Abstract 2540: Belief in research, religious coping, and willingness to participate in clinical trials among African Americans with hematologic malignancies: a pilot study

2021 ◽  
Author(s):  
Marjorie Petty
Keyword(s):  
Clinical Trials ◽  
Pilot Study ◽  
African Americans ◽  
Religious Coping ◽  
Hematologic Malignancies ◽  
Willingness To Participate

scholarly journals Sickle Cell Disease Patients Demonstrate a High Willingness to Participate in Randomized Clinical Trials

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5808-5808
Author(s):  
Volha Mazziotto ◽  
Katrina Mikofalvy ◽  
Alexandra Houck ◽  
Lauren Beck ◽  
Prasad V. Bodas
Keyword(s):  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
Randomized Clinical Trials ◽  
Willingness To Participate ◽  
Participation Rates ◽  
Cell Disease ◽  
African American Population ◽  
The Us ◽  
Reported Data

Abstract Background: African Americans are underrepresented in randomized clinical trials (RCTs). Underrepresentation of this patient group may lead to an inadequate analysis of therapy risks and benefits, and study findings may not be generalizable to a diverse patient population. Moreover, low representation of African Americans in existing clinical trials may discourage future trials focused on this population, as such trials are perceived to be infeasible. Barriers to participation in clinical trials have been extensively studied. Frequently identified factors include: systemic barriers (availability of clinical trials, eligibility barriers, lack of resources), geography (location of the research institution and access to transportation), and individual-level barriers such as low education, poverty, and poor access to healthcare. Willingness to participate has been cited as a major barrier, related to distrust in the US healthcare systemand to cultural and religious beliefs. Yet a dearth of empirical evidence bolsters the assertion that willingness to participate in clinical trials among African Americans is accountable for underrepresentation. We performed a retrospective review of major RCTs focused on sickle cell disease (SCD) in order to measure willingness of African Americans to participate in clinical research. Methods: We systematically identified landmark peer-reviewed RCTs focused on SCD. We analyzed the results of these trials reported in the medical literature and calculated participation and completion rates for each trial. For each study, we identified the number of subjects screened for participation, the number who agreed to participate, and the number who declined. We calculated ratios for study acceptance and study completion. We identified the number of publications which clearly reported data from which acceptance to participate could be directly calculated, the number from which participation could be inferred, or from which reported data were insufficient. Results: We identified 13 RCTs published between 1986 and 2018, representing the major clinically impactful studies in children and adults with SCD. Six of the 13 studies reported sufficient data to infer or calculate participation rates. It is notable that more than half (54%; n=7) of the studies provided insufficient data to calculate study acceptance rates. Our analysis encompassing 2407 patients included in six studies indicates that 82% of subjects with SCD demonstrated willingness to participate in an RCT (range 32-94%), and 95% of clinical trial subjects completed study activities (range 92-98%). Discussion: A minority of publications reported participation data. One of the 13 studies published data on the race of participants, reporting 94% of participants were African American and 3% were Hispanic. However, since SCD predominantly affects African Americans (approximately 90% of those with SCD nationwide are African American and approximately 10% are Hispanic), it is reasonable to estimate that the subjects in our analysis represent a predominantly African American population. We acknowledge that subjects with SCD may not be representative of the US African American population in total. Nonetheless, our findings contradict the assertion that African Americans are less willing to participate in clinical trials, or that African Americans have disproportionately high drop-out rates. Only a minority of publications reported data required to calculate participation rates. Despite this limitation, available empiric evidence suggests that when participation in high-quality clinical trials is made available, African Americans demonstrate a willingness and capacity to enroll and complete study participation. The generalized assertion that African American patients' willingness to participate in research is a major factor in their underrepresentation in clinical trials is false. Researchers should design high-quality clinical trials that include this underrepresented group at the outset, and investigators should be encouraged to collect and report participation data more carefully so that this disparity can be measured and addressed. Disclosures No relevant conflicts of interest to declare.

scholarly journals A Pilot Study of a Culturally-Appropriate, Educational Intervention to Increase Participation in Cancer Clinical Trials Among African Americans and Latinos

