INSPIRE for Survivorship After Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-media Program for Long-term Hematopoietic Cell Transplantation Survivors
I. Determine whether 2-10 year hematopoietic cell transplant (HCT) survivors with elevated
depression or cancer-related distress who are randomized to receive access to a tailored
internet-based program report reduced depression and distress when compared with control
group survivors who receive access to an internet site with links to transplant and
cancer-specific online resources and delayed access to the internet site (active control).
II. Determine whether survivors with low survivorship preventive care adherence (PCA) who
are randomized to receive access to the tailored internet-based program, including a
survivorship preventive care plan, report increased PCA when compared with the active
control group survivors.
I. Secondary outcomes will include process measures of internet study reach and utilization,
as well as physical function, physical activity level, and knowledge of survivorship needs.
Further analyses will identify risk factors for disparities in survivorship preventive care
adherence in HCT survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants receive full access to the INSPIRE internet site comprising a an
individually tailored program with a greeting home page with links to each target area,
self-care tips and tool pages for each complication and major issues for HCT survivors, a
section for each complication (mood, energy, heart health, strengthening bones, second
cancers), a discussion board for input from other survivors, resource pages, opportunities
to send secure messages with questions or comments on any topic, opportunities to request
additional assistance or information, mobile texting options, and social media links.
ARM II: Participants receive website links to existing transplant and cancer survivor sites,
followed by delayed access to the INSPIRE internet program after 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
PHQ-8 depression score as reported on the PCA, using binary outcomes
Up to 12 months
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of Pennsylvania Medical Center||Philadelphia, Pennsylvania 19104|