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Anatomic Stage 0 Breast Cancer AJCC v8NCT07699991

A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors

A study testing Best Practice, Patient Navigation and Referral in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Best Practice, Patient Navigation and Referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteUnited States
Study dates
9 Dec 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Metastatic breast cancer at time of referral
  • Prisoners or individuals unable to consent
  • Non-English and non-Spanish speakers

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

1-800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Bridget A. Oppong, MD, MPH, 614-293-6408, bridget.oppong@osumc.edu

    Bridget A. Oppong, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: Implementation of a Navigation Program for Breast Cancer Survivors

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Best Practice, Patient Navigation, Referral, Survey Administration
Medical subject headings
Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Attend survivorship consultation

  • Patient NavigationBehavioural

    Also called Patient Navigator Program

    Receive patient navigator scheduling support

  • Patient NavigationBehavioural

    Also called Patient Navigator Program

    Attend patient navigator coaching sessions

  • ReferralOther

    Also called Referred

    Receive survivorship referral

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07699991
Study groupRoleWhat they receive
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.
Receives: Other: Best Practice; Behavioral: Patient Navigation; Other: Referral; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From 12 months prior to intervention (baseline) up to 12 months during the program

  2. 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.

    Measured: From 12 months prior to intervention (baseline) up to 12 months during the program

  3. 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.

    Measured: From 12 months prior to intervention (baseline) up to 12 months during the program

Secondary outcomes (4)

  1. Proportion of eligible patients who consent and initiate sessions (Acceptance)

    Among patients meeting eligibility criteria (Black, Hispanic, age ≥ 70, rural ZIP code), acceptance of coaching will be measured as the proportion of eligible patients who consent and initiate sessions. Will be analyzed using descriptive statistics and regression models to evaluate predictors of acceptance.

    Measured: Up to 12 months

  2. Change in patient-reported outcomes (PROMIS-10)

    Patient Reported Outcomes Measurement Information System-10 [PROMIS-10] will be collected at baseline and at 90-day follow-up. The PROMIS-10 includes 10 questions that evaluate the participants health related quality of life. Changes in self-efficacy and quality of life will be evaluated within individuals. Changes in PROMIS-10 scores will be assessed using paired t-tests or Wilcoxon signed-rank tests, as appropriate.

    Measured: Baseline to 90 days

  3. Subgroup referral and uptake patterns

    Analyses will assess whether referral rates, scheduling, coaching uptake, and patient-reported outcomes differ by demographic or clinical subgroups (e.g., age, race, rurality, insurance, education level). Subgroup analyses will employ stratified analyses and regression modeling to identify differences across patient characteristics.

    Measured: Up to 12 months

  4. Change in patient-reported outcomes (BSES)

    Breast Cancer Survivor Self-Efficacy Scale [BSES] will be collected at baseline and at 90-day follow-up. Changes in self-efficacy and quality of life will be evaluated within individuals. Changes in BSES scores will be assessed using paired t-tests or Wilcoxon signed-rank tests, as appropriate.

    Measured: Baseline to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start9 Dec 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699991
Sponsor's protocol ID
OSU-25094
Other IDs
NCI-2026-04139, STUDY20252451
Status last verified
Oct 2026
First submitted
7 Jul 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Patient Navigation and Referral in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (1-800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Referral rates (Aims 1 & 2) (time frame: From 12 months prior to intervention (baseline) up to 12 months during the program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07699991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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