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

2026年8月12日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

330

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • Ohio State University Comprehensive Cancer Center
        • 接触：
        • 首席研究员：
          • Bridget A. Oppong, MD, MPH

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：调查管理
辅助研究
其他：Best Practice
Attend survivorship consultation
其他名称：
  • 护理标准
  • 标准疗法
行为的：Patient Navigation
Receive patient navigator scheduling support
其他名称：
  • 患者导航程序
行为的：Patient Navigation
Attend patient navigator coaching sessions
其他名称：
  • 患者导航程序
其他：Referral
Receive survivorship referral
其他名称：
  • 推荐

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Referral rates (Aims 1 & 2)
大体时间：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)
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Proportion of eligible patients who consent and initiate sessions (Acceptance)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ohio State University Comprehensive Cancer Center

调查人员

  • 首席研究员：Bridget A Oppong, MD, MPH、Ohio State University Comprehensive Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • OSU-25094
  • NCI-2026-04139 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • STUDY20252451

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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