Clinical trial · Observational
Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Breast Cancer
Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer - A Prospective, Randomised Controlled Trial
NCT07572370CI-TRIAL-00110779De-EscalationrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deescalation of surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control
- description
- 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
- label
- Intervention
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (10)
- BACKGROUNDWattchow DA, Weller DP, Esterman A, Pilotto LS, McGorm K, Hammett Z, Platell C, Silagy C. General practice vs surgical-based follow-up for patients with colon cancer: randomised controlled trial. Br J Cancer. 2006 Apr 24;94(8):1116-21. doi: 10.1038/sj.bjc.6603052. PMID 16622437
- BACKGROUNDKimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174. PMID 20429948
- BACKGROUNDBrown L, Payne S, Royle G. Patient initiated follow up of breast cancer. Psychooncology. 2002 Jul-Aug;11(4):346-55. doi: 10.1002/pon.576. PMID 12203747
- BACKGROUNDMontgomery DA, Krupa K, Cooke TG. Follow-up in breast cancer: does routine clinical examination improve outcome? A systematic review of the literature. Br J Cancer. 2007 Dec 17;97(12):1632-41. doi: 10.1038/sj.bjc.6604065. Epub 2007 Nov 13. PMID 18000508
- BACKGROUNDHoran J, Reid C, Boland MR, Daly GR, Keelan S, Lloyd AJ, Downey E, Walmsley A, Staunton M, Power C, Butt A, Duke D, Hill ADK. Assessing Mode of Recurrence in Breast Cancer to Identify an Optimised Follow-Up Pathway: 10-Year Institutional Review. Ann Surg Oncol. 2023 Oct;30(10):6117-6124. doi: 10.1245/s10434-023-13885-7. Epub 2023 Jul 21. PMID 37479843
- BACKGROUNDGrunfeld E, Fitzpatrick R, Mant D, Yudkin P, Adewuyi-Dalton R, Stewart J, Cole D, Vessey M. Comparison of breast cancer patient satisfaction with follow-up in primary care versus specialist care: results from a randomized controlled trial. Br J Gen Pract. 1999 Sep;49(446):705-10. PMID 10756611
- BACKGROUNDDretzke J, Chaudri T, Balaji R, Mehanna H, Nankivell P, Moore DJ; PETNECK2 Research Team. A systematic review of the effectiveness of patient-initiated follow-up after cancer. Cancer Med. 2023 Sep;12(18):19057-19071. doi: 10.1002/cam4.6462. Epub 2023 Aug 21.