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

NCT07616258 | Recruiting DMC

• 1 other identifier: REC: 25-52
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

  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.

Secondary Outcomes (1)

• Breast Cancer Recurrence During Follow-Up

  Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group: * Hospital-based outpatient clinic appointments for two years * Annual mammogram * Patient satisfaction questionnaire, EQ5D5L

Other: De-Escalation of Management

Control

ACTIVE COMPARATOR

Control Group: * Hospital-based outpatient clinic appointments for five years * Annual mammogram * Patient satisfaction questionnaire, EQ5D5L

Other: Control

Interventions

De-Escalation of Management OTHER

Reduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same.

Intervention

Control OTHER

Standard of care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, D09V2N0, Ireland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI

CONTACT

+35318093000; adkhill@rcsi.com

Aisling Hegarty, PhD

CONTACT

018093000; Aislinghegarty@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre, prospective, non-blinded, randomised trial to be performed at one centre (Beaumont Hospital) over a 24-month period.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: June 1, 2026
• Study Start: October 2, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-02

Locations

IE (1)