Tina Zhang, Nina Modanlo, David Li, Kiana Mahdaviani, N. Ko
{"title":"Abstract PO-085: A mixed-methods study of minority recruitment for cancer genomics research at a large urban safety net hospital","authors":"Tina Zhang, Nina Modanlo, David Li, Kiana Mahdaviani, N. Ko","doi":"10.1158/1538-7755.disp21-po-085","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-po-085","url":null,"abstract":"","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127871278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeanne M. Regnante, Lola Fashoyin-Aje, E. Sonet, Quita Highsmith, M. Gonzales, Sandra Amaro, A. Davis, M. Murray, Maimah Karmo, Barbara E. Bierer
{"title":"Abstract PO-084: The pharmaceutical industry in action: 2021 clinical research diversity and inclusion survey","authors":"Jeanne M. Regnante, Lola Fashoyin-Aje, E. Sonet, Quita Highsmith, M. Gonzales, Sandra Amaro, A. Davis, M. Murray, Maimah Karmo, Barbara E. Bierer","doi":"10.1158/1538-7755.disp21-po-084","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-po-084","url":null,"abstract":"Development of medicines and vaccines for COVID-19 amplified the need for all US communities to participate in research. This recognition spurred interest in adopting inclusive and equitable research practices across industry and the clinical research ecosystem in general. Between 2018-2021, regulatory bodies, professional organizations, and working groups issued policy and/or recommendations outlining measures that support the conduct of inclusive and equitable clinical trials. We applied previously published multi-themed strategies, multi-stakeholder recommendations, and calls to action by surveying industry to document baseline practices towards equitable clinical trial representation in the US. Research Question: What strategies are industry leaders deploying to increase diversity in clinical trials? Methods: Using a 4-staged approach, we first identified 48 success factors sourced from 12 documents. This analysis included previously documented measures that are both inclusive of diverse populations as well as practices that facilitate insights from diverse communities. Second, a survey tool was developed that organized the individual success factors into 6 categories with one open-ended question on ecosystem changes;survey measures and 4 choices for each factor were “Actively implementing,” “Recommended to be implemented,” “No plans to implement,” and “No answer.” Third, the survey was administered between April 10-30, 2021, to 12 pharmaceutical companies all having a proven external commitment to health equity in oncology and all are represented on the 2021 1Q Biopharma top 25 by Market Cap report. Fourth, responses were anonymized and aggregated;results were provided to respondents. Results: The response rate was 67% (8/12). Responders indicated success factors across two major implementation categories as follows: “actively implemented” (51%);“recommended/planned for implementation” (44%). No responders added any additional success factors via free text. Being “actively implemented” was highest for the 3 categories “site selection” (78%), “general capabilities” (72%), “leadership” (53%). “Recommended/planned for implementation” was highest for the 3 categories “participant focused” (50%), “other factors” (50%), “racial and ethnic minority group data (REMG)” (48%). Conclusions: Pharmaceutical companies reported active implementation of success factors sourced from public documents across all categories. As an example, stakeholders have generally considered thoughtful site selection an important measure to enroll diverse representation in clinical trials as it may mitigate access barriers to participation. In the site selection category, the survey reported 7/8 companies were actively implementing three measures and 5/8 were actively implementing two measures. An approach and analysis should be considered for expansion to more biotech companies and include a process devised for annual fielding and transparently reporting results.","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116224540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hayley M. Dunlop, Evelyn Fitzpatrick, Kevin Kurti, S. Deeb, Erin Gillespie, F. Chino, L. Dover, C. Estilo, C. J. Tsai
{"title":"Abstract PR-05: Worsening disparities of racial minority participation in phase 1 early drug development trials in the United States, 2001-2018","authors":"Hayley M. Dunlop, Evelyn Fitzpatrick, Kevin Kurti, S. Deeb, Erin Gillespie, F. Chino, L. Dover, C. Estilo, C. J. Tsai","doi":"10.1158/1538-7755.disp21-pr-05","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-pr-05","url":null,"abstract":"","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123860615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P. Chalela, E. Muñoz, Vivian Cortez, A. Flores, P. Sukumaran, C. Despres, D. Inupakutika, D. Akopian, A. Ramirez
{"title":"Abstract PO-082: Improving adherence to hormone therapy among breast cancer patients through a mobile app and patient navigation: Preliminary results","authors":"P. Chalela, E. Muñoz, Vivian Cortez, A. Flores, P. Sukumaran, C. Despres, D. Inupakutika, D. Akopian, A. Ramirez","doi":"10.1158/1538-7755.disp21-po-082","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-po-082","url":null,"abstract":"Background: The successful use of hormone therapy (HT) has contributed to improved 5-year cause-specific breast cancer survival rates, and evidence shows that long-term use produces a larger reduction in recurrence and mortality, with nearly 50% reduction in breast cancer mortality during the second decade after diagnosis. Despite the proven benefits, hormone therapy adherence is suboptimal (less than 80% of daily doses taken), and about 33% of women who are prescribed HT do not take their medication as prescribed and are at increased