Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer (De-Escalation)
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 we 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 we can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.
Right now, 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's why we're looking at whether we can safely reduce the number of hospital appointments, 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.
Within this study all participants will complete a short questionnaire once a year. This will help us 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study began in 2025 at the Breast Centre in Beaumont RCSI Cancer Centre. We expect that around 600 people will take part. If you agree to join the study, you will be placed into one of two groups:
- One group will continue with the usual follow-up plan after breast cancer treatment. This includes regular hospital visits for up to five years.
- The other group will follow a new plan, where hospital visits will stop after two years, but yearly mammograms will continue as normal.
- Participants will continue to have access to the breast care team by the usual contact points such as your breast care nurse. All patients following treatment of breast cancer in Beaumont hospital are provided with a direct phone number to contact the breast care nurse should they have any concern.
Participants won't need to take any new medicines or treatments. Each year, we'll ask you to complete a short questionnaire (either in person or over the phone) to tell us how participants are feeling and how the follow-up process is working for them.
This will help the researchers understand whether the new follow-up plan is just as safe and possibly more convenient for patients.
Participants will be placed into one of two groups, this will be chosen at random (like flipping a coin). Both groups will be followed for a total of five years after their breast cancer treatment.
Group 1 - Current Follow-Up Plan (Usual Care):
- Continue with the current schedule of hospital clinic visits at: 6, 12, 18, 24, 36, 48 and 60 months after your treatment
- Be invited for your annual mammogram as normal
- Be asked to fill in a short questionnaire at your clinic visits at 24, 36, 48, and 60 months. This will help us understand how you're feeling and your experience with follow-up care
- All your appointments will take place in person at the Breast Centre in Beaumont Hospital.
Group 2 - New Follow-Up Plan (Study Group):
- Attend clinic visits at: 6, 12, 18, and 24 months after treatment
- Be discharged from hospital clinics after 2 years
- Continue to have your annual mammogram as normal
- Fill in the same questionnaire at 24 months in person, and then by telephone at 36, 48 and 60 months
- If you are in this group and ever feel you would prefer to return to hospital clinic visits, you will be supported to do so.
No extra hospital visits, medical tests, or blood samples are required for this study. The questionnaire may ask about your health, daily activities, and how you feel about the follow-up care you are receiving. Some people may find questions about quality of life or cancer follow-up a little emotional or upsetting, but you can skip any question you don't want to answer. Researchers may look at medical records to check information about diagnosis, treatment, and follow-up care. This will be done confidentially, and only by members of the research team who are trained to handle personal health information safely.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aisling Hegarty, PhD
- Numéro de téléphone: 018093000
- E-mail: Aislinghegarty@rcsi.ie
Sauvegarde des contacts de l'étude
- Nom: Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI
- Numéro de téléphone: +35318093000
- E-mail: adkhill@rcsi.com
Lieux d'étude
-
-
Dublin
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Beaumont, Dublin, Irlande, D09V2N0
- Recrutement
- Beaumont RCSI Cancer Centre
-
Contact:
- Aisling Hegarty, PhD
- Numéro de téléphone: 018093000
- E-mail: Aislinghegarty@rcsi.ie
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Participants will be identified according to the eligibility criteria and will be approached and invited to participate in this study while attending the outpatient department at the breast centre in Beaumont Hospital. To be eligible to participate in this study, an individual must meet all of the following eligibility criteria:
- Female patients who are under cancer surveillance for a primary breast cancer which was treated with curative intent
- Aged 18 years or older at the time of 24-month surveillance
- Demonstrate no clinical or radiological evidence of disease recurrence or metastases at the time of recruitment (e.g.: palpable mass, skin or nipple changes, new indeterminant mass on mammography, etc)
- Fully fluent in English Language (Reading, Writing, and Speaking - has the ability to complete the EQ5D5L questionnaire in paper form and over the phone)
- Has a formal address in the Republic of Ireland and has the intention of undergoing further surveillance in this country
Exclusion Criteria:
All individuals meeting any of the exclusion criteria at baseline or during screening will be excluded from study participation as per the following criteria: - An individual who fails to meet any of the aforementioned inclusion criteria will be excluded from participation in this study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Intervention group:
|
Reduction in hospital based appointments to 2 years only and discharge to primary care for follow up post same.
|
|
Comparateur actif: Control
Control Group:
|
Norme de soins
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Délai: Measured at months 24, 36, 48 and 60 post randomisation.
|
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The EQ-5D-5L evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on five response levels.
Responses will be converted to an EQ-5D-5L index score using validated scoring methods.
Higher index scores indicate better health-related quality of life.
|
Measured at months 24, 36, 48 and 60 post randomisation.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Breast Cancer Recurrence During Follow-Up
Délai: Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.
|
Number of participants with breast cancer recurrence identified during follow-up through annual mammography, clinical assessment, patient-reported symptoms, or medical record review.
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Measured with annual mammogram and clinical outcomes at months 12, 24, 36, 48 and 60 post randomisation.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC: 25-52
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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