Developing treatment and control conditions in a clinical trial of massage therapy for advanced cancer.
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.
Smith
Marlaine
M
Christine E. Lynn College of Nursing, Florida Atlantic University, Boca Raton, FL 33431, USA.
Kutner
Jean
J
Hemphill
Linnea
L
Yamashita
Traci
T
Felton
Susanne
S
D002986:Clinical Trials as Topic; D018450:Disease Progression; D006801:Humans; D008405:Massage; D009369:Neoplasms / Q000150:complications* / Q000523:psychology / Q000628:therapy; D010146:Pain / Q000209:etiology / Q000523:psychology; D059408:Pain Management; D010166:Palliative Care; D013548:Sweden