Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
NCT ID: NCT00321880
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2006-02-28
2008-10-31
Brief Summary
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PURPOSE: This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Interventions
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therapeutic touch
administration of healing touch in 30 minute sessions
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Suzanne C. Danhauer, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU-02305
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-BG06-006
Identifier Type: -
Identifier Source: secondary_id
CDR0000471996
Identifier Type: -
Identifier Source: org_study_id
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