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

• ClinicalTrials.gov Identifier: NCT00321880
• Recruitment Status: Completed
• First Posted: May 4, 2006
• Last Update Posted: May 30, 2017
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: May 2, 2006
• First Posted Date: May 4, 2006
• Last Update Posted Date: May 30, 2017
• Study Start Date: February 2006
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 11, 2012)

• 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 ]

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
• Official Title: Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Fatigue
• Leukemia
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure: therapeutic touch

administration of healing touch in 30 minute sessions

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 8, 2006): 40
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00321880
• Other Study ID Numbers: CDR0000471996; CCCWFU-02305; CCCWFU-BG06-006
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wake Forest University Health Sciences
• Original Responsible Party: Not Provided
• Current Study Sponsor: Wake Forest University Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Suzanne C. Danhauer, PhD; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: July 2012