Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Counseling Tool
- Conditions
- Prostate Cancer
- Sponsor
- University of California, San Francisco
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Frequency of participant responses (Stage 1)
- Status
- Recruiting
- Last Updated
- 16 days ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •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.
Exclusion Criteria
- •Contraindication to any study-related procedure or assessment in either stage.
Arms & Interventions
Stage 1: Tool Development
Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed.
Intervention: Counseling Tool
Stage 1: Tool Development
Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed.
Intervention: Questionnaires
Stage 1: Tool Implementation (Pilot Study)
Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview.
Intervention: Counseling Tool
Stage 1: Tool Implementation (Pilot Study)
Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview.
Intervention: Questionnaires
Outcomes
Primary Outcomes
Frequency of participant responses (Stage 1)
Time Frame: 1 day
Participant-reported perspectives of intervention in a semi-structured interview will be collected during Stage 1 and reviewed and will be explored using thematic analysis. A codebook will be created using the PEMAT (for the primary objective) described in the interview guide. This framework provides a systematic approach for identifying behavior change models evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behavior. This will produce evidence-based behavior change techniques most likely to be effective. Emergent codes and themes will be added throughout thematic analysis. Two coders will code each interview (one primary and one secondary coder). Discrepancies will be negotiated to consensus.
Proportion of enrolled participants (Stage 2)
Time Frame: 1 day
The proportion of participants who enrolled in the study after being approached by their healthcare team will be reported.
Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)
Time Frame: Up to 60 days
Scores on the FIM 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. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported.
Proportion of enrolled participants who review all educational materials (Stage 2)
Time Frame: Up to 60 days
The proportion of all enrolled participants who utilized and reviewed all of the educational materials in the tool will be reported.
Secondary Outcomes
- Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)(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)(Up to 60 days)
- Participant-reported perspectives of intervention in a semi-structured interview. (Stage 2)(Up to 60 days)
- Mean score of investigator-developed, measure of acceptability items (Stage 2)(Up to 60 days)
- Mean score of cancer genomic testing knowledge (Stage 2)(Up to 60 days)
- Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2)(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)(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)(Up to 90 days)