About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Evidence of breast cancer recurrence or metastatic disease at the time of recruitment
Inability to provide informed consent
Inability to complete study questionnaires (e.g., due to language barriers or cognitive impairment)
Not resident in the Republic of Ireland or not intending to remain in follow-up within the Irish healthcare system
Trial population
Female patients, 18 years or older with a previous diagnosis of primary breast cancer who have completed two years of surveillance following curative treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
Deescalation of surveillance
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Health Related Quality of Life
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.
Secondary outcomes
Recurrence Rate and Time to Recurrence
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.
Change in Number of Patients Attending via Symptomatic Referral Pathway
The number of participants attending through the symptomatic referral pathway will be recorded and compared before and after implementation of the intervention.
Economic Burden of Surveillance Pathway
A cost analysis will be conducted comparing the standard surveillance pathway with the de-escalated surveillance pathway, including healthcare utilization costs.
Waiting Time for Newly Diagnosed Breast Cancer Patients
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.