Biospecimen Donation Research Articles

Abstract A110: The CaRE2 health equity center Contact Registry: Engaging underrepresented community participants in cancer research

Abstract Background: One of the most common barriers in community participant engagement in cancer research is lack of information, and at times, not being invited to participate. Contact Registries serve as a valuable tool to address this challenge, as they connect community members with cancer health research opportunities. Potential participants can choose to participate in studies they find of interest and are prime candidates for. The Florida-California Cancer Research, Education, and Engagement (CaRE2) Health Equity Center, Community Outreach Core (COC), developed a contact registry designed to engage Black/African American (B/AA) and/or Hispanic/Latinos/a (H/L) individuals in ongoing research studies conducted across our bicoastal center institutions which includes the University of Southern California Norris Comprehensive Cancer Center, the University of Florida, and the Florida Agricultural & Mechanical University. The CaRE2 Contact Registry was implemented in August 2022 by the CaRE2 COC, with the primary objective to increase the number of underrepresented minority individuals participating in cancer research. Methods: Individuals are recruited into the registry utilizing both in-person and online methods. Information is provided in English and Spanish, and data is stored on REDCap. For in-person enrollment, a consent form and OPT-IN survey is completed; our online recruitment utilizes additional screening questions to ensure eligibility. The COC in Florida and Los Angeles promote the registry at local community events and through social media accounts and website (https://care2healthequitycenter.org/the-care2-contact-registry/). A $10.00 physical or electronic gift card is provided as compensation. Results: As of April 30th, 2024, 1,328 individuals have enrolled in the Registry, with participants from FL (887 = 69.5%) and CA (389 = 30.5%); with 737 participants being B/AA (57.8%), 506 H/L (39.7%), 26 non-Hispanic White (2.0%), and 6 individuals self-identified as other race/ethnicity (0.5%). We enrolled 873 female (68.5%) and 402 male (31.5%) participants. A total of 90.4% of enrollees are willing to participate in health research involving surveys, 23% in health research studies requiring saliva (24.1%), hair (23.4%), or blood (22%) sample donations. When registrants were asked for future research interest 99.9% responded Yes. Conclusion: Community participants have a high interest in engaging in research studies regardless of race/ethnicity if its via surveys, attending focus groups, and/or joining community forums. There is greater hesitancy when asked to provide biospecimens (blood, hair or saliva). Mechanisms to understand the reasons for this hesitancy, and address them, to appropriately incentivize individuals about donation of biospecimens are needed. Community efforts that connect potential enrollees to cancer studies of interest can support increased participation in cancer research among B/AA and H/L communities. Citation Format: Carolina Aristizabal, Eduardo Ibarra, Fern Webb, IIeana Guzman, Brooke Hensel, John Luque, Rosa Barahona, Diana Wilkie, Mariana C Stern, Sandra Suther, Lourdes Baezconde-Garbanati. The CaREhealth equity center Contact Registry: Engaging underrepresented community participants in cancer research [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A110.

Exploring biorepository donation patterns, experiences, and recommendations: a mixed-methods study among Appalachian adults enrolled in a sugary drink reduction program.

Under-represented subgroups in biomarker research linked to behavioral health trials may impact the promise of precision health. This mixed methods study examines biorepository donations across an Appalachian sample enrolled in a sugary drink reduction intervention trial. Participants enrolled in the behavioral trial were asked to join an optional biomarker study and were tracked for enrollment and biospecimen returns (stool and/or buccal sample). At 6 months, participants completed a summative interview on decision-making process, experiences collecting samples, and recommendations to encourage biospecimen donation. Return rates were analyzed across demographics (i.e., age, gender, race, education, income, health literacy status, and rurality status) using chi-squares. Qualitative data were content coded with differences compared by biomarker study enrollment and donation choices. Of the 249 invited participants, 171 (61%) enrolled, and 63% (n = 157) returned buccal samples and 49% (n = 122) returned stool samples. Metro residing participants were significantly more likely (56%) to return stool samples compared to non-metro (39%) counterparts [x2(1) = 6.61; p = 0.01]. Buccal sample return had a similar trend, 67 and 57%, respectively for metro vs. non-metro [x2(1) = 2.84; p = 0.09]. An additional trend indicated that older (≥40 years) participants were more likely (55%) to donate stool samples than younger (43%) participants [x2(1) = 3.39; p = 0.07]. No other demographics were significantly associated with biospecimen return. Qualitative data indicated that societal (66-81%) and personal (41-51%) benefits were the most reported reasons for deciding to donate one or both samples, whereas mistrust (3-11%) and negative perceptions of the collection process (44-71%) were cited the most by those who declined one or both samples. Clear instructions (60%) and simple collection kits (73%) were donation facilitators while challenges included difficult stool collection kits (16%) and inconveniently located FedEx centers (16%). Recommendations to encourage future biorepository donation were to clarify benefits to science and others (58%), provide commensurate incentives (25%), explain purpose (19%) and privacy protections (20%), and assure ease in sample collection (19%). Study findings suggest the need for biomarker research awareness campaigns. Researchers planning for future biomarker studies in medically underserved regions, like Appalachia, may be able to apply findings to optimize enrollment.

