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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Lisa L Schnepper, MSN, PhD (c)

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Milwaukee

Authority:

United States: Institutional Review Board

Study ID:

07.0.243

NCT ID:

NCT00612443

Start Date:

January 2008

Completion Date:

December 2008

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905