240 Participants Needed

Multi-level Intervention for Childhood Cancer Survivorship Care Adherence

(BRIDGES Trial)

Recruiting at 3 trial locations
NK
Overseen ByNina Kadan-Lottick, MD, MSPH
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Georgetown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on education and communication for survivorship care, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment Multi-level Intervention for Childhood Cancer Survivorship Care Adherence?

Research shows that shared care models, which involve collaboration between different healthcare providers, can be effective in improving follow-up care for cancer survivors. This approach has been shown to maintain continuity of care and improve patient outcomes, suggesting it could be beneficial for childhood cancer survivors as well.12345

Is the Multi-level Intervention for Childhood Cancer Survivorship Care Adherence safe for humans?

The research highlights the importance of long-term follow-up care for childhood cancer survivors due to the risk of late-occurring health problems from previous treatments. While the studies emphasize the need for coordinated care and support, they do not specifically address the safety of the Multi-level Intervention itself.12678

How is the Multi-level Intervention for Childhood Cancer Survivorship Care Adherence treatment different from other treatments?

This treatment is unique because it uses a shared care model, which involves collaboration between pediatric oncology and adult primary care, often using telemedicine to improve continuity and adherence to care for childhood cancer survivors.134910

Research Team

NK

Nina Kadan-Lottick, MD, MSPH

Principal Investigator

Georgetown Lombardi Comprehensive Cancer Center

Eligibility Criteria

This trial is for childhood cancer survivors who are 2-4 years post-treatment, cancer-free with a life expectancy of over 2 years, and have not attended a specialty survivorship clinic. Participants must be English or Spanish speakers (including guardians if under 18) and treated at one of the four specified sites.

Inclusion Criteria

I was diagnosed with cancer before turning 21.
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)
I have undergone chemotherapy or radiation treatment.
See 4 more

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multi-level intervention including telehealth education, EHR patient portal education, structured phone communication, and in-person PCP clinic visit for survivorship care

1 year
Telehealth sessions, ongoing EHR interactions, phone communications, and in-person PCP visit

Follow-up

Participants are monitored for adherence to guideline-recommended surveillance tests and assessed for knowledge, self-efficacy, and process outcomes

1 year
1-year follow-up call and surveys

Post-intervention Evaluation

Qualitative interviews with participants and PCPs to gather feedback on the intervention

1 year post-randomization

Treatment Details

Interventions

  • Multi-level Intervention of shared model of survivorship care
Trial OverviewThe study tests an intervention to improve adherence to survivorship care. It includes telehealth education, tailored online programs, phone communication between the cancer center and primary care, and an in-person primary care visit.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Multi-level Intervention of shared model of survivorship careExperimental Treatment1 Intervention
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.
Group II: "Gold standard" cancer center-based survivorship clinicActive Control1 Intervention
In-person visit at specialty survivorship clinic

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials
355
Recruited
142,000+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

Hackensack Meridian Health

Collaborator

Trials
141
Recruited
42,900+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Findings from Research

A systematic review of 11 studies, including 8 randomized controlled trials, found that the shared care model for cancer survivors is as effective as usual care in terms of quality of life and clinical outcomes, while also being highly acceptable to patients and practitioners.
Patient satisfaction with shared care was reported to be higher than with usual care, suggesting that improved communication between primary and hospital care can enhance follow-up for cancer survivors.
The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review.Zhao, Y., Brettle, A., Qiu, L.[2022]
Primary care providers (PCPs) showed a strong interest in participating in shared care models for pediatric cancer survivors, despite having moderate to low familiarity with survivor care, indicating a need for better education and resources.
The development of Cancer SurvivorLink(TM), a web-based tool for securely sharing healthcare documents, along with targeted educational materials, has the potential to improve coordination of care and ensure that pediatric cancer survivors receive necessary follow-up for late effects of their treatment.
Primary care providers as partners in long-term follow-up of pediatric cancer survivors.Meacham, LR., Edwards, PJ., Cherven, BO., et al.[2021]
This pilot study involving 19 childhood cancer survivors and their primary care providers explored the use of telemedicine to improve the transition from pediatric oncology to adult primary care, with 13 successful telemedicine visits conducted.
Post-visit questionnaires indicated that the telemedicine approach increased knowledge and satisfaction among participants, although technical difficulties with the equipment were a notable challenge.
Shared Care of Childhood Cancer Survivors: A Telemedicine Feasibility Study.Costello, AG., Nugent, BD., Conover, N., et al.[2022]

References

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. [2022]
Primary care providers as partners in long-term follow-up of pediatric cancer survivors. [2021]
Shared Care of Childhood Cancer Survivors: A Telemedicine Feasibility Study. [2022]
Childhood Cancer Survivors' Adherence to Healthcare Recommendations Made Through a Distance-Delivered Survivorship Program. [2022]
Standardized versus personalized survivorship care plans for breast cancer survivors: A program evaluation. [2021]
Collaborative Research in Childhood Cancer Survivorship: The Current Landscape. [2022]
Cancer knowledge and health-consciousness in childhood cancer survivors following transition into adult care-results from the ACCS project. [2022]
Long-term care for people treated for cancer during childhood and adolescence. [2023]
Understanding predictors of continued long-term pediatric cancer care across the region: A report from the Consortium for New England Childhood Cancer Survivors. [2017]
The association of health status and cancer history of young adult survivors of childhood cancer with parental accompaniment to survivorship clinic visits. [2022]