Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Counseling Tool

    Other intervention

    Non-therapeutic educational intervention

  • Questionnaires

    Other intervention

    Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Stage 1: Tool DevelopmentExperimental treatment 2 interventions
Group B: Stage 1: Tool Implementation (Pilot Study)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Frequency of participant responses (Stage 1)

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.

Time frame
1 day
2

Proportion of enrolled participants (Stage 2)

The proportion of participants who enrolled in the study after being approached by their healthcare team will be reported.

Time frame
1 day
3

Proportion of enrolled participants who review all educational materials (Stage 2)

The proportion of all enrolled participants who utilized and reviewed all of the educational materials in the tool will be reported.

Time frame
Up to 60 days
4

Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)

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.

Time frame
Up to 60 days

Secondary outcomes

1

Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)

Scores on the AIM 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. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported.

Time frame
Up to 60 days
2

Mean score of investigator-developed, measure of acceptability items (Stage 2)

Scores on the 5-item investigator-developed, measure of acceptability 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. However, responses will not be averaged to across items; each item will be analyzed independently.

Time frame
Up to 60 days
3

Mean score of cancer genomic testing knowledge (Stage 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.

Time frame
Up to 60 days
4

Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2)

Knowledge of tumor genetic testing adapted from a validated survey from Blanchette, et al. including select questions from a survey from Rogith, et al. and is designed to measure the level of cancer genomic testing knowledge. Responses of "Don't know" will be scored as incorrect. Each of the item scores will be reported as a proportion of the participants who answered each item correctly. Since all items are required, we anticipate missing responses will be rare. Any missing data will be managed case-by-case post-hoc.

Time frame
Up to 60 days

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

Prostate Cancer Foundation

Collaborator