Clinical trial NCT00574145: Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
Official title: Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Depression
Fatigue
Keywords: fatigue
depression
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent breast cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-12-17
Enrollment: 44
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Using the Brief Fatigue Inventory (BFI)
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)
timeFrame: baseline and 6 weeks
measure: Intensity of Anxiety and Depression
timeFrame: baseline and off-radiation at 5 to 7 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Nancy Wells, DNSc, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt-Ingram Cancer Center
name: Fern Fitzhenry, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: FitzHenry F, Wells N, Slater V, Dietrich MS, Wisawatapnimit P, Chakravarthy AB. A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy. Integr Cancer Ther. 2014 Mar;13(2):105-13. doi: 10.1177/1534735413503545. Epub 2013 Oct 7.