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

• ClinicalTrials.gov Identifier: NCT00574145
• Recruitment Status: Completed
• First Posted: December 17, 2007
• Results First Posted: September 6, 2012
• Last Update Posted: September 6, 2012
• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Nancy Wells, Vanderbilt-Ingram Cancer Center

Tracking Information

• First Submitted Date: December 14, 2007
• First Posted Date: December 17, 2007
• Results First Submitted Date: March 15, 2012
• Results First Posted Date: September 6, 2012
• Last Update Posted Date: September 6, 2012
• Study Start Date: February 2007
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2012)

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.

Original Primary Outcome Measures (submitted: December 14, 2007)

• Recruitment and retention data
• Responses to the open-ended questions included in the interview at the end of the study
• Correlation of demographic data with fatigue as measured by the Brief Fatigue Inventory (BFI) weekly
• Correlation of demographic data with quality of life as measured by the Functional Assessment of Cancer Therapy-Breast form (FACT-B) at baseline and the end of radiotherapy
• Correlation of demographic data with anxiety and depression as measure by the Hospital Anxiety and Depression Scale (HAD)

Current Secondary Outcome Measures (submitted: August 4, 2012)

• 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
• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Breast Cancer
• Depression
• Fatigue

Intervention

• Procedure: Bio-field energy therapy
  Practitioner's hands to influence the human energy field surrounding the patient's body.
  Other Name: biofield therapy
• Procedure: fatigue assessment and management
  duration
• Procedure: psychosocial assessment and care
  duration
• Procedure: quality-of-life assessment
  duration
• Procedure: therapeutic touch
  Practitioner's hands to influence the human energy field surrounding the patient's body

Study Arms

• Experimental: Radiotherapy/Supportive Care (A)
  Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
  Interventions:

  • Procedure: Bio-field energy therapy
  • Procedure: fatigue assessment and management
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic touch
• Sham Comparator: Control ARM (B)
  Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy
  Interventions:

  • Procedure: fatigue assessment and management
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2012): 44
• Original Enrollment (submitted: December 14, 2007): 48
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00574145
• Other Study ID Numbers: VICC SUPP 0633; VU-VICC-SUPP-0633
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nancy Wells, Vanderbilt-Ingram Cancer Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: Vanderbilt-Ingram Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Nancy Wells, DNSc, RN; Vanderbilt-Ingram Cancer Center
• Principal Investigator: Fern Fitzhenry, PhD, RN; Vanderbilt-Ingram Cancer Center

• PRS Account: Vanderbilt-Ingram Cancer Center
• Verification Date: August 2012