Healthy Subject, Prostate Carcinoma
Conditions
Brief summary
This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.
Interventions
BEHAVIORALCancer Educational Materials
Receive prostate cancer educational materials
OTHERQuestionnaire Administration
Ancillary studies
OTHEREducational Intervention
Attend peer-led education sessions
Sponsors
Thomas Jefferson University
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to read and speak English comfortably * With or without a personal or family history of PCA * Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate
Exclusion criteria
* Do not read or speak English comfortably * Men who participated in a focus group will be excluded from participating in the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in of decisional conflict | Baseline up to 2 months | Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test. |
| Awareness of risks and benefits of genetic testing | Up to 2 months post study | Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects. |
| Perceptions of genetic testing | Up to 2 months post study | Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. |
| Genetic testing | Up to 2 months post study | Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. |
Countries
United States
Outcome results
None listed