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临床试验/NCT00321880
NCT00321880已完成不适用

Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Effectiveness of healing touch on reducing psychological stress and fatigue

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

结局指标

主要结局

Effectiveness of healing touch on reducing psychological stress and fatigue

时间窗: 4 weeks

Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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