Clinical trial NCT03859453: Follow-up in Early and Locally Advanced Breast Cancer Patients
Official title: Follow-up in Early and Locally Advanced Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2019-03-01
Enrollment: 830
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: 18 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 18 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 18 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 18 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 18 months after first patient inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Brussels
country: Belgium
facility: CHU Saint Pierre - CHU Saint-Pierre-Site Porte de Hal
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liège
country: Belgium
facility: C.H.U. Sart-Tilman
city: Namur
country: Belgium
facility: CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
city: Paris
country: France
facility: Assistance Publique Hopitaux Paris - Assistance Publique - Hopitaux de Paris - Hopital Tenon
state: De
city: Arras
country: France
facility: Groupe Radiopole Artois - Centre de radiotherapie Marie Curie
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
city: Wuppertal
country: Germany
facility: HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
city: Bolzano
country: Italy
facility: Ospedale Generale Regionale
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Napoli
country: Italy
facility: IRCCS - Fondazione G. Pascale
city: Padova
country: Italy
facility: IRCCS - Istituto Oncologico Veneto
city: Roma
country: Italy
facility: Universita Di Roma La Sapienza - Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea
city: Amman
country: Jordan
facility: King Hussein Cancer Center
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
city: Gdańsk
country: Poland
facility: Medical University Of Gdansk
city: Poznań
country: Poland
facility: The Great Poland Cancer Centre
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Aarau
country: Switzerland
facility: Group Of Private Clinics Hirslanden - Hirslanden Klinik-Tumor Zentrum Aarau
city: St Gallen
country: Switzerland
facility: Tumor and Breast Center ZeTuP St. Gallen
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St. Bartholomew'S Hospital
Study officials:
References: