- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01779063
Promoting Adherence to Lymphedema Self-care
Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors
Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong. Previous studies found that about half of breast cancer survivors with lymphedema do not complete self-care as directed. Feelings of being helpless to manage the condition, a desire to be normal, lack of noticeable results from self-care, and poor social/healthcare professional support are barriers to performing self-care on a regular basis. There is a need to develop and test interventions to promote effective self-care. Experts suggest the best self-care interventions should include patient perspectives and be available a readily accessible format. Technological advancements support use of innovative, creative approaches, such as Web-based multimedia interventions. Web-based interventions can be used in rural and urban settings. The investigators are proposing to develop a Web-based, multimedia intervention and a "take home" manual to support self-care in breast cancer survivors with lymphedema. The investigators plan to conduct focus groups with these survivors to determine the content and delivery format(s) and to help us identify breast cancer survivors with lymphedema for the video component. The investigators will then develop an intervention that will include self-care demonstrations and other supportive information to help patients to cope with the challenges of self-care. The focus groups will reconvene, review the intervention, and give us feedback on modifying and refining the intervention. After finalizing the intervention, The investigators will recruit more breast cancer survivors with lymphedema and provide one half of them an education booklet and the other half the Web-based intervention (or an alternative format such as DVD). Then, over 12 months, the investigators will periodically assess and compare both groups on self-care behaviors, physical and emotional concerns, and other issues such as money spent on lymphedema treatment. The group that receives the education booklet will be given access to the Web-based intervention after the 12 month follow-up is done, but the investigators will not ask them to complete any more forms.
This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals. By providing accessible, detailed self-care instructions and a psychosocial component, this intervention has the potential to improve lymphedema self-care. If successful, this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37072
- Vanderbilt Univeristy School Of Nursing
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- have a history of breast cancer;
- previous diagnosis of lymphedema;
- Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted);
- be age 18 or older;
- be able to see and read printed documents in English; and for stage 2 only,
- have access to the Internet or a smart phone.
Exclusion Criteria: will not be:
- undergoing chemotherapy or radiation, or
- receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: web based multimedia intervention
interactive,web based multimedia intervention
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cognitive therapy based web intervention
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활성 비교기: education booklet
printed educational booklet
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patient education booklet
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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symptom burden
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report of symptoms will be documented on study instruments
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change between baseline and 1, 3, 6, and 12 months post-intervention
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function
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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Self-report functional data using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
|
|
psychological well-being
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
|
change between baseline and 1, 3, 6, and 12 months post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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coping
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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self-care activities
기간: Change between baseline 1, 3, 6, and 12 months post-intervention
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self report using a self-care checklist
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Change between baseline 1, 3, 6, and 12 months post-intervention
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stress
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
|
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self-efficacy
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
|
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social support
기간: change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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extracellular fluid
기간: change between baseline and 3, 6, and 12 months post-intervention
|
bioelectrical impedence measurement for sub set of participants
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change between baseline and 3, 6, and 12 months post-intervention
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공동 작업자 및 조사자
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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