"Lord Knows What's Being Done with My Blood!": Black Women's Perceptions of Biospecimen Donation for Clinical Research in the United States.

Black women are underrepresented in clinical research and clinical trials. Knowledge gaps lead to biased clinical practice and care. There is a small but growing body of literature on Black women's perceptions about participation when biospecimen donation is sought by researchers. This is the first known study to investigate willingness to participate in clinical research involving biospecimen donation among Black women of reproductive age in the United States. This cross-sectional study recruited 496 Black women (ages 18-49) from a research crowdsourcing platform. Participants completed a 46-item online survey which asked about their willingness to provide blood samples for clinical health research and reasons for their willingness or for any unwillingness. Descriptive statistics and thematic analysis method were used to analyze the data. Less than half (44%) of participants reported willingness to provide blood samples for clinical research. The most common concerns of those expressing unwillingness to provide samples were "fear of blood sample being misused" and "distrust with the health researchers handling the samples." We identified six qualitative themes from the analysis of participants' open-ended responses. The most important factors include a desire for integrity and transparency in research, institutional racism contributing to mistrust, and adequate compensation and clearly defined benefits to participation. The recruitment and engagement of Black women in clinical biospecimen research should involve transparent, trustworthy, and anti-racist practices and informed respect for Black women's autonomy. There is a need to address Black women's concerns about exploitative profits and mistrust of academic and medical institutions.

Attitudes of oncology patients’ towards biospecimen donation for biobank research

BackgroundSince the biological material that remains after diagnostic and therapeutic procedures plays crucial role in biobank research, this study aims to explore cancer patients’ views on the donation of biospecimens for research purposes.Methods548 oncology patients from two hospitals with oncology treatment units in Poznan, Poland, completed an anonymous, self-administered pen-and-paper questionnaire.ResultsAlthough only 43.4% of patients had heard of biobanks, 93.1% declared themselves willing to donate. 71.1% of patients believed that doctors should ask patients to donate, and 60.9% that this should be done before the medical procedure. While 65% of patients were willing to donate any type of tissue that remained after a medical procedure, blood, saliva and hair were indicated most frequently. 40.5% of patients would donate their entire body after death and 21% would refuse. Patients’ support for biobanks was mainly driven by the desire to support science, help advance cancer research and altruism. Some respondents expected health information or medical treatment. The most common barriers for donation were physical distance, repeated examinations, concerns over the privacy and confidentiality of data and the commercial or unethical use of samples. Patients’ attitudes toward biobank donation seemed to be associated with age, education level, declared religiousness, a family history of genetically determined diseases and whether they were a blood donor.ConclusionsAlthough cancer patients’ lack of biobank awareness had no effect on their affirmative attitudes towards biobank research, there is a need to further increase patients’ support and overcome possible barriers that might hinder their willingness to donate.

Abstract 2159: Testing of an educational tool kit for the Community Genetic Navigation Engagement Specialists, COGENES, Training Program

Abstract Introduction: There is a lack of culturally sensitive materials to educate the Hispanic/Latino/a/x (H/L) community on colorectal cancer (CRC), which is the second and third leading cause of cancer deaths among H/L men and women in the United States, respectively. For these reasons, an Educational Tool Kit was created for the Community Genetic Navigation Specialists (CoGENEs) program at the Center for Optimizing Engagement of Hispanic Colorectal Cancer Patients in Cancer Genomic Characterization Studies (COPECC) at the University of Southern California (USC). CoGENES is a train the trainer program geared towards the development of a local workforce of trained community engagement specialists, promotores de salud (community health workers) that will act as liaison agents to increase knowledge and create community awareness on genetic research, clinical genetic testing, counseling, biospecimen donation and participation in clinical trials for H/Ls CRC patients, and community at large. Methods: The Tool Kit consisted of a newly developed educational handbook focused on CRC prevention, genetics, counseling, tumor testing, and patient navigation, as well as existing materials with resources for CRC and counseling. To test the handbook, five focus groups in Spanish/English were conducted with 44 participants, recruited via community agencies/clinics serving Los Angeles. Optimization probes focused on readability, knowledge, acceptability, barriers, and recommended changes. Content analysis was conducted with focus group transcripts to inform how to optimize the handbook. A Materials Review Optimization Scorecard was developed to evaluate materials on content, literacy, graphics, layout and typography, learning, stimulation and motivation, and cultural and language appropriateness. Fifteen pieces in the handbook were each rated by three community health workers. A final suitability score was calculated for each piece. Results: Overall, the materials were well received, and participants understood the overall main message of the materials. Feedback included refining terminology, providing additional headings and subtitles, and clarifying images to optimize the illustration of mutations. Final suitability scores from community health educators ranged from 80 to 99% for all materials, translating into “superior materials.” Conclusion: Overall materials were well received, and they were rated as “superior materials.” Participants’ feedback from CoGENES is shared with the Engagement Optimization Unit (EOU) and Patient Engagement Unit (PEU) to optimize ongoing education and research at COPECC. The MR-OS tool will be shared with other PEU’s at other center’s to encourage it use when developing educational materials. Citation Format: Yaneth L. Rodriguez, Janet Rodriguez, Charité Ricker, Julie Culver, Daisy Hernandez, Natalia Guierrez, Yvonne Cardona, Rosa Barahona, Bianca Rosales, Mariana Stern, Lourdes A. Baezconde-Garbanati. Testing of an educational tool kit for the Community Genetic Navigation Engagement Specialists, COGENES, Training Program [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2159.