2021 ◽  
Author(s):  
Jennifer Cunningham-Erves ◽  
Tilicia Mayo-Gamble ◽  
Pamela C Hull ◽  
Tao Lu ◽  
Claudia Barajas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
African Americans ◽  
Educational Program ◽  
Trial Participation ◽  
Willingness To Participate ◽  
Culturally Appropriate ◽  
Clinical Trial Participation ◽  
Medical Researchers ◽  
Town Halls

Abstract Aim: Culturally-appropriate, educational programs are recommended to improve cancer clinical trial participation among African Americans and Latinos. This study investigated the effect of a culturally-appropriate, educational program on knowledge, trust in medical researchers, and intent for clinical trial participation among African Americans and Latinos in Middle Tennessee.Method: Trained community health educators delivered a 30-minute presentation with video testimonials to 198 participants in 13 town halls. A pre-post survey design was used to evaluate the intervention among 102 participants who completed both pre- and post-surveys one to two weeks after the session. Results: Paired-sample t-test showed significant increases in unadjusted mean scores for knowledge (p < .001), trust in medical researchers (p < .001), and willingness to participate in clinical trials (p = .003) after the town halls in the overall sample. After adjusting for gender and education, all three outcomes remained significant for the overall sample (knowledge: p < .001; trust in medical researchers: p < .001; willingness: p = .001) and for African Americans (knowledge: p < .001; trust in medical researchers: p = .007; willingness: p = .005). However, willingness to participate was no longer significant for Latinos (knowledge: p < .001; trust in medical researchers: p = .034; willingness: p = .084).Conclusions: The culturally-appropriate, educational program showed promising results for short-term, clinical trial outcomes. Further studies should examine efficacy to improve research participation outcomes.

scholarly journals A pilot study of a culturally-appropriate, educational intervention to increase participation in cancer clinical trials among African Americans and Latinos

2021 ◽  
Author(s):  
Jennifer Cunningham-Erves ◽  
Tilicia L. Mayo-Gamble ◽  
Pamela C. Hull ◽  
Tao Lu ◽  
Claudia Barajas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pilot Study ◽  
African Americans ◽  
Educational Intervention ◽  
Cancer Clinical Trials ◽  
Culturally Appropriate

The Use of Religious Coping Strategies for African-Americans Following Residential Fires

2007 ◽  
Author(s):  
Rachel Moore ◽  
Michael Knepp ◽  
Christopher Immel ◽  
Russell Jones ◽  
Thomas Ollendick
Keyword(s):  
African Americans ◽  
Coping Strategies ◽  
Religious Coping ◽  
Residential Fires

Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jisook Ko ◽  
Yan Du ◽  
Rozmin Jiwani ◽  
Chengdong Li ◽  
Jing Wang
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Pilot Study ◽  
Glycemic Control ◽  
Asian Americans ◽  
Control Group ◽  
Management Approach ◽  
Self Monitoring ◽  
Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

scholarly journals Influence of chronotype on daily mood fluctuations: pilot study in patients with depression

BJPsych Open ◽  
2020 ◽  
Vol 6 (2) ◽  
Author(s):  
Konstantin F. Brückmann ◽  
Jürgen Hennig ◽  
Matthias J. Müller ◽  
Stanislava Fockenberg ◽  
Anne-Marthe Schmidt ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pilot Study ◽  
Negative Affect ◽  
Clinical Setting ◽  
Early Morning ◽  
Healthy Controls ◽  
Patient Subgroup ◽  
Depression Risk ◽  
Gender And Age ◽  
The Relationship

Summary Depression risk is associated with a late chronotype pattern often described as an ‘evening chronotype’. Fluctuations in mood over consecutive days have not yet been measured according to chronotype in in-patients with depression. A total of 30 in-patients with depression and 32 healthy controls matched for gender and age completed a chronotype questionnaire and twice-daily ratings on mood for 10 consecutive days (registered in the German Clinical Trials Register: DRKS00010215). The in-patients had Saturdays and Sundays as hospital-leave days. The relationship between chronotype and daily mood was mediated by the weekday–weekend schedule with higher levels of negative affect in the evening-chronotype patient subgroup at weekends. Results are discussed with respect to a probably advantageous standardised clinical setting with early morning routines, especially for patients with evening chronotypes.

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