Developing treatment and control conditions in a clinical trial of massage therapy for advanced cancer.
ABSTRACT 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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ABSTRACT: Therapeutic massage has been proven to be an effective, nonpharmacologic, alternative for managing state and trait anxiety in a variety of clinical situations. However, no controlled study has investigated this effect in an addiction treatment setting. The aim of this study was to investigate the effectiveness of chair massage for reducing anxiety in persons participating in an inpatient withdrawal management program for psychoactive drugs. The design was a randomized, controlled clinical trial conducted from June 2008 to January 2009. Eighty-two (82) adult patients received inpatient treatment for psychoactive drug withdrawal (alcohol, cocaine, and opiates). This study was conducted at the Withdrawal Management Services at the Capital District Health Authority, Halifax, Nova Scotia. Subjects were randomly assigned to receive chair massage (n = 40) or a relaxation control condition (n = 42). Treatments were offered for 3 consecutive days. Standard counseling and pharmacologic management were also offered concurrently to patients in all conditions. The primary outcome measure was anxiety assessed using the Spielberger State-Trait Anxiety Inventory (STAI). State and trait anxiety scores were determined immediately prior to and following each treatment intervention. Analysis of STAI scores showed a significant reduction in state and trait anxiety for both interventions (p < 0.001). The magnitude in the reduction in state (p = 0.001) and trait (p = 0.045) anxiety was significantly greater in the chair massage group where the effect on state anxiety was sustained, at least in part, for 24 hours. Within the clinical context of this study, chair massage was more effective that relaxation control in reducing anxiety. Further investigation of chair massage as a potential nonpharmacologic adjunct in the management of withdrawal related anxiety is warranted.Journal of alternative and complementary medicine (New York, N.Y.) 09/2010; 16(9):979-87. · 1.69 Impact Factor
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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.Annals of internal medicine 09/2008; 149(6):369-79. · 13.98 Impact Factor
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ABSTRACT: Researchers conducting multi-site studies of interventions for end-of-life symptom management face significant challenges with respect to obtaining an adequate sample and training and retaining on-site study teams. The purpose of this paper is to describe the strategies and responses to these challenges in a multi-site randomized clinical trial (RCT) of the efficacy of massage therapy for decreasing pain among patients with advanced cancer in palliative care/hospice settings. Over a period of 36 months, we enrolled 380 participants across 15 sites; 27% of whom withdrew prior to study completion (less than the anticipated 30% rate). We saw an average of 68% turnover amongst study staff. Three key qualities characterized successful on-site study teams: (1) organizational commitment; (2) strong leadership from on-site study coordinators; and (3) effective lines of communication between the on-site study coordinators and both their teams and the university-based research team. Issues of recruitment, retention and training should be accounted for in hospice-based research study design and budgeting.Journal of palliative medicine 06/2010; 13(6):739-44. · 1.84 Impact Factor