Abstract 1003: Contact registry for health-related cancer research: Promoting inclusion in research

Abstract Contact Registries can serve as key tools in connecting community members to cancer health research opportunities. Members of underrepresented groups who enroll in a contact registry can choose to participate in studies they find interesting, provided they are an ideal candidate for participation. However, limited information exists regarding the types of studies underrepresented groups would want to participate in. The Florida-California Cancer Research, Education, and Engagement (CaRE2) Health Equity Center Community Outreach Core (COC) created a contact registry of community members self-identifying as Black/African American (B/AA) and/or Hispanic/Latinx (H/L) persons who are interested in learning about future research studies conducted at CaRE2 institutions. The CaRE2 Contact Registry was implemented in August 2022 by the CaRE2 COC, one of the six (6) key cores within the CaRE2 Center. COC’s primary objective is to increase the number of persons participating in cancer research, which ultimately produces findings more applicable to the broader, diverse population of B/AA and H/L communities in both Florida and California. Our study team promotes the registry at local community events and through our center’s social media accounts and website (https://care2healthequitycenter.org/the-care2-contact-registry/). Recruitment consists of both in-person and online methods provided in both Spanish and English with data stored on REDCap, an online data repository system. For in-person enrollment, a consent/authorization form and OPT-IN survey are completed; meanwhile, our online recruitment requires additional screening to ensure eligibility. Eligibility requires that the person resides in 1) either California or Florida, 2) be 18+ years old, and 3) identify as B/AA or H/L. In addition to collecting contact and demographic information, participants can choose their research study interests. For example, they can choose to participate in surveys, community forums, focus groups, a cancer advocacy training program, and/or to provide a hair, saliva, or blood sample. A $10.00 gift card, either in a physical or electronic format, was provided to each confirmed enrollee. As of November 13, 2023, 1,269 persons have enrolled, representing 63% of the 2,000 enrollment goal. While 92% of registry enrollees are willing to participate in health research involving surveys, only 20% are willing to participate in health research studies requiring saliva (23%), hair (22%), or blood (20%) donations. In conclusion, registry enrollees, regardless of race or ethnicity, have a high interest in participating in studies involving completing surveys or attending focus groups. However, efforts must continue to increase participation willingness for research involving biospecimen donation. Future efforts will also include connecting enrollees to cancer health-related research studies of their interest. Citation Format: Fern Webb, IIeana Guzman, Brooke Hensel, Eduardo Ibarra, Carolina Aristizabal, John Luque, Rosa Barahona, Diana Wilkie, Mariana C. Stern, Lourdes Baezconde-Garbanati, Sandra Suther. Contact registry for health-related cancer research: Promoting inclusion in research [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1003.

Our needs have been ignored for a long time: Factors affecting willingness of Black and Hispanic/Latinx sexual and gender minority communities to donate biospecimens.

The study aimed to document factors affecting willingness to engage in biospecimen donation for substance use research among Black and Hispanic/Latinx sexual and gender minority (SGM) people. From May to July 2022, we interviewed 22 Black and Hispanic/Latinx SGM people from The PRIDE Study, a cohort of SGM people in the United States and its territories, using Zoom videoconferencing software. Fourteen participants were sexual minority people, and eight participants were gender minority people. We took an inductive, collaborative qualitative analytic approach to identify themes. Themes included: (1) community benefits, (2) personal benefits, (3) community exploitation, (4) personal risks, (5) convenience, (6) trustworthiness of the research team, (7) perceived value in donating, and (8) normalization of biospecimen collection. Participants were generally motivated to engage in biospecimen donation for altruistic purposes. The most cited concerns were related to data security, misuse, and privacy. Researchers must be proactive in building trust with Black and Hispanic/Latinx SGM communities to increase engagement, diversify biospecimen repositories and reduce health inequities. Future research involving biospecimens should provide biospecimen education during the consent process and prioritize participant convenience.

