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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate and Time to Recurrence | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Females previously diagnosed and treated for breast cancer
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Female patients, 18 years or older with a previous diagnosis of primary breast cancer who have completed two years of surveillance following curative treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Forde, Medical Doctor & Scientist | Contact | +353896126509 | eforde@rcsi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Recruiting | Dublin | D09Y177 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16622437 | Background | 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. | |
| 20429948 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Change in Number of Patients Attending via Symptomatic Referral Pathway | 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 | 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 | 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. |
| 12203747 | 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. |
| 18000508 | Background | 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. |
| 37479843 | Background | 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. |
| 10756611 | Background | 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. |
| 37602830 | Background | 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. |
| 36156915 | Background | 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, Schutz F, Sinn HP, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Witzel I, Muller V, Janni W, Thill M. AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2022. Breast Care (Basel). 2022 Aug;17(4):403-420. doi: 10.1159/000524879. Epub 2022 May 5. |
| 26641959 | Background | Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 Jan-Feb;66(1):43-73. doi: 10.3322/caac.21319. Epub 2015 Dec 7. |
| Background | National Cancer Control Programme (NCCP), Draft HSE National Clinical Guideline, Post-treatment follow-up of patients with breast cancer |
| D017437 |
| Skin and Connective Tissue Diseases |