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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRoyal College of Surgeons, Ireland

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Deescalation of surveillance

    Other 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.

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: Control0 interventions
Group B: Intervention1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Participants will complete the questionnaire (paper-based or via telephone with the Advanced Nurse Practitioner) at 2, 3, 4, and 5 years.

Secondary outcomes

1

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.

Time frame
Assessed at 2, 3, 4, and 5 years post enrollment, time to recurrence analyzed up to 5 years.
2

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.

Time frame
Annually at 1, 2, 3, 4, and 5 years.
3

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.

Time frame
Costs will be assessed annually over 5 years and analyzed at 5 year follow-up.
4

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.

Time frame
Assessed annually at 1, 2, 3, 4, and 5 years.

Other outcomes

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