Abstract A011: Evaluation of a theory-informed video intervention to educate underrepresented groups on clinical and genomic research using the Theoretical Framework of Acceptability

Abstract Introduction: Emerging evidence supports the potential effectiveness of technologically based interventions to disseminate health information to underserved populations. Considering the multifactorial barriers to clinical trial and genomic testing participation especially for African Americans (AA), who have been shown to make up less than 10% of all cancer clinical trial participants, a video was developed to inform minority populations on the importance of diversity in clinical trials and genomic research. To confirm that the video was deemed acceptable by the target audience, a quantitative assessment was conducted. Methods: We utilized the Theoretical Framework of Acceptability to create a survey aimed at assessing the animated video. Participants viewed the video and were asked to fill out the survey. Thirty-seven surveys were completed which included members of a patient advisory council at a local hospital (n=6) and graduate students from a medical school (n=29). Results: Responses were recorded on a five-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Participants agreed that they enjoyed viewing the illustrations in the video (𝑋̅=4.32, s=0.97) and listening to the audio (𝑋̅=4.22, s=1.03). After watching the video, participants reported that it educated them on what a “genome” is (𝑋̅=4.16, s=0.83), as well as the benefits of participating in a clinical trial (𝑋̅=4.62, s=0.49) and donating biospecimens (𝑋̅=4.14, s=0.95). Participants moderately agreed that the video informed them on the disadvantages of participation in a clinical trial (𝑋̅=3.38 s=1.36) and biospecimen donation (𝑋̅=3.70, s=1.10). Participants reported feeling confident in making well-informed decisions about participating in clinical trials (𝑋̅=4.27, s=0.69) or donating biospecimens after watching the video (𝑋̅=4.24, s=0.80). However, after watching the video participants reported being somewhat unclear on how to sign up for a clinical trial (𝑋̅=3.57, s=1.21) and how to donate biospecimens (𝑋̅=3.43, s=1.21). Overall, the video was inclusive of the participants’ beliefs and values (𝑋̅=4.24, s=0.76) and attitudes towards the video were favorable with a mean score of 4.4 (s=0.62) on a scale from 1 (Completely Unacceptable) to 5 (Completely Acceptable). Discussion: The feedback received through the TFA adapted questionnaire will be utilized to improve the content of the video. Health communication methods should consider creating technologically based interventions that are deemed acceptable by target populations, in order to engage with and educate underrepresented populations. Citation Format: Victoria Churchill, Jamirah Y. Chevrin, Roland Matthews, Brian Rivers. Evaluation of a theory-informed video intervention to educate underrepresented groups on clinical and genomic research using the Theoretical Framework of Acceptability [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A011.

Patients' views on HCC biospecimen research: Understanding the role of race and culture through interviews.

HCC is a leading cause of cancer-related mortality; there are significant racial and ethnic disparities in HCC risk and survival. Our knowledge regarding whether molecular and genetic factors contribute to these observed differences is limited by scarcity of biospecimens, which are especially scarce in minority populations. Because biospecimens are not needed for HCC diagnosis or treatment, patients are less likely to provide biospecimens solely for research purposes. We identified participants, n = 32, from an ongoing prospective cohort study. Using semi-structured interviews, we examined perceptions of providing biospecimens for research to identify factors that motivate and hinder their willingness to donate. Directed content analysis resulted in 6 themes, including reported experiences of (1) support or suspicion in donating biospecimens; (2) desire to help others or themselves; (3) inconvenience, discomfort, and concerns about privacy or recovery as hindrances to donating; (4) recommendations for health care researchers; (5) preferences for biospecimen donation; and (6) the influence of race, culture, and religion in donating biospecimens. Patients reported being least willing to donate specimens that required more invasive procedures and recovery, namely, liver tissue. Patients reported being more likely to donate if the data collection was convenient, resulted from discarded tissue, or was instituted as part of a broad opt-in consent approach, with assurances as to confidentiality and prosocial benefit. Participants expressed mixed views about whether race and culture influence people's willingness to donate biospecimens. Specific recommendations to increase the likelihood of donation include providing patients with educational materials addressing the benefits of donation and the concerns about confidentiality and data usage, making donation convenient, and adopting a broad consent bio-banking policy.

Abstract 5534: “Simply ask and explain”: perspectives from Black patients with lung cancer on strategies to address racial disparities in biospecimen research participation

