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Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study.

ABSTRACT: PURPOSE:The aim of this study was to identify patient and physician factors related to enrollment onto Gynecologic Oncology Group (GOG) trials. METHODS:Prospective study of women with primary or recurrent cancer of the uterus or cervix treated at a GOG institution from July 2010 to January 2012. Logistic regression examined probability of availability, eligibility and enrollment in a GOG trial. Odds ratios (OR) and 95% confidence intervals (CI) for significant (p<0.05) results reported. RESULTS:Sixty institutions, 781 patients, and 150 physicians participated, 300/780 (38%) had a trial available, 290/300 had known participation status. Of these, 150 women enrolled (59.5%), 102 eligible did not enroll (35%), 38 (13%) were ineligible. Ethnicity and specialty of physician, practice type, data management availability, and patient age were significantly associated with trial availability. Patients with >4 comorbidities (OR 4.5; CI 1.7-11.8) had higher odds of trial ineligibility. Non-White patients (OR 7.9; CI 1.3-46.2) and patients of Black physicians had greater odds of enrolling (OR 56.5; CI 1.1-999.9) in a therapeutic trial. Significant patient therapeutic trial enrollment factors: belief trial may help (OR 76.9; CI 4.9->1000), concern about care if not on trial (OR12.1; CI 2.1-71.4), pressure to enroll (OR .27; CI 0.12-.64), caregiving without pay (OR 0.13; CI .02-.84). Significant physician beliefs were: patients would not do well on standard therapy (OR 3.6; CI 1.6-8.4), and trial would not be time consuming (OR 3.3; CI 1.3-8.1). CONCLUSIONS:Trial availability, patient and physician beliefs were factors identified that if modified could improve enrollment in cancer cooperative group clinical trials.

SUBMITTER: Brooks SE

PROVIDER: S-EPMC4489417 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study.

Brooks Sandra E SE Carter Randy L RL Plaxe Steven C SC Basen-Engquist Karen M KM Rodriguez Michael M Kauderer James J Walker Joan L JL Myers Tashanna K N TK Drake Janet G JG Havrilesky Laura J LJ Van Le Linda L Landrum Lisa M LM Brown Carol L CL

Gynecologic oncology 20150430 1

<h4>Purpose</h4>The aim of this study was to identify patient and physician factors related to enrollment onto Gynecologic Oncology Group (GOG) trials.<h4>Methods</h4>Prospective study of women with primary or recurrent cancer of the uterus or cervix treated at a GOG institution from July 2010 to January 2012. Logistic regression examined probability of availability, eligibility and enrollment in a GOG trial. Odds ratios (OR) and 95% confidence intervals (CI) for significant (p<0.05) results rep ...[more]

PMID: 25937529

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Project description:Our purpose was to identify physicians' individual characteristics, attitudes, and organizational contextual factors associated with higher enrollment of patients in cancer clinical trials among physician participants in the National Cancer Institute's Community Clinical Oncology Program (CCOP). We hypothesized that physicians' individual characteristics, such as age, medical specialty, tenure, CCOP organizational factors (i.e. policies and procedures to encourage enrollment), and attitudes toward participating in CCOP would directly determine enrollment. We also hypothesized that physicians' characteristics and CCOP organizational factors would influence physicians' attitudes toward participating in CCOP, which in turn would predict enrollment.We evaluated enrollment in National Cancer Institute-sponsored cancer clinical trials in 2011 among 481 physician participants using Structural Equation Modeling. The data sources include CCOP Annual Progress Reports, two surveys of CCOP administrators and physician participants, and the American Medical Association Masterfile.Physicians with more positive attitudes toward participating in CCOP enrolled more patients than physicians with less positive attitudes. In addition, physicians who practiced in CCOPs that had more supportive policies and practices in place to encourage enrollment (i.e. offered trainings, provided support to screen and enroll patients, gave incentives to enroll patients, instituted minimum accrual expectations) also significantly enrolled more patients. Physician status as CCOP Principal Investigator had a positive direct effect on enrollment, while physician age and non-oncology medical specialty had negative direct effects on enrollment. Neither physicians' characteristics nor CCOP organizational factors indirectly influenced enrollment through an effect on physician attitudes.We examined whether individual physicians' characteristics and attitudes, as well as CCOP organizational factors, influenced patient enrollment in cancer clinical trials among CCOP physicians. Physician attitudes and CCOP organizational factors had positive direct effects, but not indirect effects, on physician enrollment of patients. Our results could be used to develop physician-directed strategies aimed at increasing involvement in clinical research. For example, administrators may want to ensure physicians have access to support staff to help screen and enroll patients or institute minimum accrual expectations. Our results also highlight the importance of recruiting physicians for volunteer clinical research programs whose attitudes and values align with programmatic goals. Given that physician involvement is a key determinant of patient enrollment in clinical trials, these interventions could expand the overall number of patients involved in cancer research. These strategies will be increasingly important as the CCOP network continues to evolve.

