A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors
Implementation of a Navigation Program for Breast Cancer Survivors
3 other identifiers
interventional
330
1 country
1
Brief Summary
This clinical trial studies whether a navigation program improves survivorship support service participation among survivors of breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Advances in treatment have caused the number of breast cancer survivors to grow. As this number increases, there are reported unmet supportive care needs in this population, including psychological distress and limitations in physical functioning. To address these needs, many cancer centers offer programming on a variety of topics including psychological services, exercise counseling, and nutrition counseling. Research has shown that while interest in these survivorship programs is high, participation remains low, especially among minority women. Navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The navigation program in this trial is specifically focused on helping breast cancer survivors schedule and attend survivorship consultation appointments as well as providing additional support to underserved/vulnerable patients. A navigation program may be effective in improving survivorship support service participation among non-metastatic breast cancer survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
July 13, 2026
July 1, 2026
1.3 years
July 7, 2026
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Referral rates (Aims 1 & 2)
Will be tracked for all patients referred to the Survivorship Clinic. Rates will be calculated by dividing the number of events by the total number of eligible patients in each period. Will be compared between baseline and intervention periods using chi-square tests or logistic regression models.
From 12 months prior to intervention (baseline) up to 12 months during the program
Scheduling after referral (Aims 1 & 2)
Will be tracked for all patients referred to the Survivorship Clinic. Rates will be calculated by dividing the number of events by the total number of eligible patients in each period. Will be compared between baseline and intervention periods using chi-square tests or logistic regression models.
From 12 months prior to intervention (baseline) up to 12 months during the program
Clinic attendance (Aims 1 & 2)
Will be tracked for all patients referred to the Survivorship Clinic. Rates will be calculated by dividing the number of events by the total number of eligible patients in each period. Will be compared between baseline and intervention periods using chi-square tests or logistic regression models.
From 12 months prior to intervention (baseline) up to 12 months during the program
Secondary Outcomes (4)
Proportion of eligible patients who consent and initiate sessions (Acceptance)
Up to 12 months
Change in patient-reported outcomes (PROMIS-10)
Baseline to 90 days
Subgroup referral and uptake patterns
Up to 12 months
Change in patient-reported outcomes (BSES)
Baseline to 90 days
Study Arms (1)
Supportive care (breast cancer survivor navigation program)
EXPERIMENTALPatients receive a referral to survivorship at James Cancer Supportive Care Clinic and attend a survivorship consultation visit consisting of standard survivorship care and referrals at baseline. Patients who do not schedule or cancel the survivorship consultation visit receive patient navigator support to help with scheduling. Following survivorship consult, underserved/vulnerable patients may attend five patient navigator coaching sessions over 90 days.
Interventions
Attend survivorship consultation
Receive patient navigator scheduling support
Receive survivorship referral
Ancillary studies
Eligibility Criteria
You may qualify if:
- Black and/or Hispanic
- Ages ≥ 70
- Reside in a ZIP code classified as rural by United States Department of Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes
You may not qualify if:
- Metastatic breast cancer at time of referral
- Prisoners or individuals unable to consent
- Non-English and non-Spanish speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bridget A Oppong, MD, MPH
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 7, 2026
First Posted
July 13, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 13, 2026
Record last verified: 2026-07