Abstract Background: Participation of racially diverse populations in research is necessary to advance cancer care. However, representation of Black individuals in biospecimen cancer research remains low and requires being asked to engage in research. We sought to understand the experiences, beliefs, and knowledge about biospecimen research among Black patients with lung cancer. Methods: Semi-structured interviews with a purposive sample of 15 Black patients diagnosed with lung cancer were conducted between January and August 2022 at a large academic center in North Carolina. Interviews were digitally recorded and transcribed and analyzed using thematic analysis. Results: Themes related to who should initiate discussions about biospecimen donation, what should be considered before donation, and communication strategies to increase participation of Black patients with cancer in biospecimen research emerged from the interviews. Most participants indicated that discussions about biospecimen donation should be initiated by trusted and knowledgeable members of the medical team and most expressed trusting their providers. Some also expressed the importance of including family members in discussions about medical and research decisions. Some participants felt it was important to consider if donating specimens would cause pain or would require additional procedures. Recommended communication strategies to facilitate participation included use of simple and easily understood language in addition to messaging related to how biospecimen donation would benefit others. Participants also felt cultural humility, respect, and empathy during research recruitment would help enhance enrollment of Black participants in biospecimen research. Of note, all participants reported never being asked to participate in biospecimen research and felt that underrepresentation of Black participants may be due to not being asked. Conclusion: Black participants in this study have not been asked to participate in biospecimen research but are willing to be engaged in conversations about research from their medical team. Simply being asked, trusting their medical provider, cultural humility, and framing the message on how the research will benefit others are some of the recommended strategies to enhance research participation among Black patients. Future research should incorporate these strategies into an intervention to assess the impact on recruiting Black individuals in biomedical research. Sponsored by the Lung Cancer Research Foundation Research Grant on Disparities in Lung Cancer Citation Format: Jeenn A. Barreiro-Rosa, Oluwatumilara Akeke, Annabella Opoku, Alison Hilton, Jessica Carda-Auten, Randall Teal, Aaron Carpenter, Hayley N. Morris, Lauren Matthews, Ashley Rankin Collins, Marjory Charlot. “Simply ask and explain”: perspectives from Black patients with lung cancer on strategies to address racial disparities in biospecimen research participation. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5534.

Abstract P2-12-01: A comprehensive assessment of researcher needs to increase biospecimen donations for breast cancer research: A Patients and Researchers Together (PART) Program

Abstract A comprehensive assessment of researcher needs to increase biospecimen donations for breast cancer research: A Patients and Researchers Together (PART) Program Introduction: Tissue-based breast cancer research can help translate scientific discoveries to improve treatments or reduce cancer risk. Tissue donation programs require a partnership between patients being asked to donate tissue and researchers using tissue for translational investigation. Lineberger Comprehensive Cancer Center (LCCC) has established a program called Patients and Researchers Together (PART) to increase the number of patients that donate tissue for research. PART believes patients will be more willing to donate tissue if they are informed about the research process and its impact and are valued as partners of LCCC. The PART program is evaluating the tissue donation process to positively impact efficiencies. Methods: PART leaders conducted interviews to assess current and future needs of LCCC cancer care providers involved in tissue-based research. A total of 13 breast cancer care providers at LCCC with different lengths of research experience were interviewed. These included 4 surgeons, 4 clinical study coordinators, 2 pathologists, 2 medical oncologists and 1 member of the Tissue Procurement Facility (TPF) staff. Interviewees identified key themes, provided insight into barriers and facilitators, and recommended resources to enhance the tissue-based research process. Results: Interviewees noted the high need for fresh tissue, which requires real-time coordination between clinicians, clinical study coordinators, surgeons, pathologists and researchers. Interviewees identified numerous barriers to the tissue donation process that hinder patient recruitment. These included: lack of knowledge about tissue-based research, time commitment required by an additional procedure, loss of privacy, lack of trust and knowledge about how the tissue will be used and access to cancer care (transportation). Interviewees also identified facilitators for recruiting patients to donate tissue for research, including: tailored communication between the patient and their cancer care team, a high interest in medical research, plain language and understandable educational materials and input of a trusted care team member at the appropriate time. Interviewees identified the need for additional tissue collection support and provided recommendations to improve the tissue donation process. Recommendations included: 1) increase the quantity of tissue available for research, 2) increase the racial and treatment history diversity of patients involved in tissue donation research, 3) increase diversity in the biological types of tissue donations (i.e., blood, stool, tumor), and 4) ensure that the available tissue is optimal for use in research. In addition, interviewees identified resources to enhance the tissue-based research process. One suggested resource is a team of coordinators tasked with managing the day-to-day operations of the tissue collection process and serving as a point of contact throughout. Ideally, the designated team would facilitate communication throughout the tissue collection process from the identification of a patient to the tissue’s use in research. Other recommendations included plain language patient educational materials, internal website improvements to enhance communication between researchers, and a written standard operating procedure guide shared with clinical and research team members. Finally, interviewees noted the importance of communication between tissue collection process stakeholders, highlighting the disparity in knowledge regarding best practices between new and more experienced researchers. Findings can inform the development of educational materials and other strategies to increase patient participation in tissue-based breast cancer research. Citation Format: Hayley Morris, Missy Van Lokeren, Patty Spears, Jennifer A. Potter, Vernal Branch, Patient And Researchers Together Team, Charles M. Perou, Lisa Carey. A comprehensive assessment of researcher needs to increase biospecimen donations for breast cancer research: A Patients and Researchers Together (PART) Program [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-12-01.

Educational video while "waiting-to-be-seen" in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial.

