (adjusted OR, 0.40; 95% CI, 0.24-0.66; P < .001). For participants who reported the benefits as being equal to or greater than the burdens, 13.4% withdrew. For those who perceived the benefits as being less than the burdens, 33.3% withdrew (adjusted OR, 3.38; 95% CI, 1.13-10.14; P = .03). The risk of withdrawal was even higher for the composite outcome (adjusted OR, 7.70; 95% CI, 2.76-21.48; P < .001).

Conclusions And Relevance: This survey study found that patients perceived important benefits from CCT participation, and this perception was associated with trial retention, even among those who also perceived substantial burdens. A broader dialogue among stakeholders can inform an ethical and patient-centric focus on benefits throughout the course of a CCT to increase retention.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713607PMC
http://dx.doi.org/10.1001/jamanetworkopen.2022.44412DOI Listing

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