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
Conditions
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.
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
OTHERBest Practice
Attend survivorship consultation
BEHAVIORALPatient Navigation
Receive patient navigator scheduling support
OTHERReferral
Receive survivorship referral
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Referral rates (Aims 1 & 2) | From 12 months prior to intervention (baseline) up to 12 months during the program | 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. |
| Scheduling after referral (Aims 1 & 2) | From 12 months prior to intervention (baseline) up to 12 months during the program | 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. |
| Clinic attendance (Aims 1 & 2) | From 12 months prior to intervention (baseline) up to 12 months during the program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible patients who consent and initiate sessions (Acceptance) | Up to 12 months | 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. |
| Change in patient-reported outcomes (PROMIS-10) | Baseline to 90 days | 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. |
| Subgroup referral and uptake patterns | Up to 12 months | 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. |
| Change in patient-reported outcomes (BSES) | Baseline to 90 days | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORBridget A Oppong, MD, MPH
Ohio State University Comprehensive Cancer Center
Outcome results
None listed