Complementary Therapies for Children Undergoing Stem Cell Transplantation Report of a Multisite Trial

BACKGROUND: Children undergoing stem cell transplant (SCT) experience high levels of somatic distress and mood disturbance. This trial evaluated the efficacy of complementary therapies (massage, humor therapy, relaxation/imagery) for reducing distress associated with pediatric SCT. METHODS: Across 4 sites, 178 pediatric patients scheduled to undergo SCT were randomized to a child-targeted intervention involving massage and humor therapy, the identical child intervention plus a parent intervention involving massage and relaxation/imagery, or standard care. Randomization was stratified by site, age, and type of transplant. The interventions began at admission and continued through SCT Week +3. Primary outcomes included patient and parent reports of somatic distress and mood disturbance obtained weekly from admission through Week +6 using the Behavioral, Affective, and Somatic Experiences Scales. Secondary outcomes included length of hospitalization, time to engraftment, and usage of narcotic analgesic and antiemetic medications. RESULTS: A mixed model approach was used to assess longitudinal trends of patient and parent report outcomes and to test differences between groups on these measures. Significant changes across time were observed on all patient and parent report outcomes. However, no significant differences between treatment arms were found on the primary outcomes. Similarly, no significant between-group differences were noted on any of the medical variables as secondary outcomes. CONCLUSIONS: Results of this multisite trial failed to document significant benefits of complementary interventions in the pediatric SCT setting. Cancer 2010;116:3924-33. (C) 2010 American Cancer Society.