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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Black and/or Hispanic

Disqualifiers

Metastatic breast cancer at time of referral

Prisoners or individuals unable to consent

Non-English and non-Spanish speakers

Trial design

Design model

Single group

Treatments tested in this trial

  • Best Practice

    Other intervention

    Attend survivorship consultation

  • Patient Navigation

    Behavioral

    Receive patient navigator scheduling support

  • Patient Navigation

    Behavioral

    Attend patient navigator coaching sessions

  • Referral

    Other intervention

    Receive survivorship referral

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: Supportive care (breast cancer survivor navigation program)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
From 12 months prior to intervention (baseline) up to 12 months during the program

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline to 90 days

Other outcomes

Sponsors and contacts

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