The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being. The proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Sixty patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. In addition to obtaining estimates of efficacy, this Exploratory/Developmental Research Grant (R21) application also proposes several research design innovations to address critical methodological issues that have plagued prior studies of complementary and alternative medicine (CAM) interventions in general, and bodywork therapies, in particular. 1) Current quantitative assessment tools often fail to fully capture the nature and degree of change in highly subjective conditions and their impact on an individual's functioning and quality of life. We propose to add a novel qualitative research component to study changes in participants' perceptions of fatigue severity and its impact on their lives. 2) Most prior studies in bodywork interventions have failed to adequately control for the non-specific effects of the time spent with a practitioner and physical contact between the provider and participant. We propose to test a unique control condition (in addition to a usual-care control arm) to account for these effects. 3) Prior studies of bodywork therapies have neglected important psychological and sociocultural factors associated with subjects' participation and outcomes. We will examine these issues within the qualitative research component. 4) Because bodywork involves close personal physical contact, gender issues may complicate the provision and success of massage therapy. We will study these effects using qualitative methods, as well as a stratified randomization of gender-concordant and gender-discordant pairs to examine outcomes. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions.
| Patterson, Michael; Maurer, Stephanie; Adler, Shelley R et al. (2008) A novel clinical-trial design for the study of massage therapy. Complement Ther Med 16:169-76 |
