Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Frequency of participant responses (Stage 1)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •Contraindication to any study-related procedure or assessment in either stage.
研究组 & 干预措施
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.
干预措施: Counseling Tool (Other)
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.
干预措施: Questionnaires (Other)
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.
干预措施: Counseling Tool (Other)
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.
干预措施: Questionnaires (Other)
结局指标
主要结局
Frequency of participant responses (Stage 1)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)