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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00321880

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

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 :

Feb 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Oct 1, 2008

Outcome Measures

Primary Outcome Measures

Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care [4 weeks]
Effectiveness of healing touch on reducing psychological stress and fatigue [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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