임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07436078은(는) 여성 유방암, 전립선암, 대장직장 암종에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Culturally Adapting an Intervention to Increase Genetic Testing in African American Cancer Survivors 85
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07436078은(는) 여성 유방암, 전립선암, 대장직장 암종에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2026년 4월 1일에 시작되어 85명의 참여자를 모집하고 있습니다. Barbara Ann Karmanos Cancer Institute이(가) 진행하며, 2029년 7월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 27일에 갱신되었습니다.
간단한 개요
The goal of this clinical trial is to culturally adapt an educational genetic counseling intervention to increase the uptake in genetic counseling and testing among African Americans at risk for heredity cancers. With the help of community stakeholders and clinical genetic professionals the investigators will:
- adapt and refine a culturally relevant online educational genetic counseling program for at-risk African ...
공식 제목
A Community-Engaged Approach to Culturally Adapting an Intervention to Increase Uptake of Genetic Testing Among African American Cancer Survivors
질환명
여성 유방암전립선암대장직장 암종기타 연구 식별자
NCT 번호
실제 연구 시작일
2026-04
최신 업데이트 게시
2026-02-27
예상 연구 완료일
2029-07
계획된 등록 인원
85
연구종류
중재연구
단계/상
해당 없음
상태
모집중
주요 목적
건강 서비스 연구
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Online Culturally adapted Genetic Counseling Information Culturally developed online Genetic counseling information will be provided. Questionnaires will be administered pre and post genetic counseling intervention as well as 3 months post intervention | Culturally adapted Online Genetic Counseling and Testing Information Testing the effects of the educational intervention designed to increase the uptake of genetic counseling testing among at-risk African American survivors |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Uptake of genetic counseling and genetic testing | One item question will ask whether participants have participated in genetic counseling and genetic testing (Yes or No) | 3 month follow Up |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Intention to undergo genetic counseling and testing | This 2-item measure assesses participant's intentions to undergo genetic counseling and testing (Yes or No) | 1 day Pre Intervention to 1 day Post Intervention |
Sharing Your Results | This author-developed 3-item measure assesses the extent to which participants shared information from (1) the video, (2) their counseling appointment, or (3) their testing results with their family. Each item is scored individually as binary (Yes or No) with yes=sharing and no=did not share. | 3 month follow up |
Major Experiences of Discrimination | This 18-item measure assesses whether participants have had 9 major experiences of discrimination (e.g., getting employment, housing, medical care) happen to them (responses: 1=once, 2=2-3 times, 3=4+ times, or 0=never happened). Responses (range 0-27) are summed into an Experiences score with higher score = greater experiences of racism. If participants who respond (1, 2, 3), for any item, they are asked to report the last time this happened (1=past week, 2=past month, 3=past year, 4=more than a year ago). These responses are averaged to create a Frequency score (range 1-4), which is multiplied by the Experiences scores to obtain a Severity score (range 9-108) with higher scores = higher severity of major experiences of discrimination experiences. The Experiences and Severity scores will be assessed as moderators of change in the primary outcomes. | 1 day prior to intervention |
Everyday Experiences of Discrimination | This 5-item scale measure assesses experience of discrimination that participants might experience on daily basis (e.g., poor service in a restaurant, getting harassed). Responses are (1=almost everyday, 2=at least once a week, 3=a few times a month, 4=a few times a year, 5=less than once a year, 6=never). Responses (range 5-30) are summed, and all items are when reverse scored, higher scores = greater experiences of everyday discrimination. This measure will be assessed as a moderator of change in the primary outcomes.
For item with a score of 1-4, participants are asked to name the main reason for the discrimination (examples: ancestry or national origin, gender, race, age, religion, weight). This item is described qualitatively. | 1 day prior to intervention |
Interpersonal Processes of Care Survey | This 13-item scale is designed to measure race-specific perceptions of communication between patient and healthcare providers (e.g., compassion, discrimination, and disrespectful office space). Responses are (1=never, 2=rarely, 3=sometimes, 4=usually, 5=always). The first 9 items (mean range 1-5) with higher scores=higher levels of compassion and (reverse scored) lower discrimination. The next 4 items (mean range 1-5) with higher scores=higher disrespectful attitudes from office staff. The two subscales will be assessed as moderators of change in the primary outcomes | 1 day prior to intervention |
Group-Based Medical Mistrust Scale | This 12-item scale was developed to measure race-based medical mistrust: the suspicion of mainstream health care systems and professionals and the treatment provided to individuals because they are African American. The items are scored with responses (1=strongly disagree, 2=disagree, 3=neither agree or disagree, 4=agree, 5=strongly agree). Higher scores (mean range 1-5)=higher levels of mistrust of providers. This measure will be assessed as a primary outcome of the intervention | 1 day prior to intervention |
Perceived Access to Health Care Services | This 13-item, 4-point Likert-style scale was designed to measure perceptions of ability to get care, considering barriers such as cost, availability, and cultural fit. The scale includes items on cost and access to services. The responses are (1=strongly disagree., 2=disagree, 3=agree, 4=strongly agree) with a mean range of 1-4. Higher score=greater participation in cancer screening and a higher family income level. | 1 day prior to intervention |