Consenting donors for remnant clinical biospecimen donation is critical for scaling research biorepositories. Opt-in, low-cost, self-consenting for donations that solely relied on clinical staff and printed materials was recently shown to yield ∼30% consent rate. We hypothesized that adding an educational video to this process would improve consent rates. Randomized patients (by clinic day) in a Cardiology clinic received either printed materials (control) or the same materials plus an educational video on donations (intervention) while waiting to be seen. Engaged patients were surveyed at the clinic checkout for an "opt-in" or "opt-out" response. The decision was documented digitally in the electronic medical record. The primary outcome of this study was the consent rate. Thirty-five clinic days were randomized to intervention (18) or control (17). Three hundred and fifty-five patients were engaged, 217 in the intervention and 158 in the control. No significant demographic differences were noted between treatment groups. Following an intention-to-treat analysis, the rate of opt-in for remnant biospecimen donation was 53% for the intervention and 41% for the control group (p-value = 0.03). This represents a 62% increase in the odds of consenting (OR = 1.62, 95% CI = 1.05-2.5). This is the first randomized trial showing that an educational video is superior to printed materials alone when patients are self-consenting for remnant biospecimen donation. This result adds to the evidence that efficient and effective consenting processes can be integrated into clinical workflows to advance universal consenting in medical research.

Assessment of Biobanking Knowledge and Attitudes towards Biospecimen Donation among Healthcare Providers in Saudi Arabia.

Background: Biobanking is a critical cornerstone of the global shift towards precision medicine (PM). This transformation requires smooth and informed interaction between a range of stakeholders involved in the healthcare system. In Saudi Arabia, there is still insufficient awareness of the importance of biobanking and its potential benefits for patients, the healthcare system, and society as a whole. The purpose of this study was to determine the biobanking knowledge of Saudi healthcare providers and the potential factors that might influence their self-reported attitudes toward biospecimen donation and biobanking. Methods: A cross-sectional study was conducted targeting 636 healthcare providers in Makkah province using a structured, self-administered questionnaire. Results: The study had a response rate of 61%. The mean knowledge level about biobanks was 3.5 (±1.8) out of 7. About one-third of the participants were aware of the Human Genome Project (HGP) (35%) or the term “biobank” (34%). The mean rating of their attitude was 37.3 (±4.3) out of 55. Most participants (74%) had a positive attitude toward medical research. Job position, general health, previous blood tests, knowledge of biobanking, and attitudes toward biomedical research were significantly related and predictors of willingness to donate biospecimens (p < 0.05). However, concerns about biospecimen misuse and confidentiality were the main reasons for not donating biospecimens. Conclusions: This study has shown that healthcare providers mostly lack basic knowledge about HGP and biobanks and their roles and activities, and therefore are generally disinclined to actively participate in biospecimens’ collection and management. It is recommended that medical trainees receive more education and awareness about biobanks and the latest personalized healthcare approaches to improve translational research outcomes and achieve precision medicine.

Pediatric biorepository participation during the COVID-19 pandemic: predictors of enrollment and biospecimen donation

BackgroundPatient-level predictors of enrollment in pediatric biorepositories are poorly described. Especially in pandemic settings, understanding who is likely to enroll in a biorepository is critical to interpreting analyses conducted on biospecimens. We describe predictors of pediatric COVID-19 biorepository enrollment and biospecimen donation to identify gaps in COVID-19 research on pediatric biospecimens.MethodsWe compared data from enrollees and non-enrollees aged 0–25 years with suspected or confirmed COVID-19 infection who were approached for enrollment in the Massachusetts General Hospital pediatric COVID-19 biorepository between April 12, 2020, and May 28, 2020, from community or academic outpatient or inpatient settings. Demographic and clinical data at presentation to care were from automatic and manual chart extractions. Predictors of enrollment and biospecimen donation were assessed with Poisson regression models.ResultsAmong 457 individuals approached, 214 (47%) enrolled in the biorepository. A COVID-19 epidemiologic risk factor was recorded for 53%, and 15% lived in a US Centers for Disease Control and Prevention-defined COVID-19 hotspot. Individuals living in a COVID-19 hotspot (relative risk (RR) 2.4 [95% confidence interval (CI): 1.8–3.2]), with symptoms at presentation (RR 1.8 [95% CI: 1.2–2.7]), or admitted to hospital (RR 1.8 [95% CI: 1.2–2.8]) were more likely to enroll. Seventy-nine percent of enrollees donated any biospecimen, including 97 nasopharyngeal swabs, 119 oropharyngeal swabs, and 105 blood, 16 urine, and 16 stool specimens, respectively. Age, sex, race, ethnicity, and neighborhood-level socioeconomic status based on zip code did not predict enrollment or biospecimen donation.ConclusionsWhile fewer than half of individuals approached consented to participate in the pediatric biorepository, enrollment appeared to be representative of children affected by the pandemic. Living in a COVID-19 hotspot, symptoms at presentation to care and hospital admission predicted biorepository enrollment. Once enrolled, most individuals donated a biospecimen.

Comparison of factors influencing the willingness to donate biospecimens among guardians of children with cancer and adult cancer patients.

