A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy

Abstract

Purpose: This is a pilot study investigating the effect of healing touch (HT) on fatigue in breast cancer patients undergoing radiation therapy (RT).

Methods/design: This study presents the results of a within-subjects design randomized clinical trial where the treatment group was treated with HT, whereas the control group experienced sham therapy. The setting was a university RT clinic. The participants were breast cancer patients treated with lumpectomy or mastectomy, 21 to 75 years old with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. The intervention was a 45-minute session of HT or sham therapy once a week during RT. Outcome measures included fatigue, quality of life (QOL), and anxiety/depression.

Result: A total of 70 patients were approached, with 41 completing the study. At completion, the HT participants tended to report higher levels of fatigue, statistically significant for interference ( : = .010) and usual fatigue ( : = .024). The control group tended to report greater reductions in fatigue relative to their own means than the HT group (Cohen's : = 0.30 to 0.49 vs 0.06 to 0.18, respectively). There were no statistically significant differences between the groups for QOL.

Conclusion: Our enrollment and retention indicate that HT is feasible for women during RT. Our pilot findings do not support a beneficial effect of HT on fatigue or QOL. Future research may explore increasing dose and teasing out therapist effect.

Trial registration: ClinicalTrials.gov NCT00574145.

Keywords: breast cancer; depression; fatigue; healing touch; quality of life.