Clinical trial NCT05448560: A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Survivorship
Health Care Utilization
Health Knowledge, Attitudes, Practice
Adherence, Patient
Keywords: childhood cancer survivors
survivorship care
randomized controlled trial
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Colorado, Denver
name: Hackensack Meridian Health
name: NYU Langone Health
name: Seattle Children's Hospital
First posted: 2022-07-07
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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-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.

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 their past cancer and lack knowledge and self-efficacy for survivorship care. Other barriers include travel distance, inadequate insurance, and out-of-pocket costs-these structural issues contribute to health disparities. Partnering with community primary care provider (PCP) clinics in a shared model of care is a promising strategy to overcome these barriers, but PCPs lack knowledge, self-efficacy, and interactive communication with the cancer center and are confused about the division of care responsibilities. This intervention is scalable and distance-based, is informed directly by patient and PCP barriers and preferences from previous studies, and is boosted by a nationwide explosion in telehealth services precipitated by the COVID-19 crisis. The proposed randomized controlled trial will enroll 240 CCS 2.0-4.0 years post-chemotherapy/radiation to investigate an innovative multi-level intervention (i.e., interpersonal and organizational levels) consisting of 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record (EHR)'s patient portal, 3) a structured interactive phone communication between the cancer center and the PCP clinic (with 1-year follow-up call), and 4) an in-person visit with the PCP clinic for survivorship care. The comparison group will be randomized to an in-person visit with their cancer center survivorship clinic. This study includes 4 centers with high proportions of subgroups vulnerable to survivorship care disparities (i.e., rural, Black, Latinx, Spanish-speaking, socioeconomically disadvantaged). Both groups will be asked to begin recommended surveillance for late effects within 1-year post-randomization, separate from tumor recurrence monitoring by the primary oncologist. The Specific Aims are to Aim 1- Demonstrate patient completion of guideline-recommended surveillance tests in intervention participants is not inferior, i.e. within 10%, to that in the comparison group; Aim 2- Achieve greater 1) patient knowledge, self-efficacy, and activation and 2) PCP knowledge and self-efficacy with survivorship care among intervention participants and their PCPs compared to the comparison group; and Aim 3- Ascertain process outcomes for the 1) patient and 2) PCP clinic. Outcomes will also be assessed among subgroups with survivorship care disparities. Transformative Impact: If the intervention demonstrates patient completion of recommended survivorship care comparable to cancer center survivorship clinic, the study has the enormous potential to deliver recommended lifelong care to a larger proportion of CCS and reduce survivorship care ies, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health maintenance.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Patient completion of guideline-recommended surveillance tests for late effects of therapy
timeFrame: 1-year post-randomization
measure: Patient completion of guideline-recommended surveillance tests for late effects of therapy
timeFrame: 2 years post-randomization
Secondary outcomes:
measure: Patient Knowledge:
timeFrame: 1-year post-randomization
measure: Patient Knowledge:
timeFrame: 2-years post-randomization
measure: Patient Healthcare Self-Efficacy
timeFrame: 1-year post-randomization
measure: Patient Healthcare Self-Efficacy
timeFrame: 2-years post-randomization
measure: Patient Activation
timeFrame: 1-year post-randomization
measure: Patient Activation
timeFrame: 2-years post-randomization
measure: PCP Knowledge and Self-Efficacy
timeFrame: 1-year post-randomization
measure: PCP Knowledge and Self-Efficacy
timeFrame: 2-years post-randomization
measure: Process Outcomes for Patients
timeFrame: 1-year post-randomization
measure: Process Outcomes for Primary Care Physicians
timeFrame: 1-year post-randomization
Other outcomes:
measure: Post-intervention qualitative interviews of participants and PCPs
timeFrame: 1-year post-randomization
Locations:
city: Long Beach
country: United States
facility: MemorialCare Miller Children's & Women's Hospital Long Beach
state: California
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina Children's Hospital
state: North Carolina
Study officials:
affiliation: Georgetown Lombardi Comprehensive Cancer Center
name: Nina Kadan-Lottick, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: