Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Consent rate for germline testing (Initial Pilot Cohort and Part 2)
研究概览
简要总结
This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.
详细描述
PRIMARY OBJECTIVES:
I. To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach (Initial Pilot Cohorts).
II. To assess barriers to the intervention (Part 1). III. To evaluate consent rate of germline testing among participants receiving the intervention (Part 2).
SECONDARY OBJECTIVES:
I. To assess decisional conflict among African American men receiving tailored education strategies and culturally relevant cancer resources on genetic testing delivered by a community-based health coach (Initial Pilot Cohorts).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •CLOSED TO ENROLLMENT: INITIAL PILOT COHORT:
- •Participants:
- •Age >=18 years old.
- •Able to speak and read in English.
- •Have no known cancer risk genetic mutation.
- •Self-identify as Black or African American.
- •Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines.
- •ENROLLING: PART 1:
- •Participants:
- •Age >=18 years old.
- •Able to speak and read in English.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Able to verbally consent.
- •Self-identifies as Black or African-American.
- •Self-reports a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer.
- •Note: Participants may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback.
- •Self-identifies as a medical oncologist or genetics provider.
- •Able to speak and read in English.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Able to verbally consent.
- •ENROLLING: PART 2:
- •Participants:
- •Age >=18 years old.
- •Able to speak and read in English.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Able to provide written informed consent.
- •Have no known cancer risk genetic mutation.
- •Self-identify as Black or African American.
- •Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines.
- •For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed.
排除标准
- •CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.
- •Prior germline genetic test.
- •Age <18 years old.
- •Unable to read or answer forms.
- •ENROLLING: PART 1:
- •1. Contraindication to any study-related procedure or assessment.
- •ENROLLING: PART 2:
- •Self-reports prior germline genetic test.
- •Contraindication to any study-related procedure or assessment.
结局指标
主要结局
Consent rate for germline testing (Initial Pilot Cohort and Part 2)
时间窗: At baseline (1 day)
The consent rate for each cohort will be defined as proportion of patients enrolled in the study who agree to undergo germline genetic testing with Color genomics. The point estimate and 90% confidence interval will be provided.
Frequency of reported barriers to interventions (Part 1)
时间窗: Up to 30 days
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
次要结局
- Decisional conflict scale score (Initial Pilot Cohort and Part 2)(Up to 120 days)
- Frequency of reported facilitators to interventions (Part 1 and 2)(Up to 120 days)
- Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)(Up to 120 days)
- Frequency of reported barriers to interventions (Part 2)(Up to 120 days)
- Proportion of individuals classified as "supporters" (Part 2)(Up to 120 days)
- Proportion of participants who consent to study (Part 2)(Up to 120 days)
- Number of recorded inputs into ProGene (Part 1)(Up to 30 days)
- Proportion of patient participants who complete germline testing (Part 2)(Up to 120 days)
- Mean score of genetic testing attitudes survey (Part 2)(Up to 120 days)
- Frequency of reasons for declining testing (Part 2)(Up to 120 days)
- Mean score of adapted KnowGene germline testing knowledge survey (Part 2)(Up to 120 days)