This revised proposal targets survivors with 2 of the most prevalent complications in adult long term survivors of hematopoietic stem cell transplantation (HSCT): fatigue and depression/distress. More than half of survivors have 1 or both of these complications. Needs of these geographically dispersed survivors can be best managed using Internet and phone modalities applying problem solving treatment along with physical and social activation. These treatment approaches have proven efficacious in studies with other populations, but have not been tested with HSCT survivors to our knowledge. This is a Phase ll-lll randomized controlled trial of N=300 adults 5-10 years after HSCT. Survivors are first screened to detect the targeted complications. Those with fatigue or depression/distress above set cutoff levels will be randomized and provided standardized treatment.
The specific aim i s to determine the efficacy of a randomized controlled trial to improve long term fatigue/physical dysfunction and depression/distress in adult 5-10 year HSCT survivors using an Internet and phone-based problem solving treatment as compared with an active nutrition control. Our primary hypothesis is that survivors with 1 or more targeted complications who are randomized to the treatment, compared with survivors randomized to nutrition control, will report fewer aggregate number of problems with fatigue, physical function, distress related to illness uncertainty and depression at 3 and 12 month outcome assessments. Our secondary hypothesis is that survivors in the subset with a targeted complication who are randomized to the intervention, compared with survivors randomized to nutrition control, will have improved outcome for that complication. As primary endpoints, we will compare groups on vitality (fatigue) and physical function on the SF36, depression on the SCL-90-R depression scale and an uncertainty distress measure. Assessment time points occur at baseline before randomization and outcomes at 3 and 12 months. This interdisciplinary research proposal integrates medical and bio-behavioral treatments in addressing the interrelated needs of long term survivors. While designed for HSCT long term survivors, the symptoms and diseases targeted are germane to survivors of other cancer treatments as well as to the expanding population of HSCT survivors.
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