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Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
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Purpose
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 | Intervention |
|---|---|
| Fatigue Leukemia Psychosocial Effects of Cancer and Its Treatment | Procedure: therapeutic touch |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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 ]
| Enrollment: | 40 |
| Study Start Date: | February 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
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Procedure: therapeutic touch
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.
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00321880 History of Changes |
| Other Study ID Numbers: |
CDR0000471996 CCCWFU-02305 CCCWFU-BG06-006 |
| Study First Received: | May 2, 2006 |
| Last Updated: | May 25, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Wake Forest University Health Sciences:
|
fatigue psychosocial effects of cancer and its treatment adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) |
adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Fatigue |
Neoplasms by Histologic Type Neoplasms Signs and Symptoms |
ClinicalTrials.gov processed this record on September 21, 2017