Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care
4 weeks
No
Suzanne C. Danhauer, PhD
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
CDR0000471996
NCT00321880
February 2006
October 2008
Name | Location |
---|---|
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |