Grant Number:	5R01CA261881-05 Interpret this number
Primary Investigator:	Kadan-Lottick, Nina
Organization:	Georgetown University
Project Title:	Bridging Information Divides and Gaps to Ensure Survivorship: the Bridges Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Fiscal Year:	2025

More than 80% of childhood cancer survivors (CCS) develop serious or life-threatening late effects. Yet <20% of CCS receive recommended survivorship care, despite the availability of consensus guidelines for lifelong surveillance for late effects starting 2 years post-therapy. The “gold standard” cancer center-based survivorship clinic provides high-quality care to CCS who attend, but patients avoid reminders of their past cancer and lack knowledge and self-efficacy for survivorship care. Travel distance, inadequate insurance, and out-of-pocket costs are other barriers to survivorship care. Partnering with community primary care provider (PCP) clinics in a shared model of care is a promising strategy to overcome these barriers, but PCPs lack knowledge, self-efficacy, and interactive communication with the cancer center and are confused about the division of care responsibilities. Our intervention is scalable and distance-based, is informed directly by patient and PCP barriers and preferences from previous studies, and is boosted by a nationwide explosion in telehealth services. The proposed randomized controlled trial will enroll 240 CCS 2.0-4.0 years post-chemotherapy/radiation to investigate an innovative multi-level intervention (i.e., interpersonal and organizational levels) consisting of 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the EHR's patient portal, 3) a structured interactive phone communication between the cancer center and the PCP clinic (with 1-year follow-up call), and 4) an in-person visit with the PCP clinic for survivorship care. The comparison group will be randomized to an in-person visit with their cancer center survivorship clinic. This study is a collaboration of 4 centers with high proportions of subgroups with known barriers to survivorship care (i.e., rural, low income, underinsured). Both groups will be asked to begin recommended surveillance for late effects within 1-year post-randomization, separate from tumor recurrence monitoring by the primary oncologist. Our Specific Aims are to Aim 1- Demonstrate patient completion of guideline-recommended surveillance tests in intervention participants is not inferior, i.e. within 10%, to that in the comparison group; Aim 2- Achieve greater 1) patient knowledge, self-efficacy, and activation and 2) PCP knowledge and self-efficacy with survivorship care among intervention participants and their PCPs compared to the comparison group; and Aim 3- Ascertain process outcomes for the 1) patient and 2) PCP clinic. Outcomes will also be assessed among subgroups with barriers to survivorship care. Transformative Impact: If our intervention demonstrates patient completion of recommended survivorship care comparable to cancer center survivorship clinic, our study has the enormous potential to deliver recommended lifelong care to a larger proportion of CCS and reduce barriers to survivorship care, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health maintenance.





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