Follow-up in Early and Locally Advanced Breast Cancer Patients

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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 Type: Observational
• Enrollment (Actual): 830

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze Lieve Vrouw Ziekenhuis
  • Brussels, Belgium
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium
    • CHU Saint Pierre - CHU Saint-Pierre-Site Porte de Hal
  • Liège, Belgium
    • C.H.U. Sart-Tilman
  • Namur, Belgium
    • CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
• France
  • Arras, France
    • Groupe Radiopole Artois - Centre de radiotherapie Marie Curie
  • De
    • Paris, De, France
      • Assistance Publique Hopitaux Paris - Assistance Publique - Hopitaux de Paris - Hopital Tenon
• Germany
  • Leipzig, Germany
    • Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
  • Wuppertal, Germany
    • HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
• Italy
  • Bolzano, Italy
    • Ospedale Generale Regionale
  • Florence, Italy
    • Azienda Ospedaliero-Universitaria Careggi
  • Monza, Italy
    • Ospedale San Gerardo
  • Naples, Italy
    • IRCCS - Fondazione G. Pascale
  • Padova, Italy
    • IRCCS - Istituto Oncologico Veneto
  • Roma, Italy
    • Universita Di Roma La Sapienza - Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea
• Jordan
  • Amman, Jordan
    • King Hussein Cancer Center
• Netherlands
  • Amsterdam, Netherlands
    • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
• Poland
  • Gdansk, Poland
    • Medical University of Gdańsk
  • Poznan, Poland
    • The Great Poland Cancer Centre
  • Warsaw, Poland
    • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
• Spain
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Madrid, Spain
    • Clinica Universidad de Navarra
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Pamplona, Spain
    • Complejo Hospitalario de Navarra
• Switzerland
  • Aarau, Switzerland
    • Group Of Private Clinics Hirslanden - Hirslanden Klinik-Tumor Zentrum Aarau
  • Sankt Gallen, Switzerland, 9006
    • Tumor and Breast Center ZeTuP St. Gallen
• United Kingdom
  • Leeds, United Kingdom
    • Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
  • London, United Kingdom
    • Barts Health NHS Trust - St. Bartholomew'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	It will be evaluated using self-administered EORTC QLQ-C30 questionnaire	18 months after first patient inclusion
Health-related quality of life	It will be evaluated using self-administered EORTC-QLQ-BR-45 questionnaire	18 months after first patient inclusion
Health-related quality of life	It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire	18 months after first patient inclusion
Health-related quality of life	It will be evaluated using self-administered EORTC Sexual Health Questionnaire	18 months after first patient inclusion
Health-related quality of life	It will be evaluated using self-administered Distress Thermometer	18 months after first patient inclusion

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): August 14, 2025
• Study Completion (Actual): August 14, 2025

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: EORTC-1617-QLG-BCG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No