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OpenTrials
Completed

NCT Number: NCT00574145

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

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.

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Key information

Conditions

Breast Cancer Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bio-field energy therapy

Procedure

Practitioner's hands to influence the human energy field surrounding the patient's body.

Other names: biofield therapy

fatigue assessment and management

Procedure

duration

psychosocial assessment and care

Procedure

duration

quality-of-life assessment

Procedure

duration

therapeutic touch

Procedure

Practitioner's hands to influence the human energy field surrounding the patient's body

Primary outcomes

  1. Fatigue Using the Brief Fatigue Inventory (BFI)

    Time frame: 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 outcomes

  1. Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)

    Time frame: 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

  2. Intensity of Anxiety and Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2007
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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