BRIDGES: A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

Sponsor
Georgetown University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05448560
Collaborator
University of North Carolina, Chapel Hill (Other), University of Colorado, Denver (Other), Hackensack Meridian Health (Other), NYU Langone Health (Other), Seattle Children's Hospital (Other)
240
2
47.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multi-level Intervention of shared model of survivorship care
  • Other: Comparison Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
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
Anticipated Study Start Date :
Sep 2, 2022
Anticipated Primary Completion Date :
Feb 28, 2026
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multi-level Intervention of shared model of survivorship care

Patient survivorship education via telehealth with the cancer center Ongoing patient-tailored education program by MyChart within the EHR patient portal Structured interactive phone communication between the research RN at the cancer center and community PCP clinic In-person visit with the PCP clinic for survivorship care.

Behavioral: 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, fatigue, physical activity, single kidney health, emotions/coping) that will then be sent over 1 year. 3) Structured interactive phone communication between the research RN at the cancer center and community PCP clinic- The discussion will explain the patient's cancer history, tumor recurrence monitoring schedule, individualized risk of late effects and surveillance schedule, psychosocial challenges, health behaviors, and coordination between the cancer center and PCP clinic. 4) In-person visit with the PCP clinic for survivorship care.

Active Comparator: "Gold standard" cancer center-based survivorship clinic

In-person visit at specialty survivorship clinic

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Patient completion of guideline-recommended surveillance tests for late effects of therapy [1-year post-randomization]

    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. Patient completion of guideline-recommended surveillance tests for late effects of therapy [2 years post-randomization]

    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

Secondary Outcome Measures

  1. Patient Knowledge: [1-year post-randomization]

    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.

  2. Patient Knowledge: [2-years post-randomization]

    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.

  3. Patient Healthcare Self-Efficacy [1-year post-randomization]

    Stanford Chronic Disease Self-Efficacy Scale (score range 1-10, higher score indicates greater self-efficacy) to be administered to patients and proxies

  4. Patient Healthcare Self-Efficacy [2-years post-randomization]

    Stanford Chronic Disease Self-Efficacy Scale (score range 1-10, higher score indicates greater self-efficacy) to be administered to patients and proxies

  5. Patient Activation [1-year post-randomization]

    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.

  6. Patient Activation [2-years post-randomization]

    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.

  7. PCP Knowledge and Self-Efficacy [1-year post-randomization]

    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.

  8. PCP Knowledge and Self-Efficacy [2-years post-randomization]

    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.

  9. Process Outcomes for Patients [1-year post-randomization]

    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.

  10. Process Outcomes for Primary Care Physicians [1-year post-randomization]

    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.

Other Outcome Measures

  1. Post-intervention qualitative interviews of participants and PCPs [1-year post-randomization]

    The investigators will conduct semi-structured, qualitative interviews with 1) 40 intervention participants and 2) 40 PCP clinics to generate feedback regarding the intervention (e.g. timing, duration, usability). Interviews will explore acceptability of the intervention and how to improve intervention efficacy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Georgetown University
  • University of North Carolina, Chapel Hill
  • University of Colorado, Denver
  • Hackensack Meridian Health
  • NYU Langone Health
  • Seattle Children's Hospital

Investigators

  • Principal Investigator: Nina Kadan-Lottick, MD, MSPH, Georgetown Lombardi Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Georgetown University
ClinicalTrials.gov Identifier:
NCT05448560
Other Study ID Numbers:
  • R01CA261881
First Posted:
Jul 7, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Georgetown University

Study Results

No Results Posted as of Aug 4, 2022