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Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer (De-Escalation)

2026년 5월 29일 업데이트: Royal College of Surgeons, Ireland

Breast cancer is the most common cancer in women around the world. That means a lot of women are affected by it every year, and it's important that we always look for ways to improve their care, not just during treatment, but afterwards too. After treatment for early-stage breast cancer, patients usually come back to the hospital for regular check-ups for up to five years. These visits are based on old guidelines, and even though breast cancer treatment has improved a lot over the years, the follow-up schedule has stayed the same. This study is being done to see if we can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.

Right now, patients are asked to attend follow-up appointments at 6, 12, 18, 24, 36, 48 and 60 months (that's every 6 to 12 months for five years). These clinic visits often involve long waits and can cause stress or anxiety. At the same time, patients are also invited for a mammogram once a year. Recent research shows that most recurrences of breast cancer are found by patients themselves or during their annual mammograms, not necessarily at these clinic visits. That's why we're looking at whether we can safely reduce the number of hospital appointments, without affecting patient safety.

In this study, some patients will continue with the usual five-year clinic schedule. Others will only attend hospital clinics for the first two years (at 6, 12, 18 and 24 months), and after that, they will no longer need to come in for the extra follow-up visits, but they will still have their annual mammograms as normal.

Within this study all participants will complete a short questionnaire once a year. This will help us understand how the different follow-up plans affect quality of life, and how patients feel about their care. This research study is taking place to find out if fewer hospital check-ups, combined with continued mammogram screening, is just as safe and possibly better for patients' wellbeing.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This study began in 2025 at the Breast Centre in Beaumont RCSI Cancer Centre. We expect that around 600 people will take part. If you agree to join the study, you will be placed into one of two groups:

  • One group will continue with the usual follow-up plan after breast cancer treatment. This includes regular hospital visits for up to five years.
  • The other group will follow a new plan, where hospital visits will stop after two years, but yearly mammograms will continue as normal.
  • Participants will continue to have access to the breast care team by the usual contact points such as your breast care nurse. All patients following treatment of breast cancer in Beaumont hospital are provided with a direct phone number to contact the breast care nurse should they have any concern.

Participants won't need to take any new medicines or treatments. Each year, we'll ask you to complete a short questionnaire (either in person or over the phone) to tell us how participants are feeling and how the follow-up process is working for them.

This will help the researchers understand whether the new follow-up plan is just as safe and possibly more convenient for patients.

Participants will be placed into one of two groups, this will be chosen at random (like flipping a coin). Both groups will be followed for a total of five years after their breast cancer treatment.

Group 1 - Current Follow-Up Plan (Usual Care):

  • Continue with the current schedule of hospital clinic visits at: 6, 12, 18, 24, 36, 48 and 60 months after your treatment
  • Be invited for your annual mammogram as normal
  • Be asked to fill in a short questionnaire at your clinic visits at 24, 36, 48, and 60 months. This will help us understand how you're feeling and your experience with follow-up care
  • All your appointments will take place in person at the Breast Centre in Beaumont Hospital.

Group 2 - New Follow-Up Plan (Study Group):

  • Attend clinic visits at: 6, 12, 18, and 24 months after treatment
  • Be discharged from hospital clinics after 2 years
  • Continue to have your annual mammogram as normal
  • Fill in the same questionnaire at 24 months in person, and then by telephone at 36, 48 and 60 months
  • If you are in this group and ever feel you would prefer to return to hospital clinic visits, you will be supported to do so.

No extra hospital visits, medical tests, or blood samples are required for this study. The questionnaire may ask about your health, daily activities, and how you feel about the follow-up care you are receiving. Some people may find questions about quality of life or cancer follow-up a little emotional or upsetting, but you can skip any question you don't want to answer. Researchers may look at medical records to check information about diagnosis, treatment, and follow-up care. This will be done confidentially, and only by members of the research team who are trained to handle personal health information safely.

연구 유형

중재적

등록 (추정된)

560

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI
  • 전화번호: +35318093000
  • 이메일: adkhill@rcsi.com

연구 장소

  • 아일랜드
    • Dublin
      • Beaumont, Dublin, 아일랜드, D09V2N0
        • 모병
        • Beaumont RCSI Cancer Centre
        • 연락하다:

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:

  • Participants will be identified according to the eligibility criteria and will be approached and invited to participate in this study while attending the outpatient department at the breast centre in Beaumont Hospital. To be eligible to participate in this study, an individual must meet all of the following eligibility criteria:
  • Female patients who are under cancer surveillance for a primary breast cancer which was treated with curative intent
  • Aged 18 years or older at the time of 24-month surveillance
  • Demonstrate no clinical or radiological evidence of disease recurrence or metastases at the time of recruitment (e.g.: palpable mass, skin or nipple changes, new indeterminant mass on mammography, etc)
  • Fully fluent in English Language (Reading, Writing, and Speaking - has the ability to complete the EQ5D5L questionnaire in paper form and over the phone)
  • Has a formal address in the Republic of Ireland and has the intention of undergoing further surveillance in this country

Exclusion Criteria:

All individuals meeting any of the exclusion criteria at baseline or during screening will be excluded from study participation as per the following criteria: - An individual who fails to meet any of the aforementioned inclusion criteria will be excluded from participation in this study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention

Intervention group:

  • Hospital-based outpatient clinic appointments for two years
  • Annual mammogram
  • Patient satisfaction questionnaire, EQ5D5L
다른: De-Escalation of Management
Reduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same.
활성 비교기: Control

Control Group:

  • Hospital-based outpatient clinic appointments for five years
  • Annual mammogram
  • Patient satisfaction questionnaire, EQ5D5L
다른: 제어
치료의 표준

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
기간: Measured at months 24, 36, 48 and 60 post randomisation.
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on five response levels. Responses will be converted to an EQ-5D-5L index score using validated scoring methods. Higher index scores indicate better health-related quality of life.
Measured at months 24, 36, 48 and 60 post randomisation.

2차 결과 측정

결과 측정
측정값 설명
기간
Breast Cancer Recurrence During Follow-Up
기간: Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.
Number of participants with breast cancer recurrence identified during follow-up through annual mammography, clinical assessment, patient-reported symptoms, or medical record review.
Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Royal College of Surgeons, Ireland

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 (실제)

2025년 10월 2일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2028년 12월 30일

연구 등록 날짜

최초 제출

2026년 2월 16일

QC 기준을 충족하는 최초 제출

2026년 5월 29일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 29일

마지막으로 확인됨

2026년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • REC: 25-52

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

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. .

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스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다