Recruiting

Navigation Program

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07699991

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

Localized Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Patient Navigation

Patient Navigation

Referral

Survey Administration

Study Details

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.

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

Localized Breast Carcinoma

Study ID

NCT07699991

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

330 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (breast cancer survivor navigation program)

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

Best Practice

Attend survivorship consultation

Patient Navigation

Receive patient navigator scheduling support

Patient Navigation

Attend patient navigator coaching sessions

Referral

Receive survivorship referral

Survey Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

1-800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Bridget A. Oppong, MD, MPH

614-293-6408bridget.oppong@osumc.edu

Principal Investigator:

Bridget A. Oppong, MD, MPH

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-14.