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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
Beaumont RCSI Cancer Centre
RECRUITING
Beaumont
Contact Information
Primary
Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI
adkhill@rcsi.com
+35318093000
Backup
Aisling Hegarty, PhD
Aislinghegarty@rcsi.ie
018093000
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 560
Treatments
Experimental: Intervention
Intervention group:~* Hospital-based outpatient clinic appointments for two years~* Annual mammogram~* Patient satisfaction questionnaire, EQ5D5L
Active_comparator: Control
Control Group:~* Hospital-based outpatient clinic appointments for five years~* Annual mammogram~* Patient satisfaction questionnaire, EQ5D5L
Related Therapeutic Areas
Sponsors
Leads: Royal College of Surgeons, Ireland

This content was sourced from clinicaltrials.gov