BackgroundThis study examined and compared the attitudes and willingness of guardians of children with cancer and adult cancer patients toward donating biospecimens and clinical data for cancer research.MethodsWe conducted a cross‐sectional study among guardians of children with cancer (Guardian group) from Shanghai Children's Medical Center and adult cancer patients (Adult group) from Shanghai Ninth People's Hospital between February 1, 2019, and January 31, 2020. Participants’ demographic data, willingness, and motivations for biospecimen donation were collected and analyzed.ResultsOf 670 participants, 90.8% (318/350) in the Guardian group and 88.1% (282/320) in the Adult group completed the questionnaire. Most participants were willing to donate residual tissue samples (92.8% in the Guardian group vs. 79.4% in the Adult group, p ψ = 0.032) and clinical data (94.0% vs. 72.3%, p ψ < 0.001) for medical research. Logistic regression analysis indicated that only child status (odds ratio [OR] = 0.140, p = 0.02), history of blood donation (OR = 4.467, p = 0.019) in the Guardian group, education (OR = 0.387, p = 0.037), and history of blood donation (OR = 2.556, p = 0.016) in the Adult group were significantly associated with participants’ willingness to donate biospecimens. The primary motivation for donation was helping other patients with cancer (65.4% vs. 24.5%, p ψ < 0.001). The major barriers to donation were the potential to cause physical discomfort (61.0% vs. 64.9%, p ψ = 0.032).ConclusionsGuardians of children with cancer were more willing to donate biospecimens than adult cancer patients in China. It is essential to promote awareness of biospecimens donation, especially in adult cancer patients.

Perceptions of patients and medical oncologists toward biospecimen donation in the setting of abnormal breast imaging findings.

We sought to understand the attitudes of individuals with abnormal breast imaging findings prompting a diagnostic breast biopsy toward donation of blood, excised tissue, or percutaneous biospecimens for research, and to understand medical oncologists' attitudes toward research biospecimen collection in this population. We included individuals who presented to a single academic medical center for a clinically indicated, image-guided, percutaneous breast biopsy. We administered a survey prior to knowledge of biopsy results to assess willingness to consider, entirely for research purposes, donating blood or excess excised breast tissue, or having additional biospecimens (AB) obtained during a clinically indicated percutaneous biopsy. We also surveyed breast medical oncologists from National Cancer Institute-designated cancer centers to assess attitudes toward approaching patients for biospecimen research. Overall, 53/63 patients responded to the survey; 70% would consider donating blood, 85% would consider donating excess excised breast tissue, and 32% would consider having AB obtained during a clinically indicated biopsy. Main motivating factors for considering AB included contributing to scientific knowledge and return of study or biopsy results, whereas anxiety and the potential discomfort were the main dissuading factors. Among 191 medical oncologists, most were very comfortable (59.2%), or somewhat comfortable (32.5%) asking patients to have AB obtained during a clinically indicated breast biopsy. Medical oncologists reported hesitancy to refer a patient for AB due to potential pain/discomfort, and other procedure risks. Only one-third of individuals with breast imaging findings would consider consenting to AB during a diagnostic biopsy, whereas most were open to donating blood or excess excised breast tissue. Most medical oncologists would be comfortable asking patients to have AB obtained during the biopsy. Understanding patients' and oncologists' baseline attitudes may inform the design and approach to breast biospecimen-based research.

Abstract PO-085: A mixed-methods study of minority recruitment for cancer genomics research at a large urban safety net hospital

Abstract Background: Racial and ethnic minorities are underrepresented in cancer genomics research, and advancements in personalized medicine without inclusion of minority groups is likely to further exacerbate disparities in care and treatment outcomes. Prior research has demonstrated successful recruitment of minority populations for biospecimen donation through community-based approaches, physician engagement, culturally appropriate education, and on-site services. However, there is a significant gap in the literature regarding practical, low-cost interventions to maximize enrollment in biospecimen research studies at hospitals serving a diverse patient population. Objective: This study surveys eligible participants for cancer biospecimen research and aims to intervene on barriers to enrollment. Methods: Between January 2021 and June 2021, participants eligible for four different genomics studies were surveyed regarding reasons for consenting to biospecimen donation as well as barriers to participating among those who declined. The survey consists of six multi-part questions for a total of thirteen questions and requires an average of five minutes to complete. Results: Preliminary results include survey responses from 30 participants. Fourteen participants self-identified as Black or African American, twelve as White, two as Asian, and two as other. One participant self-identified as Hispanic. The majority of participants (73%) consented to biobank specimen collection including 50% of Black participants, 92% of White participants, and 100% of Asian and other participants. Of the eight participants who did not consent to donation, seven were Black. Among nine participants who reported that the study was recommended by their provider, all but one consented to donation. The majority of participants who consented to biospecimen collection reported contributing important information to medical science (73%) and potentially helping others with similar conditions in the future (68%) as reasons for donation. One participant who declined biospecimen donation reported that he would have felt less anxious if clinical staff had been present to explain the study. Two participants recommended including family members and other caregivers in the consent process, especially for older adults. One participant indicated difficulty reading through the consent form while another reported desire for more information “on the type of research” that would be conducted on the biospecimens. Conclusion: Our findings suggest that a majority of patients will consent to biospecimen collection, however Black patients are more likely to decline, and provider engagement is helpful. We found that our consent process can be improved with greater physician engagement, inclusion of family members and caregivers, and concise, patient-oriented presentation of information. Future work will involve implementation of interventions based on these findings. Citation Format: Tina Zhang, Nina Modanlo, David Li, Kiana Mahdaviani, Naomi Ko. A mixed-methods study of minority recruitment for cancer genomics research at a large urban safety net hospital [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-085.

