Healing Touch and Health-Related Quality of Life in Women With Breast Cancer Receiving Radiation Therapy

NCT00612443 | Completed Phase 2

• 2 other identifiers: 07.0.24307-006400
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of Healing Touch to improve health-related quality of life in women with breast cancer receiving radiation therapy. Research Hypothesis Healing Touch significantly improves health-related quality of life when compared to a placebo treatment, among women receiving radiation therapy for treatment of breast cancer.

Conditions

Breast Neoplasms

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the difference in the FACT-B total score from baseline, midpoint and end of study participation.

  Measurement at study entrance, after 3 weeks and study exit (4, 5 or 6 weeks).

Secondary Outcomes (1)

• Secondary endpoints are the sub-scales of the FACT-B scores physical well- being, social/family well-being, emotional well-being, functional well-being,and breast cancer subscales)

  study entrance, after 3 weeks and at study exit

Study Arms (2)

1

EXPERIMENTAL

non-contact Healing Touch treatment for 20-30 minutes once a week during the course of radiation therapy

Behavioral: Healing Touch

2

SHAM COMPARATOR

A RN graduate assistant will provide a sham treatment of 20-30 minutes of presence.

Behavioral: Sham treatment

Interventions

Sham treatment BEHAVIORAL

The sham/placebo treatment will consist of the RN graduate assistant standing near the table, slowly walking around from each side and to the foot of the table stopping periodically. The RN graduate assistant will be instructed to not focus on the patient in thought. While providing the placebo treatment the RN graduate assistant will mentally do multiplication equations. This serves as a distracter to keep the RN graduate assistant from setting intention or thoughts on the participant. At no time will the RN performing the placebo treatment move hands or arms over or around the participant or come in physical contact with the participant. The placebo treatment will be a minimum of 20 minutes but no greater than 30 minutes in length. A timer will be set in the treatment room to notify the practitioner of the time limit.

Also known as: placebo treatment

2

Healing Touch BEHAVIORAL

Behavioral: Healing Touch The Healing Touch intervention will consist of a brief meditative state in which the practitioners sets the intention of healing for the session. A hand scan to assess the biofield; consists of a technique of where the practitioner slowly moves her hands three to six inches above the body going from head to toe, to assess for any disturbances in the biofield; a non-contact Healing Touch treatment which will follow, to include a connection of the chakras. The chakras are connected by placing the hands above the body over each chakra, starting at the feet and progressing to the head. This will be followed by smoothing the biofield, achieved by the Practitioner slowly moving her hands above the body from the head and moving towards the feet (Hover-Kramer et al., 1996). At no time will the Practitioner make physical contact with the participant during the treatment. The treatment will be 20 minutes to 30 minutes in length.

1

Eligibility Criteria

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

You may qualify if:

• Any female patient being treated with radiation therapy for a diagnosis of stage 0, I, or II breast cancer
• Aged 18 years or greater
• Understands written and spoken English
• receiving 4, 5 or 6 weeks of radiation are eligible with a minimum study enrollment time of 4 weeks.

You may not qualify if:

• Anyone not meeting the above

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Touch

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lisa L Schnepper, MSN, PhD (c)

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

• Laura M Anderko, PhD

  University of Wisconsin, Milwaukee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 11, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 21, 2009

Record last verified: 2008-01

Locations

US (1)