A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors
2026년 8월 12일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
330
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: The Ohio State University Comprehensive Cancer Center
- 전화번호: 1-800-293-5066
- 이메일: OSUCCCClinicaltrials@osumc.edu
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- 모병
- Ohio State University Comprehensive Cancer Center
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연락하다:
- Bridget A. Oppong, MD, MPH
- 전화번호: 614-293-6408
- 이메일: bridget.oppong@osumc.edu
-
수석 연구원:
- Bridget A. Oppong, MD, MPH
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
보조 연구
Attend survivorship consultation
다른 이름들:
Receive patient navigator scheduling support
다른 이름들:
Attend patient navigator coaching sessions
다른 이름들:
Receive survivorship referral
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Referral rates (Aims 1 & 2)
기간: From 12 months prior to intervention (baseline) up to 12 months during the program
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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.
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From 12 months prior to intervention (baseline) up to 12 months during the program
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Scheduling after referral (Aims 1 & 2)
기간: From 12 months prior to intervention (baseline) up to 12 months during the program
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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.
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From 12 months prior to intervention (baseline) up to 12 months during the program
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Clinic attendance (Aims 1 & 2)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of eligible patients who consent and initiate sessions (Acceptance)
기간: 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
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Change in patient-reported outcomes (PROMIS-10)
기간: Baseline to 90 days
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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.
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Baseline to 90 days
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Subgroup referral and uptake patterns
기간: Up to 12 months
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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.
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Up to 12 months
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Change in patient-reported outcomes (BSES)
기간: Baseline to 90 days
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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.
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Baseline to 90 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bridget A Oppong, MD, MPH, Ohio State University Comprehensive Cancer Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 12일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OSU-25094
- NCI-2026-04139 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- STUDY20252451
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .