A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best Practice, Patient Navigation, Patient Navigation, Referral.
- Who it may be relevant to
- Registry conditions: Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of a Navigation Program for Breast Cancer Survivors
Overview
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.
Detailed description
PRIMARY OBJECTIVES:
I. Increase the rate of referrals to survivorship support services among eligible breast cancer survivors by 50% within 12 months following implementation of a structured navigation program. (Aim 1) II. Reduce the rate of non-scheduled survivorship visits (defined as no appointment made within 30 days of referral) by 50% and increase the re-scheduling success rate among patients who initially cancel. (Aim 2)
SECONDARY OBJECTIVE:
I. Among patients identified as at-risk (minority race/ethnicity, rural residence, age ≥ 70), assess the uptake of coaching, and evaluate changes in self-efficacy scores before and after a 90-day navigation-based coaching intervention. (Aim 3)
OUTLINE:
Patients 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
- Other Best Practice
Attend survivorship consultation - Behavioral Patient Navigation
Receive patient navigator scheduling support - Behavioral Patient Navigation
Attend patient navigator coaching sessions - Other Referral
Receive survivorship referral - Other Survey Administration
Ancillary studies
Primary outcome measures
- Referral rates (Aims 1 & 2) [Time frame: From 12 months prior to intervention (baseline) up to 12 months during the program]
- Scheduling after referral (Aims 1 & 2) [Time frame: From 12 months prior to intervention (baseline) up to 12 months during the program]
- Clinic attendance (Aims 1 & 2) [Time frame: From 12 months prior to intervention (baseline) up to 12 months during the program]
Secondary outcome measures (4)
- Proportion of eligible patients who consent and initiate sessions (Acceptance) [Time frame: Up to 12 months]
- Change in patient-reported outcomes (PROMIS-10) [Time frame: Baseline to 90 days]
- Subgroup referral and uptake patterns [Time frame: Up to 12 months]
- Change in patient-reported outcomes (BSES) [Time frame: Baseline to 90 days]
Eligibility criteria
Inclusion criteria
- GENERAL INCLUSION (PRIMARY OBJECTIVE): Ages 18+
- GENERAL INCLUSION (PRIMARY OBJECTIVE): Diagnosed with non-metastatic breast cancer
- GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center
- COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who fall under any of the following:
- 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
Exclusion criteria
- Metastatic breast cancer at time of referral
- Prisoners or individuals unable to consent
- Non-English and non-Spanish speakers
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT07699991 · OSU-25094 · NCI-2026-04139 · STUDY20252451