Incorporating Patients' Perspectives in Complementary and Alternative Medicine Clinical Trial Design

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Abstract
Objectives: To describe the importance and process of gathering the perspectives of former patients when designing clinical studies for complementary and alternative medicine (CAM) therapies and to describe how this information was used to guide the planning of a clinical study using complementary modalities to reduce symptom distress and enhance quality of life during the autologous stem cell transplantation (ASCT) process. Design: Structured interviews with former ASCT patients to identify preferences, opinions, and other issues that may affect a clinical study in this population. Setting: University of Virginia Health System Stem Cell Transplant Clinic. Subjects: Ten (10) patients who had undergone ASCT within the previous year. Results: In general, the 10 study participants interviewed reported that they would have been more receptive to receiving gentle Swedish massage than using guided imagery tapes during the ASCT process, although neither modality would have been particularly welcome during those treatment phases with highest physical or emotional/mental stress. Personal experiences, treatment side-effects, "personality," and life situation all had an influence on not only what was considered most stressful for the patient but also why it was perceived as stressful. Conclusion: Eliciting the views of persons who have undergone significant medical events is a necessary step in rigorous clinical trial development aimed at testing the efficacy of CAM modalities for symptom management. Consideration of patient preferences and motivations may ensure the best fit between interventions and the desired outcomes.