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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-04139 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY20252451 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (breast cancer survivor navigation program) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Attend survivorship consultation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 1-800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bridget A Oppong, MD, MPH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Patient Navigation | Behavioral | Receive patient navigator scheduling support |
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| Patient Navigation | Behavioral | Attend patient navigator coaching sessions |
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| Referral | Other | Receive survivorship referral |
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| Survey Administration | Other | Ancillary studies |
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| 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. | Baseline to 90 days |
| 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. | Up to 12 months |
| 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. | Baseline to 90 days |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D062526 | Patient Navigation |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
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