Presurgery Hypnosis in Breast Cancer: Benefits Analysis

Mount Sinai School Of Medicine Of Nyu, New York NY

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Abstract

DESCRIPTION (provided by applicant): Over 90% of the 211,300 women diagnosed with breast cancer in 2003 will undergo surgery as part of their curative treatment. Despite improvements in pharmacological management, surgical procedures under general anesthesia continue to be associated with clinically significant side effects, chief among which are pain and nausea. These clinical problems are particularly severe following surgical treatment for breast cancer and can require additional pharmacologic intervention, prolong recovery room stay, delay discharge, and lead to unanticipated readmission. Clinical research with other patient populations has indicated that presurgery hypnosis reduces intraoperative complications, postoperative symptoms, and enhances recovery. Preliminary data with breast surgery patients has revealed that a brief presurgery hypnosis with a psychologist can significantly improve post-surgery recovery relative to an attention control condition. Yet to be formally examined is the need for a "live" intervention by a professional: a critical question before translation to everyday clinical practice can be accomplished. Furthermore, the intervention may have long term "side benefits." The study goal is to establish the relative efficacy and cost of "live" and recorded presurgical hypnosis interventions in mastectomy patients. Study innovations include investigation of the effects of moderators and mediators on the differential group effects, as well as an exploration of the side benefits of the intervention for 12 months following surgery. The results of this original research proposal will speak to both clinical application and scientific understanding. The Specific Aims, are to: 1) Investigate the beneficial impact of "live" and recorded presurgical hypnosis interventions in women scheduled for breast cancer surgery; 2) Examine the effects of potential moderating variables of the hypnosis interventions on post-surgery side effects and recovery; 3) Determine whether the beneficial effects of the hypnosis intervention are accounted for (mediated) by differences in presurgery cognitive expectations and emotional distress; and 4) Investigate the possibility that the hypnosis intervention has side benefits for women facing breast cancer and its treatment. To achieve these Aims, 125 breast cancer mastectomy patients will be randomly assigned to 5 Groups. Groups differ on Surgery Day intervention (3 levels: "live" hypnosis session; recorded hypnosis session; control) and Hypnosis Practice Period (2 levels: Yes; No - Controls exempted) to determine the relative contributions of "live," recorded, and practice period presurgery hypnosis to reducing side effects and enhancing recovery. The design allows direct comparisons of both clinical impact and cost effectiveness of these interventions in a randomized clinical trial. Mediators and moderators (e.g., hypnotizability) of hypnosis effects will be determined, as well as long-term side benefits of the intervention.