Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00321880|
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Leukemia Psychosocial Effects of Cancer and Its Treatment||Procedure: therapeutic touch||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||October 2008|
- Procedure: therapeutic touch
administration of healing touch in 30 minute sessions
- Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care [ Time Frame: 4 weeks ]
- Effectiveness of healing touch on reducing psychological stress and fatigue [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321880
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Suzanne C. Danhauer, PhD||Wake Forest University Health Sciences|