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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-01027 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Lazarex Cancer Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing) | Active Comparator | 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. |
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| CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing) | Experimental | Participants engage in 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. Participant and provider interviews will be conducted at end of study. |
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| Part 1 (educational session, survey, genetic testing) | Experimental | Participants engage in educational session lasting 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session over 15-30 minutes. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Participants may undergo genetic testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Participate in educational session with health coach |
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| Measure | Description | Time Frame |
|---|---|---|
| Consent 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. | 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. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing | Will be determined by the sum of all alterations detected on Color genomics. Summary statistics will be obtained. | At baseline and exit/follow-up visit (up to 2 days) |
Inclusion Criteria:
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT:
Participants:
ENROLLING: PART 1:
Participants:
Note: Participants may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback.
Providers:
ENROLLING: PART 2:
Participants:
Exclusion Criteria:
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.
ENROLLING: PART 1:
1. Contraindication to any study-related procedure or assessment.
ENROLLING: PART 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCSF Genitourinary Medical Oncology Recruitment | Contact | 877-827-3222 | GUTrials@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Kwon, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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| Part 2 Pilot (educational session, survey, genetic testing) |
| Experimental |
Clinical participants engage in educational session lasting about 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Community and clinical participants may undergo genetic testing. |
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| Genetic Testing | Other | Undergo genetic testing |
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| Survey Administration | Other | Complete surveys throughout course of study. |
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| ProGene Artificial Intelligence (AI) Platform | Other | AI Platform to be used by health coach during sessions |
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| Interviews | Other | Participant and provider interviews will be conducted by study staff. |
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| 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. |
| 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. | 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. | 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. | 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. | 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 | Up to 120 days |
| Proportion of individuals classified as "supporters" (Part 2) | Proportion of individuals classified as "supporters" of genetic testing | 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 | 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. | Up to 120 days |
| Frequency of reasons for declining testing (Part 2) | Patient-participant reported reasons for declining germline testing will be reported descriptively. | Up to 120 days |
| San Francisco Veterans Administration Medical Center | Not yet recruiting | San Francisco | California | 94121 | United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D005820 | Genetic Testing |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D003954 | Diagnostic Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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