A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
BRIDGES
BRidging Information Divides and Gaps to Ensure Survivorship: the BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
1 other identifier
interventional
240
1 country
4
Brief Summary
More than 80% of childhood cancer survivors develop serious or life-threatening late effects after cancer therapy, but \<20% receive recommended survivorship care offered at cancer center survivorship clinics. In a shared care model, the investigators propose to investigate an innovative multi-level intervention consisting of: 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record patient portal, 3) a structured interactive phone communication between the cancer center and the primary care clinic, and 4) an in-person visit with the primary care clinic for survivorship care with the goal of achieving high rates of adherence to recommended surveillance for late effects, as well as improving patient and physician knowledge and self-efficacy. If this scalable intervention demonstrates patient completion of recommended care comparable to cancer center survivorship clinics, this innovative study has the enormous potential to deliver recommended care to a larger proportion of childhood cancer survivors and reduce survivorship care disparities, while engaging p to integrate survivorship care as part of overall, lifelong health maintenance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedAugust 20, 2025
August 1, 2025
3.2 years
June 16, 2022
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient completion of guideline-recommended surveillance tests for late effects of therapy
The investigators will assess adherence to surveillance recommended by the Children's Oncology Group Long-term Follow-up Guidelines. The primary analysis will be on tests completed by patients, and not just ordered by physicians, because that is the most meaningful indicator of patient adherence to guidelines
1-year post-randomization
Patient completion of guideline-recommended surveillance tests for late effects of therapy
The investigators will assess adherence to surveillance recommended by the Children's Oncology Group Long-term Follow-up Guidelines. The primary analysis will be on tests completed by patients, and not just ordered by physicians, because that is the most meaningful indicator of patient adherence to guidelines
2 years post-randomization
Secondary Outcomes (10)
Patient Knowledge:
1-year post-randomization
Patient Knowledge:
2-years post-randomization
Patient Healthcare Self-Efficacy
1-year post-randomization
Patient Healthcare Self-Efficacy
2-years post-randomization
Patient Activation
1-year post-randomization
- +5 more secondary outcomes
Other Outcomes (1)
Post-intervention qualitative interviews of participants and PCPs
1-year post-randomization
Study Arms (2)
Multi-level Intervention of shared model of survivorship care
EXPERIMENTAL1. Patient survivorship education via telehealth with the cancer center 2. Ongoing patient-tailored education program by MyChart within the EHR patient portal 3. Structured interactive phone communication between the research RN at the cancer center and community PCP clinic 4. In-person visit with the PCP clinic for survivorship care.
"Gold standard" cancer center-based survivorship clinic
ACTIVE COMPARATORIn-person visit at specialty survivorship clinic
Interventions
1\) Patient survivorship education via telehealth with the cancer center- The research registered nurse (RN) will discuss the contents of the survivorship care plan and coordination between the cancer center and PCP clinic. 2) Ongoing patient-tailored education program by MyChart within the EHR patient portal- Patients will be asked to select survivorship topics of interest from a panel (e.g. school issues, fertility, fatigue, physical activity, single kidney health, emotions/coping) that will then be sent over 1 year. 3) Structured interactive phone communication between the research RN at the cancer center and community PCP clinic- The discussion will explain the patient's cancer history, tumor recurrence monitoring schedule, individualized risk of late effects and surveillance schedule, psychosocial challenges, health behaviors, and coordination between the cancer center and PCP clinic. 4) In-person visit with the PCP clinic for survivorship care.
Participants will be contacted by study staff at their cancer center to schedule an in-person visit at the survivorship clinic that will include a comprehensive history focused on cancer-related medical and psychosocial issues, physical examination, ordering of recommended surveillance for late effects, and delivery of hard copy of their survivorship care plan.
Eligibility Criteria
You may qualify if:
- Diagnosed with any cancer at age \<21 years
- Treated with chemotherapy and/or radiation
- years status post-completion of all cancer-related therapy
- Cancer-free with a life expectancy of ≥2 years
- English- or Spanish-speaking (also applies to parent/guardian if patient age \<18 years)
- No previous attendance at a specialty survivorship clinic
- Followed at one of the 4 participating sites: Hackensack, University of North Carolina- Chapel Hill (UNC), University of Colorado Denver (CU), Miller's Children's and Women's Hospital Long Beach (MCWH)
You may not qualify if:
- Active medical problems severe enough to not be eligible for receiving survivorship care with primary care provider at the time of recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- University of North Carolina, Chapel Hillcollaborator
- University of Colorado, Denvercollaborator
- Hackensack Meridian Healthcollaborator
- NYU Langone Healthcollaborator
- Seattle Children's Hospitalcollaborator
Study Sites (4)
MemorialCare Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806, United States
Children's Hospital Colorado
Denver, Colorado, 80045, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of North Carolina Children's Hospital
Chapel Hill, North Carolina, 27514, United States
Related Publications (1)
Ross WL, Santiago-Rivera Y, Tan MT, Roy MM, Bryant S, Appel BE, Casillas J, Demedis J, Smitherman AB, Horwitz LI, Hurtado-de-Mendoza A, Mendoza JA, Santacroce SJ, Kadan-Lottick NS. Design and methods of a multi-level intervention to improve adherence to childhood cancer survivorship care by partnering with primary care providers: The BRIDGES randomized controlled trial. Contemp Clin Trials. 2025 May;152:107859. doi: 10.1016/j.cct.2025.107859. Epub 2025 Feb 21.
PMID: 39987960DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Kadan-Lottick, MD, MSPH
Georgetown Lombardi Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
July 7, 2022
Study Start
January 1, 2023
Primary Completion
February 28, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After analysis and publication of data addressed in the the aims set forth in R01 CA261881
- Access Criteria
- Request to study investigators and compliance with all IRB and institutional data usage agreement requirements.
The proposed research will include data from 240 survivors of childhood cancer. The dataset will include (1) demographic data; (2) cancer diagnosis and treatment data; (3) adherence to survivorship care data; (4) knowledge, self-efficacy, and activation data; and (5) process outcomes (feasibility, fidelity, acceptability) data. In compliance with the National Institutes of Health Principles and Guidelines document, the investigators will readily provide all relevant protocols, publications, and the underlying primary data (to the extent possible as guided by the IRB) supporting publications to other academic investigators upon request. To maintain the privacy of the human subjects, data will de-identified. Should any intellectual property arise that requires a patent, the investigators will ensure that the technology (materials and data) remains widely available to the academic research community.