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Clinical Trials/NCT00321880
NCT00321880
Completed
N/A

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

Wake Forest University Health Sciences1 site in 1 country40 target enrollmentFebruary 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fatigue
Sponsor
Wake Forest University Health Sciences
Enrollment
40
Locations
1
Primary Endpoint
Effectiveness of healing touch on reducing psychological stress and fatigue
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
October 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Effectiveness of healing touch on reducing psychological stress and fatigue

Time Frame: 4 weeks

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

Time Frame: 4 weeks

Study Sites (1)

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