Prostate Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERInterviews
Participant and provider interviews will be conducted by study staff.
OTHEREducational Intervention
Participate in educational session with health coach
OTHERGenetic Testing
Undergo genetic testing
OTHERSurvey Administration
Complete surveys throughout course of study.
OTHERProGene Artificial Intelligence (AI) Platform
AI Platform to be used by health coach during sessions
Sponsors
Lazarex Cancer Foundation
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT: Participants: 1. Age \>=18 years old. 2. Able to speak and read in English. 3. Have no known cancer risk genetic mutation. 4. Self-identify as Black or African American. 5. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines. ENROLLING: PART 1: Participants: 1. Age \>=18 years old. 2. Able to speak and read in English. 3. Able to understand study procedures and to comply with them for the entire length of the study. 4. Able to verbally consent. 5. Self-identifies as Black or African-American. 6. Self-reports a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer. Note: Participants may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback. Providers: 1. Self-identifies as a medical oncologist or genetics provider. 2. Able to speak and read in English. 3. Able to understand study procedures and to comply with them for the entire length of the study. 4. Able to verbally consent. ENROLLING: PART 2: Participants: 1. Age \>=18 years old. 2. Able to speak and read in English. 3. Able to understand study procedures and to comply with them for the entire length of the study. 4. Able to provide written informed consent. 5. Have no known cancer risk genetic mutation. 6. Self-identify as Black or African American. 7. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines. 8. For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed.
Exclusion criteria
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT. 1. Prior germline genetic test. 2. Age \<18 years old. 3. Unable to read or answer forms. ENROLLING: PART 1: 1\. Contraindication to any study-related procedure or assessment. ENROLLING: PART 2: 1. Self-reports prior germline genetic test. 2. Contraindication to any study-related procedure or assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of reported barriers to interventions (Part 1) | Up to 30 days | Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively. |
| Consent rate for germline testing (Initial Pilot Cohort and Part 2) | At baseline (1 day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of reported facilitators to interventions (Part 1 and 2) | Up to 120 days | Participant- and provider-reported facilitators to engaging in the intervention for participants to make an informed decision about germline testing. |
| Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2) | Up to 120 days | 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. |
| Number of recorded inputs into ProGene (Part 1) | Up to 30 days | The number of recorded data inputs into the ProGene platform will be reported descriptively to characterize patient-participant and health coach use of ProGene. |
| Proportion of patient participants who complete germline testing (Part 2) | Up to 120 days | The completion rate is defined as the proportion of patient-participants who complete germline testing within 90 days of intervention will be reported. |
| Mean score of adapted KnowGene germline testing knowledge survey (Part 2) | Up to 120 days | 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. |
| Proportion of individuals classified as supporters (Part 2) | Up to 120 days | Proportion of individuals classified as supporters of genetic testing |
| Proportion of participants who consent to study (Part 2) | Up to 120 days | Proportion of participants who consent to study among those approached as potential participants will be reported |
| Frequency of reported barriers to interventions (Part 2) | Up to 120 days | Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively. |
| Frequency of reasons for declining testing (Part 2) | Up to 120 days | Patient-participant reported reasons for declining germline testing will be reported descriptively. |
| Mean score of genetic testing attitudes survey (Part 2) | Up to 120 days | 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 |
| Decisional conflict scale score (Initial Pilot Cohort and Part 2) | Up to 120 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing | At baseline and exit/follow-up visit (up to 2 days) | Will be determined by the sum of all alterations detected on Color genomics. Summary statistics will be obtained. |
Countries
United States
Contacts
Primary ContactUCSF Genitourinary Medical Oncology Recruitment
Outcome results
None listed