This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.
PRIMARY OBJECTIVES: I. To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach (Initial Pilot Cohorts). II. To assess barriers to the intervention (Part 1). III. To evaluate consent rate of germline testing among participants receiving the intervention (Part 2). SECONDARY OBJECTIVES: I. To assess decisional conflict among African American men receiving tailored education strategies and culturally relevant cancer resources on genetic testing delivered by a community-based health coach (Initial Pilot Cohorts). II. To assess facilitators to the intervention (Part 1). III. To assess acceptability of the intervention (Parts 1 and 2). IV. To characterize patient and health coach use of ProGene (Part 1). V. To evaluate completion rate of germline testing among participants receiving the intervention (Part 2). VI. To evaluate change in participant knowledge about germline testing among patient participants (Part 2). VII. To evaluate change in participant attitudes toward germline testing among patient participants (Part 2). VIII. To evaluate change in decisional conflict about germline testing among patient participants (Part 2). IX. To evaluate reach of the intervention (Part 2). X. To evaluate barriers and facilitators to the intervention (Part 2). XI. To identify reasons for declining germline testing. TERTIARY OBJECTIVE: I. To assess the germline mutation rate among African American men with prostate cancer (Initial Pilot Cohorts) OUTLINE: The initial pilot phase of the study has concluded. Participants are assigned to Parts 1 or 2 of current study. CLOSED TO ENROLLMENT: INITIAL PILOT COHORT A: Participants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may also undergo genetic testing. CLOSED TO ENROLLMENT: INITIAL PILOT COHORT B: Participants engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing. PART 1: Participants engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing. PART 2: Participants in this secondary pilot engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
72
Participate in educational session with health coach
Undergo genetic testing
Complete surveys throughout course of study.
AI Platform to be used by health coach during sessions
Participant and provider interviews will be conducted by study staff.
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
RECRUITINGSan Francisco Veterans Administration Medical Center
San Francisco, California, United States
NOT_YET_RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGConsent rate for germline testing (Initial Pilot Cohort and Part 2)
The consent rate for each cohort will be defined as proportion of patients enrolled in the study who agree to undergo germline genetic testing with Color genomics. The point estimate and 90% confidence interval will be provided.
Time frame: At baseline (1 day)
Frequency of reported barriers to interventions (Part 1)
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
Time frame: Up to 30 days
Decisional conflict scale score (Initial Pilot Cohort and Part 2)
The decisional conflict scale will be scored using a validated instrument. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Summary statistics with median and interquartile range will be obtained.
Time frame: Up to 120 days
Frequency of reported facilitators to interventions (Part 1 and 2)
Participant- and provider-reported facilitators to engaging in the intervention for participants to make an informed decision about germline testing.
Time frame: Up to 120 days
Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)
Participant-reported acceptability of the intervention will be described using the TFA questionnaire. Scores on the TFA items will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. All negatively worded items will be reverse-scored for a total score of 24-120. Higher scores represent greater acceptability (more positive attitudes). The mean score and standard deviation will be reported.
Time frame: Up to 120 days
Number of recorded inputs into ProGene (Part 1)
The number of recorded data inputs into the ProGene platform will be reported descriptively to characterize patient-participant and health coach use of ProGene.
Time frame: Up to 30 days
Proportion of patient participants who complete germline testing (Part 2)
The completion rate is defined as the proportion of patient-participants who complete germline testing within 90 days of intervention will be reported.
Time frame: Up to 120 days
Mean score of adapted KnowGene germline testing knowledge survey (Part 2)
Knowledge of tumor genetic testing adapted from a validated survey from Blanchette, et al.+ select questions from a survey from Rogith, et al. will be utilized to measure the level of cancer genomic testing knowledge. "Don't know" will be scored as incorrect. The proportion of correct responses will be calculated to generate a total score between 0-100, with a higher score indicating greater knowledge. No items will be weighted. Since all items are required, we anticipate missing responses will be rare. Any missing data will be managed case-by-case post-hoc.
Time frame: Up to 120 days
Mean score of genetic testing attitudes survey (Part 2)
Attitude and expectations measure for tumor genetic testing is a 17-item measure adapted from a validated survey from Blanchette, et al. including one open-ended investigator-created item. Items on the attitude scoring scale range from "Yes" = 1 and "No" or "Unsure" = 0
Time frame: Up to 120 days
Proportion of individuals classified as "supporters" (Part 2)
Proportion of individuals classified as "supporters" of genetic testing
Time frame: Up to 120 days
Proportion of participants who consent to study (Part 2)
Proportion of participants who consent to study among those approached as potential participants will be reported
Time frame: Up to 120 days
Frequency of reported barriers to interventions (Part 2)
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
Time frame: Up to 120 days
Frequency of reasons for declining testing (Part 2)
Patient-participant reported reasons for declining germline testing will be reported descriptively.
Time frame: Up to 120 days
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