Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer - A Prospective, Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Female participants aged 18 years or older
• Prior diagnosis of primary breast cancer treated with curative intent
• Currently under cancer surveillance and at the 24-month follow-up timepoint
• No clinical or radiological evidence of disease recurrence or metastasis at the time of recruitment (e.g., no palpable mass, skin or nipple changes, or suspicious findings on imaging)
• Able to read, write, and speak English sufficiently to complete the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire (paper-based or via telephone)
• Resident in the Republic of Ireland with a fixed address and intention to continue follow-up within the Irish healthcare system
Locations
Other Locations
Ireland
Beaumont Hospital
RECRUITING
Dublin
Contact Information
Primary
Emma Forde, Medical Doctor & Scientist
eforde@rcsi.com
+353896126509
Time Frame
Start Date:2025-12-11
Estimated Completion Date:2028-06-01
Participants
Target number of participants:560
Treatments
Control
Patients will attend routine hospital-based in-person surveillance according to current practice post initial diagnosis (i.e.: patients will receive six monthly in-person specialist surveillance appointments for the first 24 months following curative resection and treatment of their primary breast cancer. Thereafter, these patients will attend annually until five years surveillance is reached and they will then be discharged from the service). 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). All participants in this group will complete the health-related quality of life questionnaire, EQ5D5L at the 24 (2 year), 36 (3 year), 48 (4 year) and 60 month (5 year) timepoint
Intervention
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