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

30. dubna 2026 aktualizováno: Royal College of Surgeons, Ireland

Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer - A Prospective, Randomised Controlled 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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 investigators 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 investigators can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.

Right now, in Ireland, 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 is why investigators are looking at whether the number of hospital appointments can safely be reduced , 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.

Investigators will also ask all participants to complete a short questionnaire once a year. This will help investigators 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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

560

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Emma Forde, Medical Doctor & Scientist
  • Telefonní číslo: +353896126509
  • E-mail: eforde@rcsi.com

Studijní místa

  • Irsko
      • Dublin, Irsko, D09Y177
        • Nábor
        • Beaumont Hospital
        • Kontakt:
          • Emma E Forde, Licensed doctor
          • Telefonní číslo: +353 018092060
          • E-mail: eforde@rcsi.ie
        • Kontakt:
          • Professor ADK Hill, Professor and Chairman of Surgery
          • Telefonní číslo: +353 018092060
          • E-mail: ADKHILL@rcsi.ie
        • Vrchní vyšetřovatel:
          • Arnold DK Hill, Professor of Surgery

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

Female patients, 18 years or older with a previous diagnosis of primary breast cancer who have completed two years of surveillance following curative treatment

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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
Jiný: Deescalation of surveillance
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health Related Quality of Life
Časové okno: Participants will complete the questionnaire (paper-based or via telephone with the Advanced Nurse Practitioner) at 2, 3, 4, and 5 years.
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recurrence Rate and Time to Recurrence
Časové okno: Assessed at 2, 3, 4, and 5 years post enrollment, time to recurrence analyzed up to 5 years.
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.
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
Časové okno: Annually at 1, 2, 3, 4, and 5 years.
The number of participants attending through the symptomatic referral pathway will be recorded and compared before and after implementation of the intervention.
Annually at 1, 2, 3, 4, and 5 years.
Economic Burden of Surveillance Pathway
Časové okno: Costs will be assessed annually over 5 years and analyzed at 5 year follow-up.
A cost analysis will be conducted comparing the standard surveillance pathway with the de-escalated surveillance pathway, including healthcare utilization costs.
Costs will be assessed annually over 5 years and analyzed at 5 year follow-up.
Waiting Time for Newly Diagnosed Breast Cancer Patients
Časové okno: Assessed annually at 1, 2, 3, 4, and 5 years.
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.
Assessed annually at 1, 2, 3, 4, and 5 years.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Royal College of Surgeons, Ireland

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

11. prosince 2025

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

1. června 2028

Termíny zápisu do studia

První předloženo

5. prosince 2025

První předloženo, které splnilo kritéria kontroly kvality

30. dubna 2026

První zveřejněno (Aktuální)

7. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. dubna 2026

Naposledy ověřeno

1. prosince 2025

Více informací

Termíny související s touto studií

Klíčová slova

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