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

NCT07572370 | Recruiting DMC

• 1 other identifier: 25/52
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Surveillance; Follow up; Deescalation of breast cancer surveillance

Outcome Measures

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.

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

Secondary Outcomes (4)

• Recurrence Rate and Time to Recurrence

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

• Change in Number of Patients Attending via Symptomatic Referral Pathway

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

• Economic Burden of Surveillance Pathway

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

• Waiting Time for Newly Diagnosed Breast Cancer Patients

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

Study Arms (2)

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

Other: Deescalation of surveillance

Interventions

Deescalation of surveillance OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females previously diagnosed and treated for breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont Hospital

Dublin, D09Y177, Ireland

RECRUITING

Related Publications (10)

• General practice vs surgical-based follow-up for patients with colon cancer: randomised controlled trial. Wattchow D A., Weller DP, Esterman A. et al. British Journal of Cancer (2006) 94, 1116 - 1121

  BACKGROUND

• Patient satisfaction with nurse-led telephone fiollow-up after curative treatment for breast cancer. Kimman M. L. , Bloebaum M. MF, Dirksen C. D, et al. BMC Cancer 2010, 10:174

  BACKGROUND

• Brown 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 BACKGROUND

• Follow-up in breast cancer: does routine clinical examination improve outcome? A systemic review of the literature. Montgomery DA, Krupa K, Cooke TG. British Journal of Cancer (2007) 97, 1632 - 1641

  BACKGROUND

• Assessing Mode of Recurrence in Breast Cancer to Identify an Optimised Follow-Up Pathway: 10-Year Institutional Review. Horan J., Reid C., Boland M.R. et al. Ann Surg Oncol 30, 6117-6124 (2023) https://doi.org/10.1245/s10434-023-13885-7

  BACKGROUND

• Comparison of breast cancer patient satisfaction with follow-up in primary care versus specialist care: results from a randomized controlled trial. Grunfeld E., Fitzpatrick R., Mant D. et al. British Journal of General Practice, 1999, 49, 705-710

  BACKGROUND

• 4) A systemic review of the effectiveness of patient-initiated follow-up after cancer. Dretzke J., Chaudri T., Balaji R. et al. Cancer Medicine. 2023;12:19057-19071

  BACKGROUND

• AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2022. Ditsch N., W.cke A., Untch M., et al. Breast Care 2022;17:403-420

  BACKGROUND

• American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. Runowicz C. D., Leach C. R., PhD, Henry N. L., et al. CA Cancer J Clin 2016;66:43-73.VC 2015 American Cancer Society

  BACKGROUND

• National Cancer Control Programme (NCCP), Draft HSE National Clinical Guideline, Post-treatment follow-up of patients with breast cancer

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Emma Forde, Medical Doctor & Scientist

CONTACT

+353896126509; eforde@rcsi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: May 7, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)