Project description:BackgroundCervical cancer screening has been effective in reducing incidence and mortality of cervical cancer, leading European countries to implement screening programs. However, migrant women show lower screening participation compared to nationals. This scoping review aims to provide a synthesis of the growing evidence on factors associated with participation in cervical cancer screening among migrant women in Europe.MethodsElectronic peer-reviewed databases were searched in November 2019 for studies on factors related to the participation of migrants in cervical cancer screening conducted in EU/EFTA countries, using comprehensive search expressions. Retrieved articles were screened and those eligible were selected for data extraction. Quantitative and qualitative studies were included. Factors were classified in barriers and facilitators and were divided into further categories.ResultsTwenty out of 96 articles were selected and analyzed. Factors associated with participation in cervical cancer screening were classified in categories related to sociodemographic, healthcare-system, psychological, migration, knowledge, language, and cultural factors. Lack of information, lack of female healthcare providers, poor language skills, and emotional responses to the test (especially fear, embarrassment and discomfort) were the most reported barriers to cervical cancer screening. Encouragement from healthcare providers and information available in migrants' languages were frequently stated as facilitators. Results on the role of sociodemographic factors, such as age, education, employment and marital status, are the most conflicting, highlighting the complexity of the issue and the possibility of interactions between factors, resulting in different effects on cervical cancer screening participation among migrant women. Several identified barriers to screening are like those to access to healthcare services in general.ConclusionsEfforts to increase migrant women's participation in CCS must target barriers to access to healthcare services in general but also specific barriers, including cultural differences about sexuality and gender, past traumatic personal experiences, and the gender and competences of healthcare professionals performing CCS. Healthcare services should strengthen resources to meet migrants' needs, including having CCS information translated and culturally adapted, as well as healthcare providers with skills to deal with cultural background. These findings can contribute to improve CCS programs among migrant women, reducing health disparities and enhancing their overall health and well-being.

Project description:ImportancePatient withdrawal of consent from a cancer clinical trial is defined as a patient's volitional cessation of participation in all matters related to a trial. It can undermine the trial's purpose, make the original sample size and power calculations irrelevant, introduce bias between trial arms, and prolong the time to trial completion.ObjectiveTo report rates of and baseline factors associated with withdrawal of consent among patients in cancer clinical trials.Design, setting, and participantsThis multisite observational cohort study was conducted through the Alliance for Clinical Trials in Oncology. Patient withdrawal was defined as a patient's voluntary termination of consent to participate anytime during trial conduct. Baseline patient- and trial-based factors were investigated for their associations with patient withdrawal within the first 2 years using logistic regression models. All patients who participated in cancer therapeutic clinical trials conducted within the Alliance for Clinical Trials in Oncology from 2013 through 2019 were included. The data lock date was January 23, 2022.Main outcomes and measuresThe percentage of patients who withdrew consent in 2 years and factors associated with withdrawal of consent.ResultsA total of 11 993 patients (median age, 62 years; 67% female) from 58 trials were included. Within 2 years, 1060 patients (9%) withdrew from their respective trials. Two-year rates of withdrawal were 5.7%, 7.6%, 8.5%, 7.8%, 8.4%, 9.5%, and 9.8% for each of the respective years from 2013 through 2019. In multivariable analyses, Hispanic ethnicity (odds ratio [OR], 1.67; 95% CI, 1.30-2.15; P < .001), randomized design with placebo (OR, 1.64; 95% CI, 1.38-1.94; P < .001), and patient age 75 years and older (OR, 1.39; 95% CI, 1.12-1.72; P = .003) were associated with higher likelihood of withdrawal by 2 years. Use of radiation was associated with patient retention (OR, 0.68; 95% CI, 0.54-0.86; P = .001).Conclusions and relevanceIn this cohort study, rates of withdrawal of consent were less than 10% and appeared consistent over time. Factors that are associated with withdrawal of consent should be considered when designing trials and should be further studied to learn how they can be favorably modified.

Project description:ObjectivesEarly phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation.DesignSemistructured interview study.SettingPatients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.ParticipantsThirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews.MethodsInterview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.ResultsMost patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility.ConclusionsThis novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.

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Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study.

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Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study.

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