Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
  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: Open Label
Primary Purpose: Supportive Care
Official Title: Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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 ]
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)
Intervention Details:
    Procedure: therapeutic touch
    administration of healing touch in 30 minute sessions
Detailed Description:

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 and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321880

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Suzanne C. Danhauer, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Responsible Party: Comprehensive Cancer Center of Wake Forest University
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: July 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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 30, 2016