- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00321880
Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study
RATIONALE: Supportive care, such as healing touch, may improve quality of life in patients receiving chemotherapy for acute leukemia.
PURPOSE: This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.
연구 개요
상세 설명
OBJECTIVES:
- Determine the feasibility of conducting a randomized controlled trial, in terms of recruiting and retaining participants, to a study of healing touch (HT) as supportive care in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.
- Examine potential barriers to participation and ascertain reasons for study drop-outs in these patients.
- Demonstrate whether these patients will comply with treatment sessions and remain in the study.
- Obtain preliminary data on the effectiveness of HT on psychological distress and treatment-related symptoms focusing on fatigue and sleep disturbances in these patients.
- Determine if the HT protocol needs to be refined, modified, or eliminated, based on pilot participant feedback, for a randomized clinical trial.
OUTLINE: This is a pilot study.
Within 1 week of admission to the hospital, patients are interviewed by a research assistant about previous use of complementary or alternative medicine therapies, knowledge of healing touch (HT), previous experience with HT, willingness to participate in a study of HT for acute leukemia patients, and willingness to be randomized in a HT study. The first 12 patients interested in undergoing HT undergo a 30-minute session of HT therapy 3 times a week during weeks 2, 3, and 4 of induction or reinduction chemotherapy. Patients are also asked to rate current distress, pain, fatigue, and nausea before and after the second HT session during weeks 2, 3, and 4. Patients also complete self-report questionnaires at baseline, during week 5 of induction or reinduction chemotherapy or prior to discharge from the hospital, and during the first week of consolidation chemotherapy (approximately week 9-13).
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of one of the following acute leukemias:
- Acute lymphocytic leukemia
- Acute myeloid leukemia
- Hospitalized for induction (newly diagnosed patients) or reinduction (relapsed patients) chemotherapy
- Must be oncology inpatients at Wake Forest University Baptist Medical Center
PATIENT CHARACTERISTICS:
- Must know adequate English to understand the consent form, complete questionnaires, and converse with study staff
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care
기간: 4 weeks
|
4 weeks
|
|
Effectiveness of healing touch on reducing psychological stress and fatigue
기간: 4 weeks
|
4 weeks
|
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000471996
- CCCWFU-02305
- CCCWFU-BG06-006
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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