Title

Communicating health information and improving coordination with primary care (CHIIP): Rationale and design of a randomized cardiovascular health promotion trial for adult survivors of childhood cancer

Authors

Eric J. Chow, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA, United States of America. Electronic address: ericchow@uw.edu.
Laura-Mae Baldwin, Department of Family Medicine, University of Washington, Seattle, WA, United States of America.
Anna M. Hagen, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
Melissa M. Hudson, Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States of America; Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Todd M. Gibson, Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Komal Kochar, Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Aaron McDonald, Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Paul C. Nathan, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Karen L. Syrjala, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
Sarah L. Taylor, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
Emily S. Tonorezos, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America.
Yutaka Yasui, Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Gregory T. Armstrong, Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.
Kevin C. Oeffinger, Department of Medicine, Duke University, Durham, NC, United States of America.

Abstract

BACKGROUND: Long-term survival for children diagnosed with cancer exceeds 80%. Notably, premature cardiovascular disease has become the leading non-cancer cause of late mortality among these survivors. METHODS/DESIGN: This randomized controlled trial (RCT; NCT03104543) focuses on adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment. Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes. Those with abnormal values are then enrolled in an RCT to test the efficacy of a 12-month personalized, remotely delivered survivorship care plan (SCP) intervention designed to reduce undertreatment of these three target conditions. The intervention approximates a clinical encounter and is based on chronic disease self-management strategies. RESULTS: With a goal of 750, currently 342 out of 742 eligible participants approached have enrolled (46.1%). Initially, we randomized participants to different recruitment strategies, including shorter approach packets and a tiered consent, but did not find significant differences in participation rates (40.7% to 42.9%; p = .95). Subsequently, slightly greater participation was seen with larger upfront unconditional incentive checks ($50 vs. $25: 50.7% vs. 44.1%; p = .10). Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive. CONCLUSION: The overall study will determine if a National Academy of Medicine-recommended SCP intervention can improve cardiovascular outcomes among long-term survivors of childhood cancer. Modifications to the recruitment strategy may improve participation rates over time.

Publication Title

Contemporary clinical trials

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