Beaumont Hospital
Dublin, D09Y177, Ireland
Location status: Recruiting
Location contact
Arnold DK Hill, Professor of Surgery
PRINCIPAL_INVESTIGATOR
Emma E Forde, Licensed doctor
CONTACT
Professor ADK Hill, Professor and Chairman of Surgery
CONTACT
NCT Number: NCT07572370
Patients who were diagnosed with breast cancer and have finished their treatment will be given the opportunity to be part of this study. These patients will have been attending surveillance at the Breast Centre in Beaumont Hospital, Ireland for 2 years prior. These patients, who are doing well after breast cancer treatment, will be given the opportunity to enrol in this study, potentially being discharged from in person surveillance after 2 years, while still attending for their annual mammogram. Investigators intend to find out if a simpler follow-up plan could work just as safely, while also improving the patients quality of life.
Interested in participating?
Request Info18 year and older
Female
Observational
Dublin, D09Y177, Ireland
Location status: Recruiting
Arnold DK Hill, Professor of Surgery
PRINCIPAL_INVESTIGATOR
Emma E Forde, Licensed doctor
CONTACT
Professor ADK Hill, Professor and Chairman of Surgery
CONTACT
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 investigators 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 investigators can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.
Right now, in Ireland, 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 is why investigators are looking at whether the number of hospital appointments can safely be reduced , 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.
Investigators will also ask all participants to complete a short questionnaire once a year. This will help investigators 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will attend hospital-based in-person specialist surveillance clinics according to the current practice post initial diagnosis for the first two years following curative resection and treatment of their primary breast cancer and then discharged from the service (i.e.: patients will receive six monthly specialist follow-up appointments for the first 24 months). Mammographic surveillance will be as described for the control group. Every patient will undergo an annual mammogram until the age of seventy years (or if aged 70 at the time of diagnosis, they will have an annual mammogram for five years in total). As per standard practice all results from these annual mammogram studies will be copied to the patients' general practitioner. If any abnormalities are detected on mammogram the patient will be contacted. All participants will complete the health-related quality of life questionnaire, EQ5D5L at the 24 (2 year), 36 (3 year), 48 (4 year) and 50 month (5 year) timepoint.
Time frame: Participants will complete the questionnaire (paper-based or via telephone with the Advanced Nurse Practitioner) at 2, 3, 4, and 5 years.
Health related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses are converted into a single index value, typically ranging from less than 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life. The instrument also includes a visual analogue scale (EQ VAS) ranging from 0 to 100, with higher scores indicating better perceived health.
Time frame: Assessed at 2, 3, 4, and 5 years post enrollment, time to recurrence analyzed up to 5 years.
Recurrence rate will be defined as the proportion of participants diagnosed with disease recurrence during follow-up. Time to recurrence will be defined as the time from study enrollment to the date of first confirmed recurrence.
Time frame: Annually at 1, 2, 3, 4, and 5 years.
The number of participants attending through the symptomatic referral pathway will be recorded and compared before and after implementation of the intervention.
Time frame: Costs will be assessed annually over 5 years and analyzed at 5 year follow-up.
A cost analysis will be conducted comparing the standard surveillance pathway with the de-escalated surveillance pathway, including healthcare utilization costs.
Time frame: Assessed annually at 1, 2, 3, 4, and 5 years.
Waiting time will be defined as the time from referral to first outpatient appointment for patients with newly diagnosed breast cancer. Annual changes in waiting times will be evaluated.
Contact information is provided by the study sponsor or research team.
Royal College of Surgeons, Ireland
Other
Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer - A Prospective, Randomised Controlled Trial
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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