Follow-up in Early and Locally Advanced Breast Cancer Patients

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT03859453
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.

Detailed Description

The objective of this study is to assess follow-up patterns and identify patients with increased levels of physical and/or psychosocial problems after treatment in early breast cancer and locally advanced breast cancer.

830 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.

Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 139 Quality of Life questions, at one single time point.

Statistical analysis includes descriptive statistic for socio-demographic and clinical data, overall and per treatment, age and risk group. Patterns of follow-up will be identified and described overall, and per treatment, age, risk group and country.

Where available, normative data will be used to identify those QoL domains where there is a clinically relevant difference with the general population.

Multivariable model building will be used to build predictive models on the overall population to investigate determinants for the physical, sexual and emotional needs based on the identified PROM outcomes. Factor analysis will be undertaken to investigate the inter-correlations between physical, sexual and emotional needs in the overall population and in the relevant subgroups of interest.

The magnitude of the observed differences will be assessed by clinical important effect size rather than by statistical significance.

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Start: 2020-10-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 830

Inclusion Criteria

• Histologically proven Early Breast Cancer (EBC) and Locally Advanced Breast Cancer (LABC) patients who have completed their primary treatment (except endocrine therapy), between 12 months and 36 months after the diagnosis.
• Disease-free without any evidence of relapse
• Age ≥ 18 years.
• Ability to understand and fill out questionnaires.
• Written informed consent.

Exclusion Criteria

• Metastatic breast cancer (defined as secondary spread to other organs, such as bones, lung, liver, mediastinal lymph nodes) or DCIS.
• Other cancer diagnosis in the past 5 years except non-melanotic skin cancer or cervical intraepithelial neoplasia.
• Male breast cancer.
• Patients on maintenance therapy (other than endocrine therapy).
• Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
• Any psychological (including preexisting psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	18 months after first patient inclusion	It will be evaluated using self-administered Distress Thermometer

Trial Locations

Locations (28)

Hospital Universitario Reina Sofia; 🇪🇸 Córdoba, Spain

Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie; 🇩🇪 Leipzig, Germany

C.H.U. Sart-Tilman; 🇧🇪 Liège, Belgium

CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur; 🇧🇪 Namur, Belgium

IRCCS - Fondazione G. Pascale; 🇮🇹 Napoli, Italy

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis; 🇳🇱 Amsterdam, Netherlands

Assistance Publique Hopitaux Paris - Assistance Publique - Hopitaux de Paris - Hopital Tenon; 🇫🇷 Paris, De, France

Groupe Radiopole Artois - Centre de radiotherapie Marie Curie; 🇫🇷 Arras, France

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Firenze, Italy

Medical University Of Gdansk; 🇵🇱 Gdańsk, Poland

Universita Di Roma La Sapienza - Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea; 🇮🇹 Roma, Italy

Onze Lieve Vrouw Ziekenhuis; 🇧🇪 Aalst, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke; 🇩🇪 Wuppertal, Germany

The Great Poland Cancer Centre; 🇵🇱 Poznań, Poland

Tumor and Breast Center ZeTuP St. Gallen; 🇨🇭 St Gallen, Switzerland

Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology; 🇵🇱 Warsaw, Poland

Group Of Private Clinics Hirslanden - Hirslanden Klinik-Tumor Zentrum Aarau; 🇨🇭 Aarau, Switzerland

CHU Saint Pierre - CHU Saint-Pierre-Site Porte de Hal; 🇧🇪 Brussels, Belgium

Ospedale Generale Regionale; 🇮🇹 Bolzano, Italy

Ospedale San Gerardo; 🇮🇹 Monza, Italy

IRCCS - Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

King Hussein Cancer Center; 🇯🇴 Amman, Jordan

Clinica Universidad de Navarra; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Barts Health NHS Trust - St. Bartholomew'S Hospital; 🇬🇧 London, United Kingdom

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Leeds Teaching Hospitals NHS Trust - St. James's University Hospital; 🇬🇧 Leeds, United Kingdom