Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Counseling Tool, Questionnaires.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Prostate Cancer Metastatic. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
Overview
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.
Interventions
- Other Counseling Tool
Non-therapeutic educational intervention - Other Questionnaires
Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.
Primary outcome measures
- Frequency of participant responses (Stage 1) [Time frame: 1 day]
- Proportion of enrolled participants (Stage 2) [Time frame: 1 day]
- Proportion of enrolled participants who review all educational materials (Stage 2) [Time frame: Up to 60 days]
- Mean score of Feasibility of Intervention Measure (FIM) (Stage 2) [Time frame: Up to 60 days]
Secondary outcome measures (8)
- Mean score of Acceptability of Intervention Measure (AIM) (Stage 2) [Time frame: Up to 60 days]
- Mean score of investigator-developed, measure of acceptability items (Stage 2) [Time frame: Up to 60 days]
- Mean score of cancer genomic testing knowledge (Stage 2) [Time frame: Up to 60 days]
- Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2) [Time frame: Up to 60 days]
- Proportion of participants who answer "Yes" to each attitude item in the Attitude and expectations for tumor genetic testing survey (Stage 2) [Time frame: Up to 60 days]
- 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) [Time frame: Up to 60 days]
- Participant-reported perspectives of intervention in a semi-structured interview. (Stage 2) [Time frame: Up to 60 days]
- Proportion of participants who have received the tumor genetic pre-test counseling tool who undergo TGT by chart review (Stage 2) [Time frame: Up to 90 days]
Eligibility criteria
Inclusion criteria
Stage 1:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written information sheet and willing to verbally consent.
- Fluent in English (reading, writing, and speaking)
Stage 2:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Fluent in English (reading, writing, and speaking).
- Anticipated discussion of TGT within 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:
- Somatic DNA testing of already-collected tissue.
- Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
- Blood-based DNA testing to evaluate for circulating tumor DNA.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of California — San Francisco
Identifiers
NCT: NCT06171139 · 23553 · NCI-2023-10339