Perceived risk of carrying genetic mutation | This 1-item measure ("How likely do you think it is that you carry a genetic mutation that increases your risk for cancer?") assesses perceived risk of carrying a genetic mutation that increases risk for cancer. The item is scored (1=not at all to 5=extremely likely; range 1-5). Higher scores=higher perceived likelihood of carrying a genetic mutation. | 1 day Pre Intervention to 1 day Post Intervention |
Attitudes about genetic counseling and testing | This 8-item scale is designed to measure positive and negative attitudes about the genetic counseling and testing process using the following 8 adjectives: worthwhile, worrying, reassuring, uncomfortable, wise, healthy, unpleasant, and important. Responses are (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher summed scores (range is 8-40)=more positive attitudes. | 1 day Pre Intervention to 1 day Post Intervention |
Behavioral beliefs about genetic counseling | This 30-item scale measures genetic counseling-related beliefs and concerns across the following 6 subscales: "pros" of genetic counseling, "cons" of genetic counseling, competing concerns, cultural concerns, logistic concerns, and desire for more information. The responses are (1=strongly disagree, 2=moderately disagree, 3=neither agree nor disagree, 4=moderately agree, 5=strongly agree). Higher scores (range 15-75)=more positive beliefs. | 1 day Pre Intervention to 1 day Post Intervention |
Perceived norms | This 10-item measure assesses injunctive and descriptive norms (5 items each) about genetic counseling. Responses are scored on a 5-point Likert scale (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher scores (range 1=25)=stronger perceived norms for each of the subscales ((injunctive norms and descriptive norms, respectively). | 1 day Pre Intervention to 1 day Post Intervention |
Knowledge of Genetic Counseling | This 5-item scale is designed to evaluate an individual's basic knowledge of the genetic counseling process (e.g., How much have you read or heard about genetic counseling for: inherited disease? Cancer, in general?). Items are scored (1=very much to 7=not at all). (Reversed) Higher scores (mean range 1-7)=higher knowledge of genetic counseling. | 1 day Pre Intervention to 1 day Post Intervention |
Perceived self-Efficacy | This 10-item measure assesses participant's perceived self-efficacy for pursuing genetic counseling if they were interested. Responses are (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher scores (mean range=1-5)=higher self efficacy for pursuing genetic counseling. | 1 day Pre Intervention to 1 day Post Intervention |
Multidimensional Impact of Cancer Risk Assessment | This 25-item scale is designed to evaluate participant emotional responses after genetic testing, regardless of result, across 3 subscales (Distress, Uncertainty, and Positive Experiences-reverse scored). The responses are 0=never, 1=rarely, 3=sometimes, 5=often. Total summed score range=0-95. Higher scores=stronger emotional impact of testing results on the individual. The measure will be assessed as part of the intervention outcomes. | 3 month Follow Up |
Cancer Family Impact | This 18-item scale is designed to measure the flow of information and communication about cancer in families, thoughts about family norms about cancer prevention, and the effects of cancer on families across 5 subscales (Flow: flow of information about cancer in families; Negative: negative effects of cancer on the family; Positive: positive effects of cancer on the family; Communicate: how families communicate with each other about cancer; and Norm: reaction to family norms about cancer prevention). The responses are (0=strongly disagree, 1=disagree, 2= neither agree or disagree, 3=agree 4= strongly agree). Higher total (range 0-90) summed scores=greater communication about cancer within the family. The measure will be assessed as part of the intervention | 3 Month Follow Up |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
20 Years
참여 가능한 성별
전체
- Participants enrolled in Detroit Research on Cancer Survivors (Detroit ROCS)
- Diagnosis of Primary Breast, prostate, or colorectal cancer on or after 1/1/2013
- have received or currently receiving care at Karmanos Cancer Institute
- meet one or more of the National Comprehensive Cancer Network (NCCN) guidelines for cancer genetic testing as described below
Female breast
- personal diagnosis at age ≤50
- personal history of the triple-negative subtype
- at least 1 close (first- or second-degree) relative diagnosed with breast cancer at age <50
- at least 1 close relative diagnosed with ovarian cancer
- 2+ close relatives diagnosed with breast or prostate cancer
- age <50 AND another primary breast cancer at any age
- 2+ primary breast cancers at any age
OR Prostate
- personal history of high-risk or very high-risk prostate cancer
- personal history of regional or metastatic prostate cancer
- personal history of less than high-risk prostate cancer with a suggestive family history (i.e., father or brother or multiple relatives with prostate cancer diagnosed at age <60; at least 1 relative with breast, ovarian, or pancreatic cancer; or at least 1 relative with colorectal, ovarian, pancreatic, or kidney cancer)
OR Colorectal
- personal diagnosis at age ≤50
- at least 1 close relative diagnosed with HNPCC at age <50
- at least 2 close relatives diagnosed with an HNPCC cancer at any age
- colorectal and >=1 primary endometrial, ovarian, gastric, pancreatic, or prostate
- Previous genetic counseling and/or testing
Barbara Ann Karmanos Cancer Institute미국 국립암연구소연구 책임자
Felicity Harper, 책임연구자, Principal Investigator, Barbara Ann Karmanos Cancer Institute
연구 대표 연락처
연락처: Jasminder Phalore, MPH, 313-576-9735, [email protected]
1 1개국에 임상시험 장소
Michigan
Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
Jasminder Phalore, MPH, 연락처, 313-576-9735, [email protected]
Hayley Thompson, Ph.D, 공동연구자
Felicity WK Harper, Ph.D, 책임연구자
모집중