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Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00321880
First received: May 2, 2006
Last updated: July 11, 2012
Last verified: July 2012
History of Changes

May 2, 2006
July 11, 2012
February 2006
February 2007   (final data collection date for primary outcome measure)
  • Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Effectiveness of healing touch on reducing psychological stress and fatigue [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00321880 on ClinicalTrials.gov Archive Site
Not Provided
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Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study

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.

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
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Fatigue
  • Leukemia
  • Psychosocial Effects of Cancer and Its Treatment
Procedure: therapeutic touch
administration of healing touch in 30 minute sessions
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2008
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00321880
CDR0000471996, CCCWFU-02305, CCCWFU-BG06-006
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Suzanne C. Danhauer, PhD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP