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.