Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer

Vanderbilt University Medical Center

Status: Completed

Conditions: Breast Cancer; Depression; Fatigue

Treatments: Procedure: psychosocial assessment and care; Procedure: therapeutic touch; Procedure: quality-of-life assessment; Procedure: Bio-field energy therapy; Procedure: fatigue assessment and management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00574145

VU-VICC-SUPP-0633

VICC SUPP 0633

Details and patient eligibility

About

RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast cancer who are undergoing radiation therapy.

PURPOSE: This randomized clinical trial is studying how well healing touch works in treating fatigue in women undergoing radiation therapy for breast cancer.

Full description

OBJECTIVES:

• To determine the ability to recruit and retain patients with breast cancer receiving curative radiotherapy in a Complementary and Alternative Medicine trial.
• To determine the acceptability of weekly healing touch therapy to patients with breast cancer who receive curative radiotherapy.
• To examine the effect of healing touch on fatigue and quality of life for patients with breast cancer receiving radiotherapy as a component of therapy.

OUTLINE: Patients are stratified by type of treatment (radiotherapy alone vs chemotherapy completed prior to radiotherapy)

• Arm I:Patients receive healing-touch therapy administered once a week for 45 minutes by a healing-touch therapist for the duration of radiotherapy.
• Arm II: Patients receive sham-therapy administered once a week for 45 minutes by a sham-practitioner (NOT a healing-touch therapist) for the duration of radiotherapy.

Patients complete the Hospital Anxiety and Depression Scale (HAD) and a demographic variables form (age, race/ethnicity, marital status, employment) at baseline. Patient fatigue is measured on a weekly basis throughout radiotherapy with completion of the Brief Fatigue Inventory (BFI). The Functional Assessment of Cancer Therapy-Breast form (FACT-B) is completed at baseline and the end of radiotherapy. Patients undergo a 20-minute interview at the end of study to determine the acceptability of the intervention.

Enrollment: 44 patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven breast cancer
• Receiving post lumpectomy or post mastectomy radiation therapy (RT)
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2
• Prescribed a minimum of 5 weeks of RT
• Between the ages of 21 and 75
• Able to speak English.
• Provides written informed consent

Exclusion criteria

• Documented active psychiatric illness
• Documented cognitive impairment that would preclude the ability to provide informed consent.
• Stage IV breast cancer
• Receiving concurrent chemotherapy and RT

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Radiotherapy/Supportive Care (A)

Experimental group

Description:

Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy

Treatment:

Procedure: quality-of-life assessment

Procedure: Bio-field energy therapy

Procedure: psychosocial assessment and care

Procedure: fatigue assessment and management

Procedure: therapeutic touch

Control ARM (B)

Sham Comparator group

Description:

Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy

Treatment:

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Procedure: fatigue assessment and management