Follow-up in Early and Locally Advanced Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Follow-up in Early and Locally Advanced Breast Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03859453
• Other study ID #: EORTC-1617-QLG-BCG
• Status: Active, not recruiting
• Start date: October 14, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 830
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Jordan,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

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