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

NCT00574145 | Completed Results DMC

• 2 other identifiers: VICC SUPP 0633VU-VICC-SUPP-0633
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Fatigue Using the Brief Fatigue Inventory (BFI)

  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.

  6 weeks

Secondary Outcomes (2)

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

  baseline and 6 weeks

• Intensity of Anxiety and Depression

  baseline and off-radiation at 5 to 7 weeks

Study Arms (2)

Radiotherapy/Supportive Care (A)

EXPERIMENTAL

Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy

Procedure: Bio-field energy therapy; Procedure: fatigue assessment and management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Procedure: therapeutic touch

Control ARM (B)

SHAM COMPARATOR

Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy

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

Interventions

Bio-field energy therapy PROCEDURE

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

Also known as: biofield therapy

Radiotherapy/Supportive Care (A)

fatigue assessment and management PROCEDURE

duration

Control ARM (B); Radiotherapy/Supportive Care (A)

psychosocial assessment and care PROCEDURE

duration

Control ARM (B); Radiotherapy/Supportive Care (A)

quality-of-life assessment PROCEDURE

duration

Control ARM (B); Radiotherapy/Supportive Care (A)

therapeutic touch PROCEDURE

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

Radiotherapy/Supportive Care (A)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

• 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.

  PMID: 24105358 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Depression; Fatigue

Interventions

Therapeutics; Psychiatric Rehabilitation; Therapeutic Touch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies

Results Point of Contact

• Title: Nancy Wells, DNSc., R.N
• Organization: Vanderbilt-Ingram Cancer Center

nancy.wells@vanderbilt.edu

615-322-6184

Study Officials

• Nancy Wells, DNSc, RN

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

• Fern Fitzhenry, PhD, RN

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Nursing; Director, VUMC Nursing

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 6, 2012
• Results First Posted: September 6, 2012

Record last verified: 2012-08

Locations

US (3)