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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
330
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：The Ohio State University Comprehensive Cancer Center
- 電話番号：1-800-293-5066
- メール：OSUCCCClinicaltrials@osumc.edu
研究場所
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University Comprehensive Cancer Center
-
コンタクト：
- Bridget A. Oppong, MD, MPH
- 電話番号：614-293-6408
- メール：bridget.oppong@osumc.edu
-
主任研究者：
- Bridget A. Oppong, MD, MPH
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
補助研究
Attend survivorship consultation
他の名前：
Receive patient navigator scheduling support
他の名前：
Attend patient navigator coaching sessions
他の名前：
Receive survivorship referral
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Referral rates (Aims 1 & 2)
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of eligible patients who consent and initiate sessions (Acceptance)
時間枠：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.
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Up to 12 months
|
|
Change in patient-reported outcomes (PROMIS-10)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Bridget A Oppong, MD, MPH、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年7月7日
QC基準を満たした最初の提出物
2026年7月7日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月14日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OSU-25094
- NCI-2026-04139 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- STUDY20252451
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。