Barriers and Facilitators to Adolescent and Young Adult Cancer Trial Enrollment: NCORP Site Perspectives

Background Although it is well documented that adolescents and young adults (AYAs) with cancer have low participation in cancer clinical trials (CCTs), the underlying reasons are not well understood. We utilized the NCI Community Oncology Research Program (NCORP) network to identify barriers and facilitators to AYA CCT enrollment, and strategies to improve enrollment at community-based and minority/underserved sites. Methods We performed one-on-one semi-structured qualitative interviews with stakeholders (NCORP Site Principle Investigators, NCORP Administrators, Physicians involved in enrollment, Lead Clinical Research Associates or Clinical Research Nurses, Nurse Navigators, Regulatory Research Associates, Patient Advocates) in the AYA CCT enrollment process. NCORP sites that included high- and low-AYA enrolling affiliate sites and were diverse in geography and department representation (eg, pediatrics, medical oncology) were invited to participate. All interviews were recorded and transcribed. Themes related to barriers and facilitators and strategies to improve enrollment were identified. Results We conducted 43 interviews across 10 NCORP sites. Eleven barriers and 13 facilitators to AYA enrollment were identified. Main barriers included perceived limited trial availability and eligibility, physician gatekeeping, lack of provider and research staff time, and financial constraints. Main facilitators and strategies to improve AYA enrollment included having a patient screening process, physician endorsement of trials, an “AYA champion” on site, and strong communication between medical and pediatric oncology. Conclusions Stakeholders identified several opportunities to address barriers contributing to low AYA CCT enrollment at community-based and minority/underserved sites. Results of this study will inform development and implementation of targeted interventions to increase AYA CCT enrollment.

Influencing Factors and Management of Occupational Burnout Among Clinical Research Associates in China

Objective We firstly assessed the extent and nature of occupational burnout among clinical research associates (CRAs) in China for the first time, and evaluated influencing factors in view of developing effective countermeasures. Methods CRAs were evaluated using the Maslach Burnout Inventory and a self-designed questionnaire. Detected occupational burnout was used as the index. We examined possible influencing factors of burnout using wilcoxon rank test, KW rank and Spearman correlation analysis; influencing factors were screened out with multivariate ordinal logistic regression modelling. Results Overall, 438 surveys were completed. Results indicated that 82.2% of participating CRAs had some degree of job burnout; among those, 19.9% had mild burnout, 49.8% had moderate burnout, and 12.5% had severe burnout. A total of 76.7% suffered from emotional exhaustion, 65.5% experienced depersonalization, and 15.3% felt a low sense of accomplishment. For all categories of burnout, statistically significant influencing factors were: work mode, working hours, whether the hospital provided work support and likelihood of promotion (p <0.05). Conclusion Occupational burnout was common among Chinese CRAs. To alleviate this situation and ensure the quality of clinical trials, companies and hospitals should take effective measures to establish support systems involving both hardware and software.

Barriers to minority recruitment in a multicenter clinical trial (PRO-TECT [AFT-39]): Research staff insights.

145 Background: Rates of minority enrollment in U.S. cancer clinical trials, including supportive care trials, are disproportionately low. Clinical research associates (CRAs) are the linchpin for successful accrual and often help screen and approach patients to discuss research studies. We sought to understand clinic-level factors that influence recruitment of African American patients (AA) in an ongoing U.S. multicenter, cluster- randomized controlled trial (PRO-TECT: Patient-Reported Outcomes to Enhance Cancer Treatment; NCT03249090 AFT-39]). Notably, partway through this trial, a purposeful enrollment strategy was initiated where sites were asked to focus on minority recruitment. Methods: A subset of community oncology practices participating in PRO-TECT was identified with: 1) overall patient populations ≥20% AA; or 2) <20% AA but trial enrollment ≥20% AA. Semi-structured phone interviews were conducted with CRAs at each site to elicit perceived barriers and facilitators in identifying and approaching AA patients for this trial. Results: Among 13 identified community practices out of a potential 50 randomized sites, 3 had populations <20% AA but enrollment >20% AA; 3 had populations ≥20% AA but enrollment <20% AA; and 7 had populations ≥20% AA and enrollment >20% AA. All sites identified participants through review of clinic visit lists with clinicians. Eleven out of 13 sites felt they experienced no barriers to identifying, approaching, or enrolling minority patients. One site CRA felt minority patients are often “too sick to participate”. One CRA felt awkward about the request to purposefully approach minority patients. Conclusions: Site CRAs generally did not perceive barriers to minority recruitment, even when their population demographics were underrepresented in accrual. Results of efforts in this trial to increase minority participation through a purposeful enrollment strategy will be reported elsewhere.

Comorbidities and related factors in rheumatoid arthritis patients of south India- Karnataka Rheumatoid Arthritis Comorbidity (KRAC) study

The aim was to study the prevalence of comorbidities in rheumatoid arthritis (RA) patients in everyday clinical practice and their association with disease-specific and demographic factors. The multi-center study recruited 3,247 (at 14 centers, and 265) were excluded due to incomplete data. The number of subjects considered for the analysis was 2982. The mean (±standard deviation) age was 48.98±12.64 years and the male-to-female ratio was 1:5. The data was collected based on a pre-structured pro forma by trained clinical research associates through interview and verification of charts and reports available in the patient records. The following comorbidities were studied: cardiovascular disease, hypertension, diabetes mellitus, hypercholesterolemia, thyroid disease, psychiatric diseases like depression, and pulmonary disease. Hypertension (20.7%), diabetes mellitus (14.4%) and thyroid disease (18.3%) were the most prevalent comorbidities. Hypercholesterolemia (5.3%), pulmonary diseases (2.1%), cardiovascular diseases (0.2%) and depression (0.03%) were prevalent in ≤5% of the study population. The overall presence of comorbidity increased with age and reduced with the duration of illness prior (DOIP). The age, gender, and DOIP differed significantly between groups with and without hypercholesterolemia. Females had a statistically increased prevalence of thyroid disease. The prevalence of comorbidities in RA patients from south India is around 40% and the incidence of comorbidity increased with age. As per the literature evidence, the prevalence in the current study subjects was higher when compared to prevalence of similar diseases occurring in the general south Indian population.

ASCO's Community Research Forum: Addressing Challenges of Community-Based Research from the Grass Roots

ASCO's Community Research Forum is a solution-oriented venue for community research sites to overcome barriers to conducting clinical trials. The key objectives of the Forum are to (1) convene community-based researchers to identify challenges to conducting research that ASCO can address, (2) develop solution-oriented projects to address these challenges to facilitate clinical trial participation in community research settings, and (3) shape ASCO programs and policies to support members engaged in community research. The Community Research Forum holds an annual in-person meeting that convenes physician investigators, research administrators, research nurses, and clinical research associates from community-based research programs and practices. To meet identified needs, the Community Research Forum has developed the ASCO Clinical Trial Workload Assessment Tool and the ASCO Research Program Quality Assessment Tool. Both of these tools will be available to the public in 2014. The Forum is currently exploring the concept and potential metrics of a research certification program to formally assess community-based research programs, and to identify gaps and areas to improve the program in order to meet quality standards. The Community Research Forum's website aims to serve as a go-to resource for community-based physician investigators and research staff. The Community Research Forum will continue to provide a forum for community-based researchers to network, share challenges, and develop initiatives that provide solutions and facilitate the conduct of clinical trials.