Multi-level Intervention for Childhood Cancer Survivorship Care Adherence

(BRIDGES Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Nina Kadan-Lottick, MD, MSPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgetown University

Disqualifiers: Severe active medical problems

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 3 4 9 10}

Research Team

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.

Exclusion Criteria

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

Trial 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 (Behavioral Intervention)

Trial Overview The 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

Group I: Multi-level Intervention of shared model of survivorship care Experimental Treatment 1 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 clinic Active Control 1 Intervention

In-person visit at specialty survivorship clinic

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Dr. Ivica Labuda

Georgetown University

Chief Executive Officer since 2022

PhD in Biochemistry and Molecular & Cellular Biology from Slovak Academy of Sciences, University of Graz, and Rutgers University

Dr. Richard Ascione

Georgetown University

Chief Medical Officer since 2023

MD from Georgetown University Medical School

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Dr. Gregory J. Rokosz

Hackensack Meridian Health

Chief Medical Officer since 2023

DO from New York College of Osteopathic Medicine, JD from Seton Hall University School of Law

Robert C. Garrett

Hackensack Meridian Health

Chief Executive Officer since 2016

Bachelor's degree in Health Administration from Washington University in St. Louis

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Dr. Jeff Sperring

Seattle Children's Hospital

Chief Executive Officer since 2015

MD from Indiana University School of Medicine

Dr. Jeff Ojemann

Seattle Children's Hospital

Chief Medical Officer since 2022

MD from Washington University in St. Louis

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Care of Childhood Cancer Survivors: A Telemedicine Feasibility Study. Costello, AG., Nugent, BD., Conover, N., et al.[2022]

A study involving 25 long-term childhood cancer survivors revealed that many struggle to recall and adhere to healthcare recommendations, with only 1.3 out of an average of 6.6 recommendations followed by the six-month follow-up.

Survivors with a history of a second cancer and those more worried about late effects were more likely to adhere to recommendations, highlighting the importance of addressing concerns and improving communication to enhance adherence and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood Cancer Survivors' Adherence to Healthcare Recommendations Made Through a Distance-Delivered Survivorship Program. Alchin, JE., Signorelli, C., McLoone, JK., et al.[2022]

The Wellness Beyond Cancer Program evaluated the effectiveness of standardized survivorship care plans (SCPs) for 87 breast cancer survivors, finding that these plans provided similar outcomes in perceived knowledge and patient activation compared to personalized SCPs.

Standardized SCPs are cost-efficient and could help reduce resource constraints in cancer care, suggesting they may be a viable option for implementation in cancer centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized versus personalized survivorship care plans for breast cancer survivors: A program evaluation. Rutkowski, N., MacDonald-Liska, C., Baines, KA., et al.[2021]

Survivors of childhood cancer face significant long-term health issues and an increased risk of premature death, highlighting the importance of ongoing health monitoring after treatment.

Collaborative research efforts, such as those by the Children's Oncology Group, are crucial for understanding treatment-related complications and developing guidelines for lifelong follow-up and targeted interventions for high-risk survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Research in Childhood Cancer Survivorship: The Current Landscape. Bhatia, S., Armenian, SH., Armstrong, GT., et al.[2022]

Childhood cancer survivors (CCSs) transitioning to adult care generally possess good knowledge about their cancer and high self-management skills, as shown in a study of 57 CCSs.

The study identified key worries among CCSs, such as concerns about late effects of treatment and future fertility, along with expectations for their follow-up care, which can guide improvements in long-term follow-up practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer knowledge and health-consciousness in childhood cancer survivors following transition into adult care-results from the ACCS project. Otth, M., Denzler, S., Diesch-Furlanetto, T., et al.[2022]

Survivors of childhood and adolescent cancer face a high risk of late-occurring health issues, including serious conditions affecting the heart, endocrine system, and mental health, due to the long-term effects of their treatments.

Effective care coordination and communication during the transition from pediatric to adult healthcare can empower these survivors and improve their health outcomes, highlighting the need for resources like late-effects surveillance guidelines and support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term care for people treated for cancer during childhood and adolescence. Tonorezos, ES., Cohn, RJ., Glaser, AW., et al.[2023]

In a study of 317 survivors of acute lymphoblastic leukemia (ALL), 90% were alive and 88% remained in active follow-up care 5 years after diagnosis, indicating a strong adherence to oncology care among childhood cancer survivors.

Factors such as insurance status at diagnosis, age, and whether patients were enrolled in a therapeutic study significantly influenced follow-up attendance, with those having private insurance and being part of a study more likely to continue care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding predictors of continued long-term pediatric cancer care across the region: A report from the Consortium for New England Childhood Cancer Survivors. Welch, JJG., Kenney, LB., Hirway, P., et al.[2017]

In a study of 168 adult survivors of childhood cancer, 45.8% were accompanied by a parent during their first visit to a survivorship clinic, but this accompaniment did not correlate with the survivors' health complexity or emotional distress.

Parental accompaniment was also not linked to adherence to recommended surveillance tests or follow-up appointments, suggesting that having a parent present does not influence the survivors' engagement with their healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of health status and cancer history of young adult survivors of childhood cancer with parental accompaniment to survivorship clinic visits. Janardan, SK., Balsamo, LM., Ross, WL., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Primary care providers as partners in long-term follow-up of pediatric cancer survivors. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Shared Care of Childhood Cancer Survivors: A Telemedicine Feasibility Study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Childhood Cancer Survivors' Adherence to Healthcare Recommendations Made Through a Distance-Delivered Survivorship Program. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Standardized versus personalized survivorship care plans for breast cancer survivors: A program evaluation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Collaborative Research in Childhood Cancer Survivorship: The Current Landscape. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer knowledge and health-consciousness in childhood cancer survivors following transition into adult care-results from the ACCS project. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Long-term care for people treated for cancer during childhood and adolescence. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Understanding predictors of continued long-term pediatric cancer care across the region: A report from the Consortium for New England Childhood Cancer Survivors. [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

The association of health status and cancer history of young adult survivors of childhood cancer with parental accompaniment to survivorship clinic visits. [2022]