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  • INSPIRE: A Multicenter Randomized Controlled Trial Integrating health informatics in a scalable stepped care self-management program for survivors after hematopoietic cell transplantation

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2018-136
    NCT ID
    • NCT03125070
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Joseph
      Uberti, M.D., Ph.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Objective:
      To determine the efficacy of a multicenter RCT of a self-management survivorship intervention that includes a personalized mobile application that is cross-device enabled, with internet and social media options, including stepped care telehealth, for adult 2-5 year HCT survivors enrolled from national transplant centers.
  • Primary Aims
      1. Determine whether 2-5 year HCT survivors with elevated cancer-related distress or poor health care adherence, adherence to cardiometabolic or subsequent malignancy surveillance who are randomized to receive the online, patient-centered, self- management stepped care program will report reduced distress, and improved health care adherence for cardiometabolic or subsequent malignancy surveillance at 12 months when compared with an active control group who receive access to HCT survivorship best practices.
      2. Determine characteristics of intervention participants who require telehealth stepped care at 1-month, because they 1) do not meet criteria for adequate knowledge of subsequent malignancy and cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program.
      3. Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR//NMDP.
  • Secondary Aims
  • Secondary outcomes will include process measures of internet study reach and utilization, as well as depression, physical function, physical activity level, and knowledge of survivorship needs in HCT survivors.
    Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266