“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

Unger, Joseph M.; Hershman, Dawn L.; Till, Cathee; Minasian, Lori M.; Osarogiagbon, Raymond U.; Fleury, Mark E.; Vaidya, Riha

doi:10.1093/jnci/djaa155

Cited by 157 publications

(127 citation statements)

References 75 publications

(46 reference statements)

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“…Despite greater odds of reported invitation to clinical trials in this study, non-Hispanic Black respondents had lower odds of reported participation in clinical trials than non-Hispanic White respondents. This contrasts with previous work showing Black and White individuals enroll in clinical trial at similar rates if invited 30,31,38,39. Although our study controlled for comorbidity status, health…”

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confidence: 90%

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

et al. 2021

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IMPORTANCE Representative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist. OBJECTIVE To examine person-level factors associated with invitation to and participation in clinical trials. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires. EXPOSURES Demographic, clinical, and health behavior-related characteristics. MAIN OUTCOMES AND MEASURES History of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior-related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models. RESULTS The median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black comparedwith non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, Նcollege degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported "health care providers" as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were "wanting to get better" (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]). CONCLUSIONS AND RELEVANCEThe findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. (continued) Key Points Question What person-level factors are associated with US adults' invitation to and participation ...

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confidence: 90%

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

et al. 2021

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“…Unger et al have recently identified this as a key distinction to acknowledge in determining demographic disparities in trial accrual rates. 33 Although our data showed that almost twice as many women than men reported that they would not necessarily participate in a research study due to COVID-19, this observation had limited statistical power and was not significant.…”

Section: Discussionmentioning

confidence: 59%

Gender Differences in Concerns About Participating in Cancer Research During the COVID-19 Pandemic

et al. 2021

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Introduction: The ongoing SARS-CoV-2 pandemic is having major effects on cancer research, including major reductions in participant accrual to cancer clinical trials. Existing research has indicated that these steep drops in accrual rates to cancer clinical trials may be disproportionately affecting women. We sought to determine if there were gender differences in a dataset collected to examine participants’ concerns about taking part in cancer research during the pandemic. Methods: Between 5-19 June 2020, we distributed a fully anonymized survey via social media. We contacted 85 UK cancer patient organizations/charities and asked them to share our questionnaire on their platforms, of which 26 obliged. Patients aged 18 with a cancer diagnosis were eligible to participate and asked about their clinical and demographic characteristics, concerns about research participation given the COVID-19 pandemic, anxiety levels measured using the Generalized Anxiety Disorder-7 (GAD-7) scale, amongst other questions. Anxiety levels and concerns about participating were compared between men and women using univariate and multivariate analyses. Results: 93 individuals, comprising n = 37 women and n = 56 men of various cancer types, provided survey responses. Independent t-tests showed that women reported higher anxiety scores, and concerns about participating in cancer research during COVID-19, than men. Linear regression analyses showed that anxiety scores predicted concerns about research participation in women but not men (pinteraction = 0.002). Conclusions: Cancer patients have concerns about participating in research during the COVID-19 pandemic that range from mild to serious. Furthermore, the relationship between general anxiety and concerns about research participation may be both more relevant and more pronounced in women than in men. Future work should examine the reasons why women are less likely to enrol in cancer trials during the COVID-19 pandemic.

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“…One key barrier to participation that has been previously identified is travel concerns (16,18). It is of concern that in our COVID-19-specific study, a crucial factor that seemed to be underlying participants' willingness to undertake inperson visits was car ownership, implying that the presence of COVID-19 may compound previously observed logistical issues related to transport.…”

Section: Discussionmentioning

confidence: 81%

“…In Viljoen et al's qualitative review, such factors included: (1) the patient's degree of trust and confidence in their healthcare professionals; (2) the style of communication of information about the trial between physician and patient (which, when suboptimal or rushed, could lead to patients feeling uninformed and alienated); (3) the sense of moral obligation, or altruism, towards society; and (4) the reassurance that they will be adequately cared for during study procedures. Further patient-level factors that may influence risk-to-benefit appraisal in this setting have been recently documented by other investigators, and these include a fear of treatment sideeffects; disliking the idea of being experimented upon; issues or complications arising from travel to the study site; burden of study procedures (including emotional burden); knowledge about the study/intervention; concerns about the physical setting of the study; and physician's attitude towards the study (14,16,18). It is conceivable that patients' considerations related to the COVID-19 pandemic may modify their experience, or appraisal, of several of these identified factors.…”

Section: Introductionmentioning

confidence: 94%

“Something Good Has to Come Out of the Horror”: A Qualitative Examination of Cancer Survivors' Attitudes Towards Participation in Research During the First Year of the COVID-19 Pandemic

Fox

Wylie

Haire

et al. 2021

Front. Public Health

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Introduction: The first year of the COVID-19 pandemic has been highly disruptive for people with cancer. Furthermore, it has been shown that accrual to cancer trials dropped substantially in 2020. Building on findings from a previous pilot survey, the present study used qualitative methods to gain insights into attitudes towards participation in research studies amongst people who have experienced cancer, in the context of the first year of the COVID-19 pandemic.Materials and Methods: We interviewed 13 participants from the UK, who were purposively sampled, including a broad sample of cancer types, and a mixture of individuals who have and have not taken part in research previously. Participants underwent semi-structured interviews (median interview duration: 47 min) and were asked open-ended questions about their attitude towards and experiences with COVID-19, and their attitude towards research participation. In addition to this, prompts were used to ask participants about concerns that were highlighted by our previous quantitative work on this topic, such as concerns about being older or having to travel to participate. Interview transcripts were analysed using a framework analysis approach.Results: Our findings suggest that cancer patient decision-making about research participation during an infectious disease pandemic may be a function of a basic cost-benefit analysis, which considers the benefit of taking part, either personally to themselves or to wider society. The benefit may then be weighed by the patient against the risk of being infected, which may be influenced by trust in the relevant clinicians/researchers; familiarity with the study location; provision of detailed information on safety protocols for infectious disease; and, in particular, the availability of safe transport to and from the study location.Discussion: Some cancer patients say that they would be less likely to participate in a research study in the middle of an infectious disease pandemic due to an increased risk to themselves. Patients' perceived risk to themselves from participating may be ameliorated via the provision of certain practical solutions that can be considered at the study protocol design stage, such as safe travel, information, and the use of staff and study sites familiar to the patient.

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“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

Cited by 157 publications

References 75 publications

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

Gender Differences in Concerns About Participating in Cancer Research During the COVID-19 Pandemic

“Something Good Has to Come Out of the Horror”: A Qualitative Examination of Cancer Survivors' Attitudes Towards Participation in Research During the First Year of the COVID-19 Pandemic

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