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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRoyal College of Surgeons, Ireland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients who are under cancer surveillance for a primary breast cancer which was treated with curative intent

Aged 18 years or older at the time of 24-month surveillance

Demonstrate no clinical or radiological evidence of disease recurrence or metastases at the time of recruitment (e.g.: palpable mass, skin or nipple changes, new indeterminant mass on mammography, etc)

Fully fluent in English Language (Reading, Writing, and Speaking - has the ability to complete the EQ5D5L questionnaire in paper form and over the phone)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • De-Escalation of Management

    Other intervention

    Reduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same.

  • Control

    Other intervention

    Standard of care

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

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 at months 24, 36, 48 and 60 post randomisation.

Secondary outcomes

1

Breast Cancer Recurrence During Follow-Up

Number of participants with breast cancer recurrence identified during follow-up through annual mammography, clinical assessment, patient-reported symptoms, or medical record review.

Time frame
Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.

Other outcomes

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