risk of disease recurrence and increased mortality. Smartphone ownership has increased substantially over the past decade, providing an extraordinary opportunity for innovation in the delivery of tailored interventions to improve patients' adherence to hormonal therapy. Purpose: We present preliminary results of a pilot study that involves a theory-based, culturally tailored, interactive mobile app + patient navigation to improve adherence to HT among breast cancer patients attending the breast clinic at the Mays Cancer Center (MCC). Methods: This is a 2-group parallel, randomized control trial that is currently recruiting 120 breast cancer patients and randomly assigning them to the intervention (60) or the control (60) group. The intervention group receives two components: 1) the HT Helper phone app;and 2) assistance from a patient navigator who will provide educational, psychosocial support and reinforcement, address common barriers, and facilitate the interaction with the medical team as needed. The control group receives the usual care and information provided by the MCC's breast clinic to patients undergoing HT. The app and navigation support are based in Social Cognitive Theory and principles of motivational interviewing. Results: Due to the COVID-19 pandemic, we were forced to suspend the start of the intervention until May 2021. We have recruited 27 patients and will present a general description of participants and preliminary results of the 3- month follow-up. This theory-based intervention will empower patients' self-monitoring and management. It will facilitate patient education, identification/reporting of side effects, delivery of self-care advice, and simplify communication between the patient and the oncology team. Conclusions: The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using HT and other oral anticancer agents. The ultimate goal of this innovative multi-communication intervention is to improve overall survival and life expectancy, enhance quality of life, reduce recurrence, and decrease healthcare costs.","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"112 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117252600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P. Adsul, Karen Quezada, Katie E Myers, Talya Jaffe, B. Tawfik, Emily Wu, M. Mcclain, Shiraz I. Mishra, Miria Kano
{"title":"Abstract PO-080: Reaching the “hard to reach” sexual and gender diverse communities for population-based research in cancer prevention","authors":"P. Adsul, Karen Quezada, Katie E Myers, Talya Jaffe, B. Tawfik, Emily Wu, M. Mcclain, Shiraz I. Mishra, Miria Kano","doi":"10.1158/1538-7755.disp21-po-080","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-po-080","url":null,"abstract":"","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130296379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ashithkumar Beloor Suresh, Subecha Dahal, Christopher E. Gantz, A. López
{"title":"Abstract PO-081: Cancer clinical trial access during the COVID-19 pandemic","authors":"Ashithkumar Beloor Suresh, Subecha Dahal, Christopher E. Gantz, A. López","doi":"10.1158/1538-7755.disp21-po-081","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-po-081","url":null,"abstract":"Introduction: Cancer clinical trial conduction during the COVID-19 pandemic required a rapid move to virtual engagement to support participant and research team safety. We were faced with the challenge of translating our approach from in-person to virtual engagement for recruitment, enrollment, and delivery of the study intervention. We present our strategies to conduct cancer clinical trials focused on cancer risk reduction during the COVID-19 pandemic. Subject Recruitment: Our multimodal approach utilized online platforms and established approaches like posters, flyers, and collaborating with community health workers to recruit participants. Our virtual engagement strategies include direct outreach to potential participants via email, the electronic medical record (EMR), and social media. Contact via email and the EMR was guided by study-defined eligibility criteria. Social media outreach was through institutional Twitter, Facebook, and video channel accounts. Twitter posts and chats were employed. Enrollment: e-consenting and remote consenting processes were instituted via REDCAP. Delivery of the Educational Risk Reduction Intervention: We also conducted the intervention using the Zoom platform and through a recorded video of the educational risk reduction intervention, which is shared with the participant via REDCAP. Challenges: As documented by others, the greatest challenge to virtual engagement is lack of internet access and lack of digital literacy. These factors have a greater impact on underserved populations, including the elderly, those with low socioeconomic status, those located farther from the cancer center, and racially/ethnically diverse populations. Conclusion: By translating study outreach and processes to virtual engagement, we were able to facilitate clinical trial access across diverse community subgroups and support subject participation in clinical trials during the COVID-19 pandemic.","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116035081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Abstract PO-083: Descriptive pilot study results of belief in research, religious coping, and willingness to participate in clinical trials among African Americans with hematologic malignancies","authors":"Marjorie Petty","doi":"10.1158/1538-7755.disp21-po-083","DOIUrl":"https://doi.org/10.1158/1538-7755.disp21-po-083","url":null,"abstract":"","PeriodicalId":437075,"journal":{"name":"Behavioral and Social Science: Recruitment/Retention/Adherence Research","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115016748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}