Grant Number:	6R01CA215134-06 Interpret this number
Primary Investigator:	Baker, Kevin
Organization:	Fred Hutchinson Cancer Center
Project Title:	Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors After Hematopoietic Cell Transplantation
Fiscal Year:	2022

7. PROJECT SUMMARY/ABSTRACT By 2030, there will be an estimated half a million hematopoietic cell transplant (HCT) survivors in the US. HCT survivors have higher rates of late mortality and adverse effects compared to other cancer treatments. Long- term complications include high rates of cardiovascular disease, metabolic syndrome, and new cancers along with psychosocial difficulties including elevated cancer-related distress and depression. This proposal integrates, extends, and improves two successful HCT survivorship programs tested in randomized controlled trials (RCTs) and will fill a critical gap in care for HCT survivors by providing a novel, technology based survivorship care program to provide personalized self-management skills and interactive support. The proposed RCT will be offered to HCT survivors at the point of their greatest need as they transition away from close monitoring at their transplant centers. It will combine an online, social media and mobile application INSPIRE program, with a personalized and HCT-specific treatment summary and survivorship care plan (SCP). Informatics will integrate the data and study conduct resources of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the National Marrow Donor Program (NMDP). The specific aims are to: 1) Among HCT survivors with poor health care adherence to cardiometabolic or new cancer surveillance and/or elevated cancer-related distress, determine the impact of a patient-centered, self- management stepped care program compared to an active control group provided access to HCT survivorship best practices; 2) Determine characteristics of intervention participants who require telehealth stepped care at 1-month; and 3) Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR//NMDP (i.e., costs, level of expertise, and use of intervention components relative to costs). These aims will be accomplished in a multicenter RCT of N=980 2-5 year HCT survivors randomized to a self-management, stepped care program beginning with the online INSPIRE program plus a personalized SCP (electronically populated with existing CIBMTR data resources) and adding telehealth self-management for those who fail to improve after 1 month, versus an active control group provided access to the personalized SCP and a control website. Primary outcomes will be improved adherence to cardiometabolic and second cancer surveillance guidelines and distress at 12 months. The proposed intervention uses a sustainable informatics administration system for study management and intervention delivery, and potentially improves effect sizes of earlier studies by adding a larger ‘dose’ of the intervention through the addition of telehealth stepped care for those who do not respond to the online program alone. If the program demonstrates efficacy it could be readily implemented to improve the standard of care nationally for HCT survivors by leveraging the existing infrastructure of the CIBMTR/NMDP.

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