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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 ag

Первичные конечные точки

• Health Related Quality of Life [Срок оценки: Participants will complete the questionnaire (paper-based or via telephone with the Advanced Nurse Practitioner) at 2, 3, 4, and 5 years.]

Вторичные конечные точки (4)

• Recurrence Rate and Time to Recurrence [Срок оценки: 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 [Срок оценки: Annually at 1, 2, 3, 4, and 5 years.]
• Economic Burden of Surveillance Pathway [Срок оценки: Costs will be assessed annually over 5 years and analyzed at 5 year follow-up.]
• Waiting Time for Newly Diagnosed Breast Cancer Patients [Срок оценки: Assessed annually at 1, 2, 3, 4, and 5 years.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Ирландия · 1 центр

• Beaumont Hospital — Dublin

Публикации

• Wattchow 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
• Kimman 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
• 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
• Montgomery 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
• Horan 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
• Grunfeld 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
• Dretzke 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. PMID 37602830
• Ditsch N, Wocke A, Untch M, Jackisch C, Albert US, Banys-Paluchowski M, Bauerfeind I, Blohmer JU, Budach W, Dall P, Fallenberg EM, Fasching PA, Fehm TN, Friedrich M, Gerber B, Gluz O, Harbeck N, Heil J, Huober J, Kreipe HH, Krug D, Kuhn T, Kummel S, Kolberg-Liedtke C, Loibl S, Luftner D, Lux MP, Maass N, Mundhenke C, Nitz U, Park-Simon TW, Reimer T, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Schut PMID 36156915

Идентификаторы

NCT: NCT07572370 · 25/52

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