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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sham treatment
Healing Touch
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Anyone not meeting the above

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
January 25, 2008
Last Updated
January 20, 2009
Sponsor
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT00612443
Brief Title
Healing Touch and Health-Related Quality of Life in Women With Breast Cancer Receiving Radiation Therapy
Official Title
Healing Touch and Health-Related Quality of Life in Women With Breast Cancer in Women With Breast Cancer Receiving Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Wisconsin, Milwaukee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Purpose/objective The purpose of this study is to evaluate the efficacy of the CAM biofield therapy of Healing Touch to improve health-related quality of life (HRQOL) in women with breast cancer receiving radiation therapy. The proposed study will build on existing research by Cook, Guerrio and Slater (2004) who studied Healing Touch and HRQOL in women receiving radiation therapy for breast and gynecologic cancers. Outcome measures of HRQOL as measured by Short Form-36 (SF-36) tool were used (Norris et al. 2004). The SF-36 is a tool to measure HRQOL, a 36 item tool that measures nine domains of health: a) functional limitations in physical activity secondary to health problems, b) limitations in social activity secondary to physical or mental health issues, c) limitation in role activities secondary to physical health problems, d) limitation in role activities secondary emotional health problems, e) to pain, f) overall mental health, g) vitality, h) perceptions of health and i) health transitions (Norris et. al., 2004). Measurements were taken at baseline and end of study. Cook et al (2004) found that all women in the study had improved scores on the HRQOL Short Form-36 (SF-36) tool used (Norris et al. 2004). Equally important, the women who received Healing Touch had greater improvement in all subscale scores in comparison to placebo treatment. The overall score on the SF-36 (p value .00) and areas of emotional role functioning (p value .00), mental health (p value .03) and health transitions (p value .00) had statistical significance in the Healing Touch treatment group. The placebo treatment group had statistical significance in the areas of physical role functioning (p value .00) and health transition (p value .01).In group comparisons of mean SF-36 scores, the Healing Touch group had statistically greater improvement, than the placebo group, with a p value of < .05, in the areas of physical functioning, pain and vitality. The total number of participants in the study was 62 women, with 38 who had gynecologic cancers and 24 participants with breast cancer. The number of breast cancer patients was inadequate to perform a separate statistical analysis of this sub-group (Cook et al., 2004). Therefore, this study will specifically focus on women with breast cancer to investigate the efficacy of using Healing Touch to improve HRQOL improvement in women with breast cancer receiving radiation therapy. Research Aims The research aim of the proposed study is to determine the efficacy of Healing Touch in significantly improving HRQOL, as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)(Brady et al., 1997; Cella et al., 1993) scale among women receiving radiation therapy for breast cancer treatment (see Appendix A for FACT-B; see Appendix B for FACT-B scoring). Research Hypothesis Healing Touch significantly improves HRQOL, as measured by the FACT-B, when compared to a placebo treatment, among women receiving radiation therapy for treatment of breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
non-contact Healing Touch treatment for 20-30 minutes once a week during the course of radiation therapy
Arm Title
2
Arm Type
Sham Comparator
Arm Description
A RN graduate assistant will provide a sham treatment of 20-30 minutes of presence.
Intervention Type
Behavioral
Intervention Name(s)
Sham treatment
Other Intervention Name(s)
placebo treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healing Touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure is the difference in the FACT-B total score from baseline, midpoint and end of study participation.
Time Frame
Measurement at study entrance, after 3 weeks and study exit (4, 5 or 6 weeks).
Secondary Outcome Measure Information:
Title
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)
Time Frame
study entrance, after 3 weeks and at study exit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Anyone not meeting the above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa L Schnepper, MSN, PhD (c)
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura M Anderko, PhD
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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