Multi-level Intervention for Childhood Cancer Survivorship Care Adherence

(BRIDGES Trial)

Not currently recruiting at 3 trial locations

Overseen By Nina Kadan-Lottick, MD, MSPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Severe active medical problems

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help childhood cancer survivors adhere to recommended follow-up care after treatment. It compares a multi-level approach, called the Multi-level Intervention of shared model of survivorship care, with traditional visits at a specialized clinic. This approach includes education through telehealth, personalized programs via an online portal, structured phone calls, and in-person visits with a primary care doctor. The goal is to determine if this new method improves care adherence and knowledge for survivors. Individuals who had cancer before age 21, completed treatment 2-4 years ago, and have not yet visited a survivorship clinic may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative survivorship care strategies.

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 prior data suggests that this multi-level intervention is safe for childhood cancer survivors?

Research shows that the multi-level approach to caring for childhood cancer survivors is safe. This approach emphasizes education and communication between patients, their regular doctors, and cancer centers. A previous study found that components like online education and phone calls were well-received and did not cause significant side effects, indicating the approach is generally well-tolerated.

This trial does not test new drugs or treatments, so it is labeled as "Not Applicable" in terms of phase, which usually means fewer safety concerns. The goal is to improve adherence to care plans without introducing new risks. The focus is on enhancing care, ensuring participants can feel confident about the safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multi-level Intervention for childhood cancer survivorship care because it offers a holistic approach, unlike the traditional in-person visits at specialty survivorship clinics. This new protocol integrates telehealth education, personalized patient programs via MyChart, and structured communication between research nurses and primary care providers (PCPs), making it more accessible and tailored to individual needs. By including in-person visits at local PCP clinics, it bridges the gap between specialized care and community healthcare, potentially improving adherence and long-term health outcomes for childhood cancer survivors.

What evidence suggests that this trial's multi-level intervention could be effective for childhood cancer survivorship care adherence?

This trial will compare two approaches to childhood cancer survivorship care. Research has shown that a new approach, the Multi-level Intervention of shared model of survivorship care, can significantly help childhood cancer survivors adhere to their recommended care. More than 80% of these survivors face serious health problems after treatment, yet less than 20% receive the necessary follow-up care. This new method includes educating patients through online health services, creating personalized care plans, and improving communication between cancer centers and local doctors. Early results suggest this approach could help more survivors complete their care and receive the follow-up they need. By combining online and local doctor visits, this method shows promise in closing care gaps and supporting long-term health. ^{1 3 4 6 7}

Who Is on the Research Team?

Nina Kadan-Lottick, MD, MSPH

Principal Investigator

Georgetown Lombardi Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Multi-level Intervention of shared model of survivorship care

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.

How Is the Trial Designed?

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+

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39987960/

The BRIDGES randomized controlled trial Design and methods of a multi-level intervention to improve adherence to childhood cancer survivorship care by partnering with primary care ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000539

Design and methods of a multi-level intervention to ... The goal of the BRIDGES Study is to evaluate the effects of a multi-level, remote intervention on adherence to guideline-recommended surveillance among CCS.

3. researchgate.net researchgate.net/publication/389230362_Design_and_methods_of_a_multi-level_intervention_to_improve_adherence_to_childhood_cancer_survivorship_care_by_partnering_with_primary_care_providers_The_BRIDGES_randomized_controlled_trial

The BRIDGES randomized controlled trial | Request PDF Design and methods of a multi-level intervention to improve adherence to childhood cancer survivorship care by partnering with primary care ...

4. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11166590

Project Details - NIH RePORTER More than 80% of childhood cancer survivors (CCS) develop serious or life-threatening late effects. Yet <20% of CCS receive recommended survivorship care, ...

5. link.springer.com link.springer.com/article/10.1007/s11764-024-01610-6

Childhood cancer models of survivorship care: a scoping ... This study aimed to systematically map elements of care and respective outcomes described in the literature for different models of post-treatment care for ...

6. reporter.nih.gov reporter.nih.gov/project-details/10914873

BRidging Information Divides and Gaps to Ensure Survivorship In a shared care model, we propose to investigate an innovative multi-level intervention consisting of: 1) patient survivorship education via telehealth with ...

7. cancercontrol.cancer.gov cancercontrol.cancer.gov/ocs/special-focus-areas/models-of-survivorship-care

Models of Survivorship Care There are many models of survivorship care, including (but not limited to) oncology-led, primary care-led, shared care, and multidisciplinary survivorship ...