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

12 août 2026 mis à jour par: Bridget Oppong, Ohio State University Comprehensive Cancer Center

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

330

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Ohio
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Bridget A. Oppong, MD, MPH

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Administration de l'enquête
Etudes annexes
Autre: Best Practice
Attend survivorship consultation
Autres noms:
  • norme de soins
  • thérapie standard
Comportemental: Patient Navigation
Receive patient navigator scheduling support
Autres noms:
  • Programme de navigateur des patients
Comportemental: Patient Navigation
Attend patient navigator coaching sessions
Autres noms:
  • Programme de navigateur des patients
Autre: Referral
Receive survivorship referral
Autres noms:
  • Référé

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Referral rates (Aims 1 & 2)
Délai: 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.
From 12 months prior to intervention (baseline) up to 12 months during the program
Scheduling after referral (Aims 1 & 2)
Délai: 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.
From 12 months prior to intervention (baseline) up to 12 months during the program
Clinic attendance (Aims 1 & 2)
Délai: 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.
From 12 months prior to intervention (baseline) up to 12 months during the program

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of eligible patients who consent and initiate sessions (Acceptance)
Délai: 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.
Up to 12 months
Change in patient-reported outcomes (PROMIS-10)
Délai: 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.
Baseline to 90 days
Subgroup referral and uptake patterns
Délai: 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.
Up to 12 months
Change in patient-reported outcomes (BSES)
Délai: 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.
Baseline to 90 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ohio State University Comprehensive Cancer Center

Les enquêteurs

  • Chercheur principal: Bridget A Oppong, MD, MPH, Ohio State University Comprehensive Cancer Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

7 juillet 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

13 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OSU-25094
  • NCI-2026-04139 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • STUDY20252451

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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