- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01626014
Interactive Educational Website for Women With Ovarian Cancer & Caregivers
Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers
연구 개요
상태
상세 설명
In this study, we will pilot-test a technology-based approach for women with Stage III/IV or recurrent ovarian cancer, their caregiver, and their providers to assist in and study the decision-making process that surrounds end-of-life decisions, specifically, opting for palliative care and/or entry into hospice care. We will randomize the women and their caregivers into either our intervention or control websites. All subjects will complete a battery of demographic, psychosocial, health status and outcomes, health information, and decision making measures at baseline and 60-day post-baseline.
Once the participant has completed the baseline survey, he/she will be automatically brought to their assigned website. Both the patient and their caregiver will be assigned the same group (intervention or control). All participants will have open access to their respective study websites for a minimum of 60 days. During enrollment, participants will agree to access their respective websites at least 2-3 times per week. Both patients and caregivers assigned to the control arm will view a website containing documents generally provided as part of the usual care. They will be requested to log in with the same frequency as the intervention group.
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center, University of Minnesota
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women with Stage III, IV or recurrent ovarian, primary peritoneal or fallopian tube cancer or a nominated caregiver or such women
- 18 years old or older
- At least a 5th grade education
- Able to read and write in English
- Access to computer and internet
- Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- No known major psychiatric or neurological diagnosis (schizophrenia or active chemical dependency)
Exclusion Criteria:
- Borderline ovarian cancer
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Group
Using the Prototype System website: An interactive educational system for patients and their caregivers includes features allowing users to create their own profile, share a journal with others, and post to respective discussion forums.
In addition, core intervention components include distress monitoring, educational items, details about the healthcare team and an areas to keep track of questions for providers.
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An interactive system for patients and their caregivers includes features allowing users to create their own profile, share a journal with others, and post to respective discussion forums.
In addition, core intervention components include distress monitoring, educational items, details about the healthcare team and an areas to keep track of questions for providers.
|
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활성 비교기: Control Group
Using the Usual Care Educational Website : a website which will contain information regarding ovarian cancer however it will not be interactive.
It will contain pdf documents of the material handed out in clinic (usual care).
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Using the control website: Participants access a website with standard ovarian cancer informational handouts.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Comparison of Number of Women Who Completed Advanced Directive
기간: Day 60 After Baseline
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Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.
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Day 60 After Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Comparison of Number of Women Who Report Appointment with Palliative Care
기간: Day 60 After Baseline
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Count of number of women with ovarian cancer who report an appointment with a Palliative Care specialist
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Day 60 After Baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Melissa A. Geller, M.D., Masonic Cancer Center, University of Minnesota
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2012NTLS005
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