Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study (BRIDGES-YAS!)

Randomized Controlled Trial of a Remote, Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study

Although 95% of young adult childhood cancer survivors (YA CCS) will develop chronic health conditions, suboptimal transition to adult-oriented care leads to <20% receiving recommended lifelong survivorship care. YA CCS survivorship follow-up care at the pediatric cancer treatment center is limited by organization- and patient-level barriers. This study overcomes these barriers by transitioning survivors to community adult primary care providers (PCPs) after orienting PCPs to survivors' individual survivorship care needs and educating YA CCS regarding health self-management/advocacy. This study includes a remote transition approach for YA survivorship care that leverages community PCPs, telehealth, and nurse navigators (NNs). BRIDGES-YAS! will investigate a novel, remote, multi-level intervention to transition YA CCS to community adult PCPs for a survivorship visit versus usual cancer treatment center (CTC) based follow-up care (plus educational handout about transition). The 1-year intervention includes: 1) tailored telehealth CCS education and resource navigation with self-management and self-advocacy skills training by a CTC NN, 2) brief, structured, interactive phone handoff by CTC NN to the community PCP conveying the CCS's individualized survivorship care needs, 3) secure electronic storage on CCS' smartphone (or other device) of Survivorship Care Plan and established health education materials, and 4) ongoing NN support and communication between CCS, CTC, and PCP. If successful, this intervention strategy could readily be deployed in cancer treatment centers to improve adult survivor access to quality, community-based survivorship care.

Study Overview

• Status: Not yet recruiting
• Conditions: Survivors of Childhood Cancer; Health Care Transition; Patient Navigation; Survivorship Care
• Intervention / Treatment: Behavioral: Structured Transition to PCP; Behavioral: Comparison Arm

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

Contacts and Locations

• Study Contact: Name: Nina S Kadan-Lottick, MD, MSPH; Phone Number: 202-444-7599; Email: nk873@georgetown.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: Monica M Gramatges, MD, PhD; Phone Number: (205) 638-2120; Email: mmgramatges@uabmc.edu
  • Colorado
    • Denver, Colorado, United States, 80045
      • Children's Hospital Colorado
      • Contact: Jenna Demedis, MD; Phone Number: 720-777-6740; Email: Jenna.Demedis@childrenscolorado.org
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
      • Contact: Rozalyn L Rodwin, MD, MHS; Email: rozalyn.rodwin@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of cancer at age <19 years
• Current age 18-26.99 years (typical transition age for young adult childhood cancer survivors)
• History of chemotherapy and/or radiation
• ≥2 and <10 years post-completion of all cancer-related therapy (including oral chemotherapy)
• Cancer-free with a life expectancy of ≥2 years
• Followed at one of the 3 study sites (Yale University, University of Alabama at Birmingham, Children's Hospital Colorado)

Exclusion Criteria:

• Patients at the Children's Hospital Colorado study site who choose to participate in their cancer treatment center's structured, in-person transition program.

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: Structured Transition to primary care provider (PCP); Multi-level intervention including telehealth patient education by a nurse navigator (NN) from the patient's cancer treatment center (CTC), handoff from the CTC NN to the patient's primary care provider (PCP) conveying the patient's individualized survivorship care needs, secure electronic storage of established health care materials on the patient's smartphone, and ongoing CTC NN support and facilitation of communication between the patient, CTC, and PCP.	Behavioral: Structured Transition to PCP; Transition of young adult childhood cancer survivors (YA CCS) to adult primary care providers (PCPs) in the community for a survivorship care visit. The one-year intervention includes: I) Tailored, telehealth-supported CCS education regarding their Survivorship Care Plan that includes self-management and self-advocacy skills training and resource navigation by a cancer treatment center (CTC) nurse navigator (NN), II) Brief, interactive phone handoff by the CTC NN to the community PCP conveying the CCS' individualized survivorship care needs, III) Secure electronic storage of key health care materials (e.g., Survivorship Care Plan, health self-management tools) on the patient's smartphone, and IV) Ongoing CTC NN support and facilitation of communication between the patient, CTC, and PCP.
Active Comparator: Usual Care; In-person visit at CTC survivorship clinic.	Behavioral: Comparison Arm; Usual follow-up care as per their CTC in real world settings, including elements of recommended care such as the individualized Survivorship Care Plan and educational handout on transition to adult care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Survivorship Care Composite Score	A single Quality of Survivorship Care Composite Score will be calculated from completion rates in 5 prioritized categories from the 2024 United States National Standards for Cancer Survivorship Care set forth by the National Cancer Institute: 1) physical effects, 2) chronic conditions, 3) new cancers (including genetic risk), 4) psychosocial effects (including financial hardship), and 5) health behaviors. Each category's completion rate will be converted to a z-score using the comparison arm's mean and standard deviation; the composite score is the average of the 5 z-scores, with higher scores indicating higher quality of care. Assessments include physical exam, history, tests, and/or referrals individualized to treatment exposures per the Children's Oncology Group Long-Term Follow-Up Guidelines Version 6.0, as delineated in the Survivorship Care Plan. Research staff not involved in patient care will abstract data and determine completion of recommended assessments.	1 year post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Self-Management and Self-Advocacy Skills, Measured by the Transition Readiness Assessment Questionnaire Version 5.0	Self-management and self-advocacy skills will be assessed with the validated 20-item Transition Readiness Assessment Questionnaire Version 5.0. The questionnaire includes 5 subscales: managing medications, appointment keeping, and tracking health issues (self-management), and talking with providers and managing daily activities (self-advocacy). Items are rated on a 5-point Likert scale, and the total score is the mean of all item responses (range 1 to 5). Higher scores indicate greater self-management and self-advocacy, respectively.	Baseline and 1 year post-randomization
Trust in Provider, Measured by the Wake Forest Physician Trust Scale	Trust in the provider delivering survivorship care will be assessed with the validated 10-item Wake Forest Physician Trust Scale. Items are rated on a 5-point Likert scale and summed for a total score (range 10 to 50). Higher values indicate greater trust.	Baseline and 1 year post-randomization
Feasibility of the Intervention, Measured by the Feasibility of Intervention Measure	Among participants randomized to the intervention arm, intervention feasibility will be assessed with the validated 4-item Feasibility of Intervention Measure. Items are rated on a 5-point Likert scale, and the total score is the mean of item responses (range 1 to 5). Higher scores indicate greater feasibility.	1 year post-randomization
Acceptability of the Intervention, Measured by the Acceptability of Intervention Measure	Among participants randomized to the intervention arm, intervention acceptability will be measured using the validated 4-item Acceptability of Intervention Measure. Items are rated on a 5-point Likert scale, and the total score is the mean of item responses (range 1 to 5). Higher scores indicate greater acceptability.	1 year post-randomization
Fidelity of Intervention	Fidelity will be measured as the percentage of the 4 intervention components delivered per protocol for each intervention-arm participant: telehealth education, the structured phone handoff to the primary care provider (PCP), smartphone storage of the Survivorship Care Plan, and ongoing nurse navigator support. Completion will come from nurse navigator and research staff tracking logs.	1 year post-randomization
Cost of Survivorship Care	Cost of survivorship care during the study period will be estimated for each participant and compared between randomization arms. Costs will be combined into a single total per participant from three components: 1) Nurse navigator time, from nurse navigator time logs, 2) Survivorship care visit costs at the cancer treatment centers and primary care provider clinics, based on billing codes, reimbursement rates, time per patient, and additional services or staffing per visit, and 3) Participant-reported out-of-pocket survivorship care expenses, measured with the Costs for Patients Questionnaire. Higher values will indicate greater cost.	1 year post-randomization
Perceived Financial Toxicity, Measured by the COmprehensive Score for financial Toxicity	Perceived financial toxicity will be assessed with the validated COmprehensive Score for financial Toxicity measure. Items are rated on a 5-point Likert scale and summed for a total score ranging from 0 to 44. Lower scores indicate greater financial toxicity.	Baseline and 1 year post-randomization

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Cancer Institute (NCI); Yale University; University of Alabama at Birmingham; Children's Hospital Colorado; NYU Langone Health

Publications and helpful links

Helpful Links

• <p>NIH Reporter listing of this funded study by the National Cancer Institute</p>

Study record dates

Study Major Dates

• Study Start (Estimated): March 9, 2027
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: October 23, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; childhood cancer survivors; young adults; survivorship care
• Other Study ID Numbers: The BRIDGES-YAS! Study; R01CA303073 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

This study will include data from 240 young adult survivors of childhood cancer. Expected data: human medical record data and human self-reported data from surveys (including validated instruments). Data will be formatted in tabular comma-separared values (.csv) files. De-identified data will be deposited into the Harvard Dataverse repository.

IPD Sharing Time Frame

After analysis and publication of data addressed in the aims set forth in R01CA303073.

IPD Sharing Access Criteria

De-identified data will be deposited into the Harvard Dataverse repository.

• 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