Research methodology in psychoneuroimmunology: rationale and design of the IMAGES-P clinical trial.

Although mental imagery has historically been ignored by the scientific community, it is one of the six most commonly used alternative therapies chosen by cancer patients. Investigations of immune response to psychosocial interventions have been largely anecdotal or quasi-experimental. Although reports of increased survival predominate among cancer patients, few investigators have measured psychological or immunological outcomes to explain the mechanisms that contribute to improved survival. The efficacy of imagery or support groups in patient adaptation (emotionally and physically) to the stresses of cancer, heightened immune function, and improved morbidity and mortality remain uncertain in the absence of objective evidence from randomized, controlled clinical trials. The imagery and group emotional support study pilot (IMAGES-P) is a 12-month feasibility study designed to examine the effect of group support and imagery/relaxation in a randomized, controlled clinical trial, differentiating the effects of these therapy modalities on immune function, quality of life, and the emotional well-being of women who have completed treatment for breast cancer. Secondary aims are to explore the quantitative relationships among emotional well-being, quality of life, and immune function. For this study established clinical trial methodology was used to examine functional immune responses associated with emotional states induced by the therapy interventions. As a pilot study, IMAGES-P will provide direction for future longitudinal studies evaluating the effectiveness of these interventions on emotional well-being and survival.