Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
NCT Number: NCT07616258
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
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:
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):
Group 2 - New Follow-Up Plan (Study Group):
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Reduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same.
Standard of care
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Aisling Hegarty, PhD
CONTACT
Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI
CONTACT
Royal College of Surgeons, Ireland
Other
Acronym: De-Escalation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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