Clinical trial NCT00612443: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Neoplasms
Keywords: breast cancer
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The primary outcome measure is the difference in the FACT-B total score from baseline, midpoint and end of study participation.
timeFrame: Measurement at study entrance, after 3 weeks and study exit (4, 5 or 6 weeks).
Secondary outcomes:
measure: 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)
timeFrame: study entrance, after 3 weeks and at study exit
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Lisa L Schnepper, MSN, PhD (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Milwaukee
name: Laura M Anderko, PhD
role: STUDY_CHAIR
References: