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

Not Applicable

Completed

• Conditions: Breast Cancer; Depression; Fatigue
• Interventions: Procedure: Bio-field energy therapy; Procedure: fatigue assessment and management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Procedure: therapeutic touch

• Registration Number: NCT00574145
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2012-03-15
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-04
• Last Update Submitted: 2012-08-04
• Results First Posted: 2012-09-06
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy/Supportive Care (A)	Bio-field energy therapy	Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
Radiotherapy/Supportive Care (A)	fatigue assessment and management	Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
Radiotherapy/Supportive Care (A)	psychosocial assessment and care	Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
Radiotherapy/Supportive Care (A)	quality-of-life assessment	Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
Radiotherapy/Supportive Care (A)	therapeutic touch	Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
Control ARM (B)	fatigue assessment and management	Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy
Control ARM (B)	psychosocial assessment and care	Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy
Control ARM (B)	quality-of-life assessment	Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy

Primary Outcome Measures

Name	Time	Method
Fatigue Using the Brief Fatigue Inventory (BFI)	6 weeks	9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.

Secondary Outcome Measures

Name	Time	Method
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)	baseline and 6 weeks	36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined
Intensity of Anxiety and Depression	baseline and off-radiation at 5 to 7 weeks	Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints.

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States