Perspectives on Genetic Research: Results From a Survey of Navajo Community Members.

The Navajo Nation placed a moratorium on genetic research studies in 2002, in part due to concerns about historical distrust, exploitation, limited expertise and resources, and the lack of a genetics policy. Navajo tribal leaders, scientists, and policy experts are exploring the possibility of lifting the moratorium, developing a genetic research policy, and discussing its potential health implications. This study aimed to identify the key concerns, needs, and desires of Navajo people regarding genetic research. We conducted a survey of Navajo individuals to assess knowledge of the moratorium and research, gauge interest in genetic research, and quantify appropriate genetic research topics to understand broad views and concerns. We performed descriptive statistics and tested associations between relevant categorical variables using Chi-square tests. We hypothesized that individuals with more knowledge about the moratorium and health research increased the likelihood of supporting and participating in genetic research. A total of 690 surveys from Navajo respondents were analyzed. Of these, 63% of respondents reported being unaware of the Navajo Nation’s moratorium on genetic research. There were positive associations between those who knew about the moratorium and willingness to donate biospecimens for research under certain conditions, such as community involvement, review and approval by community leaders, research on diseases affecting the community, and support for lifting the moratorium (p-values < 0.001). We found no significant differences between age, gender, religious/spiritual beliefs, or agency affiliation with knowledge levels of genetics and related topics, participation in relation to beliefs, and donation of biospecimens. Interestingly, respondents who resided off the Navajo Nation were positively associated with having knowledge of the moratorium, having heard of discussions of genetics on the Navajo Nation, and the lawsuit filed by the Havasupai Tribe. Most respondents agreed that it was very important to develop a policy that incorporates cultural knowledge (56%), is beneficial (56%), and has data sharing protections (59%) before allowing genetic research on the Navajo Nation. Overall, a large proportion of respondents (46%) were unsure about lifting the moratorium and instead wanted more genetics education to assess its potential implications. The study results can inform the direction of future guidelines and policies.

Willingness of a Multiethnic Immigrant Population to Donate Biospecimens for Research Purposes.

This cross-sectional study explores the willingness to donate biospecimens for research purposes among six refugee communities in North Texas (spanning Myanmar, Central Africa, Somalia, Nepal, Arabic speaking countries, and others). Participants were asked four questions about biospecimen donation: (1) previously asked to donate, (2) ever agreed to donate, (3) willingness to donate for future research, and (4) what samples they would be willing to donate. Most participants (77%) were willing to donate biosamples for medical research; 58% were willing to donate samples. Fewer refugees from Somalia were willing to donate compared to immigrants from Myanmar, Central Africa, and Nepal (p < 0.01). Participants in the older age group (40 + years) were 3.2 times more likely to be willing for donation of biospecimens than the younger ones (OR 3.22, 95% CI 1.22, 8.55). Findings suggest refugees’ willingness to participate in biospecimen donation which support intentional inclusion of multicultural populations into medical research.

Development and Validation of a Biobank Questionnaire Intended for the Public in the Arab Region.

Background: Assessing the public perspectives regarding donation of biospecimens to biobanks would be helpful with the establishment of biobanks in the Arab region.Objective: To develop a biobanking questionnaire in Arabic and assess its psychometric properties.Design: Multicenter cross-sectional study.Methods: We used a two-step process for questionnaire development. First, we decided on the important constructs for a questionnaire followed by development of an item pool through review of the scientific literature and published questionnaires. The questionnaire was refined through cognitive interviews and translation. An expert panel assessed content validity. The final questionnaire included five domains: perceptions; aspects important to participation in biobank research; preferences for type of biobank; attitudes toward biobanking; and willingness to participate in biobank research. Second, we distributed the questionnaire to 250 members of the public from Egypt, Jordan, Sudan, and Morocco to assess the questionnaire's psychometric properties, including reliability (internal consistency and Cronbach's alpha) and construct validity (convergent and divergent validity and exploratory factor analysis [EFA]).Results: Internal consistency yielded a range of Cronbach's alpha for the five domains from 0.62 to 0.80. EFA showed a 12-factorial solution. Kaiser-Meyer-Olkin measure of sampling adequacy was 0.907 and Bartlett's test of sphericity was significant (p < 0.005). Attitudes were positively correlated with willingness to donate (r = 0.30; p < 0.001).Conclusions: The final biobank Arabic language questionnaire showed excellent reliability and acceptable validity parameters. The newly developed Arabic questionnaire is the first psychometrically tested tool that can be used in the Arab region to assess the public perspectives on participation in biobanking research.