CRC 스크리닝에 대한 Protect Your Colon™의 영향을 평가하는 파일럿 시험
Protect Your Colon™이 대장암 검진 행동에 미치는 영향을 평가하는 파일럿 무작위 대조 시험
The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
California
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Individuals 45 to 75 years old
- No prior CRC screening or not up-to-date with CRC screening
- Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC)
- No prior colon polyps
- Additional inclusion criteria for participants recruited through Cint online survey panels: (i) appointment with a primary care provider up to 6 weeks from time of screening, and (ii) have Preferred Provider Organization (PPO) insurance.
Exclusion Criteria:
- Does not speak English
- Does not have internet access
- Any records flagged "break the glass" or "research opt out."
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Protect Your Colon™ (Intervention)
Patients randomized to Protect Your Colon™ will be directed to go through the website before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit. |
Protect Your Colon™ is an online decision aid focused on CRC screening. The site will first educate patients on the importance of CRC screening and offer information on the advantages and disadvantages of the available test options. Protect Your Colon™ will then present an interactive conjoint analysis-a quantitative survey technique that elucidates how individuals make complex decisions-to precisely determine individuals' latent preferences regarding CRC screening options. Afterwards, the app will generate a personalized report that rank orders the importance of each test attribute (e.g., accuracy, invasiveness, test frequency) in patients' decision making and identifies the screening modality that best matches their preferences. The report will also be shareable with physicians, enabling patients and providers to engage in shared decision making surrounding CRC screening in the clinic. |
|
간섭 없음: Usual Care (Control)
The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of completion of a CRC screening test
기간: 6 months post visit
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Uptake of CRC screening within 6 months of patients' initial visit |
6 months post visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Qualitative feedback on details of CRC screening test
기간: 1 day post visit
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Completion of questionnaire that looks at:
|
1 day post visit
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Christopher V Almario, MD, MSHPM, Cedars-Sinai Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
IPD 공유 기간
Data will become available after study completion and for up to 3 years after study completion.
IPD 공유 액세스 기준
The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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