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Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue


N/A
21 Years
75 Years
Not Enrolling
Female
Breast Cancer, Depression, Fatigue

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Trial Information

Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Fatigue Using the Brief Fatigue Inventory (BFI)

Outcome Description:

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.

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Nancy Wells, DNSc, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC SUPP 0633

NCT ID:

NCT00574145

Start Date:

February 2007

Completion Date:

April 2009

Related Keywords:

  • Breast Cancer
  • Depression
  • Fatigue
  • 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
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064