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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Childhood Cancer; Adherence, Patient; Health Knowledge, Attitudes, Practice; Health Care Utilization; Survivorship
• Intervention / Treatment: Behavioral: Multi-level Intervention of shared model of survivorship care; Other: Comparison Group

Detailed Description

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. Other barriers include travel distance, inadequate insurance, and out-of-pocket costs-these structural issues contribute to health disparities. 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. This 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 precipitated by the COVID-19 crisis. 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 electronic health record (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 includes 4 centers with high proportions of subgroups vulnerable to survivorship care disparities (i.e., rural, Black, Latinx, Spanish-speaking, socioeconomically disadvantaged). 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. The 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 survivorship care disparities. Transformative Impact: If the intervention demonstrates patient completion of recommended survivorship care comparable to cancer center survivorship clinic, the study has the enormous potential to deliver recommended lifelong care to a larger proportion of CCS and reduce survivorship care ies, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health maintenance.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Memorialcare Miller Children's & Women's Hospital Long Beach
  • Colorado
    • Denver, Colorado, United States, 80045
      • Children's Hospital Colorado
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with any cancer at age <21 years
2. Treated with chemotherapy and/or radiation
3. 2.0-4.0 years status post-completion of all cancer-related therapy
4. Cancer-free with a life expectancy of ≥2 years
5. English- or Spanish-speaking (also applies to parent/guardian if patient age <18 years)
6. No previous attendance at a specialty survivorship clinic
7. 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)

Exclusion Criteria:

• Active medical problems severe enough to not be eligible for receiving survivorship care with primary care provider at the time of recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-level Intervention of shared model of survivorship care; Patient survivorship education via telehealth with the cancer center; Ongoing patient-tailored education program by MyChart within the EHR patient portal; Structured interactive phone communication between the research RN at the cancer center and community PCP clinic; In-person visit with the PCP clinic for survivorship care.	Behavioral: Multi-level Intervention of shared model of survivorship care; 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.
Active Comparator: "Gold standard" cancer center-based survivorship clinic; In-person visit at specialty survivorship clinic	Other: Comparison Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Knowledge:	Patient Knowledge Survey developed by Kadan-Lottick et al. for the Childhood Cancer Survey Study which is a 9-item survey regarding treatment history, risk of late effects, need for survivorship care, and purpose of the survivorship care plan. Note that results will not be reported on a scale.	1-year post-randomization
Patient Knowledge:	Patient Knowledge Survey developed by Kadan-Lottick et al. for the Childhood Cancer Survey Study which is a 9-item survey regarding treatment history, risk of late effects, need for survivorship care, and purpose of the survivorship care plan. Note that results are not reported on a scale.	2-years post-randomization
Patient Healthcare Self-Efficacy	Stanford Chronic Disease Self-Efficacy Scale (score range 1-10, higher score indicates greater self-efficacy) to be administered to patients and proxies	1-year post-randomization
Patient Healthcare Self-Efficacy	Stanford Chronic Disease Self-Efficacy Scale (score range 1-10, higher score indicates greater self-efficacy) to be administered to patients and proxies	2-years post-randomization
Patient Activation	The 13-item Patient Activation Measure (PAM) will be administered to participants to evaluate the level of patient activation, i.e. patient self-reported knowledge, skill, and confidence for self-management of one's health or chronic condition. Scores range from 0-100 with higher scores reflecting greater patient activation.	1-year post-randomization
Patient Activation	The 13-item Patient Activation Measure (PAM) will be administered to participants to evaluate the level of patient activation, i.e. patient self-reported knowledge, skill, and confidence for self-management of one's health or chronic condition. Scores range from 0-100 with higher scores reflecting greater patient activation.	2-years post-randomization
PCP Knowledge and Self-Efficacy	Survey consisting of questions regarding the PCPs' familiarity with the surveillance guidelines and confidence in providing survivorship care. Note that results are not reported on a scale.	1-year post-randomization
PCP Knowledge and Self-Efficacy	Survey consisting of questions regarding the PCPs' familiarity with the surveillance guidelines and confidence in providing survivorship care. Note that results are not reported on a scale.	2-years post-randomization
Process Outcomes for Patients	Patients will complete a survey regarding process outcomes (i.e., feasibility, fidelity, acceptability) associated with the multi-level intervention. Note that results are not reported on a scale.	1-year post-randomization
Process Outcomes for Primary Care Physicians	Primary care physicians will complete a survey regarding process outcomes (i.e., feasibility, fidelity, acceptability) associated with the multi-level intervention. Note that results are not reported on a scale.	1-year post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-intervention qualitative interviews of participants and PCPs	The investigators will conduct semi-structured, qualitative interviews with 1) 40 intervention participants and 2) 40 PCP clinics to generate feedback regarding the intervention (e.g. timing, duration, usability). Interviews will explore acceptability of the intervention and how to improve intervention efficacy.	1-year post-randomization

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: University of Colorado, Denver; NYU Langone Health; Seattle Children's Hospital; University of North Carolina, Chapel Hill; Hackensack Meridian Health
• Investigators: Principal Investigator: Nina Kadan-Lottick, MD, MSPH, Georgetown Lombardi Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• NIH Reporter listing of this funded study by the National Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; childhood cancer survivors; survivorship care
• Other Study ID Numbers: R01CA261881 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After analysis and publication of data addressed in the the aims set forth in R01 CA261881
• IPD Sharing Access Criteria: Request to study investigators and compliance with all IRB and institutional data usage agreement requirements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No