Clinical trial NCT06171139: Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
Official title: Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostate Cancer Metastatic
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2023-12-14
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.

Detailed description: PRIMARY OBJECTIVES:

Stage 1: To evaluate education quality of the intervention in Black or African American men with prostate cancer.

Stage 2: To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer

SECONDARY OBJECTIVES:

Stage 1:

1. To evaluate completeness of the intervention content.
2. To identify barriers and facilitators for using the intervention.

Stage 2:

1. To evaluate the acceptability of the intervention among Black or African American men with prostate cancer.
2. To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer.
3. To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer.
4. To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer.
5. To evaluate patient perspectives on the intervention.
6. To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool.

OUTLINE:

This is a two-stage study. In Stage 1, Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT, or who have decided to undergo TGT, or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days. The investigators will then refine the tool to be piloted in Stage 2.

Stage 2: A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool, and answer questionnaires about the tool.

Eligibility criteria: Inclusion Criteria:

Stage 1:

1. Age 18-years-old or older
2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race including Black or African American is included.
3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
4. Able to understand study procedures and to comply with them for the entire length of the study.
5. Able to understand a written information sheet and willing to verbally consent.
6. Fluent in English (reading, writing, and speaking)

Stage 2:

1. Age 18-years-old or older
2. Identifies as Black or African-American, by either chart documentation or participant self-report. Mixed-race including Black or African-American is included.
3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
4. Able to understand study procedures and to comply with them for the entire length of the study.
5. Fluent in English (reading, writing, and speaking).
6. Anticipated discussion of TGT within 0-90 days of enrollment, per treating oncology provider's discretion. TGT involves use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:

   1. Somatic DNA testing of already-collected tissue.
   2. Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
   3. Blood-based DNA testing to evaluate for circulating tumor DNA.
7. Able to understand a written informed consent document and willing to sign it.

Exclusion Criteria:

Contraindication to any study-related procedure or assessment in either stage.

Primary outcomes:
measure: Frequency of participant responses (Stage 1)
timeFrame: 1 day
measure: Proportion of enrolled participants (Stage 2)
timeFrame: 1 day
measure: Proportion of enrolled participants who review all educational materials (Stage 2)
timeFrame: Up to 60 days
measure: Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)
timeFrame: Up to 60 days
Secondary outcomes:
measure: Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)
timeFrame: Up to 60 days
measure: Mean score of investigator-developed, measure of acceptability items (Stage 2)
timeFrame: Up to 60 days
measure: Mean score of cancer genomic testing knowledge (Stage 2)
timeFrame: Up to 60 days
measure: Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2)
timeFrame: Up to 60 days
measure: Proportion of participants who answer "Yes" to each attitude item in the Attitude and expectations for tumor genetic testing survey (Stage 2)
timeFrame: Up to 60 days
measure: Proportion of participants who answer "Strongly Agree" or "Agree" to the expectation item in the Attitude and expectations for tumor genetic testing survey (Stage 2)
timeFrame: Up to 60 days
measure: Participant-reported perspectives of intervention in a semi-structured interview. (Stage 2)
timeFrame: Up to 60 days
measure: Proportion of participants who have received the tumor genetic pre-test counseling tool who undergo TGT by chart review (Stage 2)
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Daniel Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: