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Clinical Trial NCT05448560 (BRIDGES) for Childhood Cancer, Survivorship, Health Care Utilization, Health Knowledge, Attitudes, Practice, Adherence, Patient is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship (BRIDGES) 240 Telehealth

Active, not recruiting
Clinical Trial NCT05448560 (BRIDGES) is an interventional study for Childhood Cancer, Survivorship, Health Care Utilization, Health Knowledge, Attitudes, Practice, Adherence, Patient that is active, not recruiting. It started on January 1, 2023 with plans to enroll 240 participants. Led by Georgetown University, it is expected to complete by August 31, 2026. The latest data from ClinicalTrials.gov was last updated on August 20, 2025.
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...Show More
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 the...Show More
Official 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

Conditions
Childhood CancersurvivorshipHealth Care UtilizationHealth Knowledge, Attitudes, PracticeAdherence, Patient
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT05448560
Start Date (Actual)
2023-01-01
Last Update Posted
2025-08-20
Completion Date (Estimated)
2026-08-31
Enrollment (Estimated)
240
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
childhood cancer survivors
survivorship care
randomized controlled trial
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMulti-level Intervention of shared model of survivorship care
1. 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.
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...Show More
Active Comparator"Gold standard" cancer center-based survivorship clinic
In-person visit at specialty survivorship clinic
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
2 Years
Eligible Sexes
All
  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)

  • Active medical problems severe enough to not be eligible for receiving survivorship care with primary care provider at the time of recruitment
Georgetown University logoGeorgetown University
No contact data.
4 Study Locations in 1 Countries

California

MemorialCare Miller Children's & Women's Hospital Long Beach, Long Beach, California, 90806, United States

Colorado

Children's Hospital Colorado, Denver, Colorado, 80045, United States

New Jersey

Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States

North Carolina

University of North Carolina Children's Hospital, Chapel Hill, North Carolina, 27514, United States