Developing Treatment and Control Conditions in a Clinical Trial of Massage Therapy for Advanced Cancer

Christine E. Lynn College of Nursing, Florida Atlantic University, Boca Raton, FL 33431, USA.
Journal of the Society for Integrative Oncology 09/2007; 5(4):139-46. DOI: 10.2310/7200.2007.014
Source: PubMed


The purpose of this article is to describe the challenges faced by a research team in developing treatment and control conditions in a study of the efficacy of massage therapy for advanced cancer. Five design considerations were addressed related to developing a massage therapy protocol: (1) dosage, that is, the number, spacing and length of treatments; (2) type of massage therapy; (3) degree to which the protocol for the treatment is standardized; (4) qualifications of the persons providing the treatment; and (5) conditions under which the treatment is provided. Five criteria for structuring the control condition of the study are elaborated: (1) equivalency of contact; (2) similarity of form; (3) minimum adverse or negative effects; (4) expectancy of therapeutic benefit; and (5) minimum therapeutic benefit.

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    • "An experimental, repeated-measures, crossover design study of 18 older cancer survivors residing in nursing homes was conducted from 2009–2011. This design was selected because it offered advantages over parallel group trials including: (a) that each subject acted has his or her own control, eliminating among-subject variation; (b) that fewer subjects were required to obtain the same power; (c) that every subject received both conditions [8]. Directors of nursing at 3 large nursing home facilities in Pennsylvania approached residents for permission to be contacted for the study. "
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    ABSTRACT: Small studies of variable quality suggest that massage therapy may relieve pain and other symptoms. To evaluate the efficacy of massage for decreasing pain and symptom distress and improving quality of life among persons with advanced cancer. Multisite, randomized clinical trial. Population-based Palliative Care Research Network. 380 adults with advanced cancer who were experiencing moderate-to-severe pain; 90% were enrolled in hospice. Six 30-minute massage or simple-touch sessions over 2 weeks. Primary outcomes were immediate (Memorial Pain Assessment Card, 0- to 10-point scale) and sustained (Brief Pain Inventory [BPI], 0- to 10-point scale) change in pain. Secondary outcomes were immediate change in mood (Memorial Pain Assessment Card) and 60-second heart and respiratory rates and sustained change in quality of life (McGill Quality of Life Questionnaire, 0- to 10-point scale), symptom distress (Memorial Symptom Assessment Scale, 0- to 4-point scale), and analgesic medication use (parenteral morphine equivalents [mg/d]). Immediate outcomes were obtained just before and after each treatment session. Sustained outcomes were obtained at baseline and weekly for 3 weeks. 298 persons were included in the immediate outcome analysis and 348 in the sustained outcome analysis. A total of 82 persons did not receive any allocated study treatments (37 massage patients, 45 control participants). Both groups demonstrated immediate improvement in pain (massage, -1.87 points [95% CI, -2.07 to -1.67 points]; control, -0.97 point [CI, -1.18 to -0.76 points]) and mood (massage, 1.58 points [CI, 1.40 to 1.76 points]; control, 0.97 point [CI, 0.78 to 1.16 points]). Massage was superior for both immediate pain and mood (mean difference, 0.90 and 0.61 points, respectively; P < 0.001). No between-group mean differences occurred over time in sustained pain (BPI mean pain, 0.07 point [CI, -0.23 to 0.37 points]; BPI worst pain, -0.14 point [CI, -0.59 to 0.31 points]), quality of life (McGill Quality of Life Questionnaire overall, 0.08 point [CI, -0.37 to 0.53 points]), symptom distress (Memorial Symptom Assessment Scale global distress index, -0.002 point [CI, -0.12 to 0.12 points]), or analgesic medication use (parenteral morphine equivalents, -0.10 mg/d [CI, -0.25 to 0.05 mg/d]). The immediate outcome measures were obtained by unblinded study therapists, possibly leading to reporting bias and the overestimation of a beneficial effect. The generalizability to all patients with advanced cancer is uncertain. The differential beneficial effect of massage therapy over simple touch is not conclusive without a usual care control group. Massage may have immediately beneficial effects on pain and mood among patients with advanced cancer. Given the lack of sustained effects and the observed improvements in both study groups, the potential benefits of attention and simple touch should also be considered in this patient population.
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