An observational study in Breast Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 28 sites in 10 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Observational
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 830 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.
Exclusion Criteria:
Health-related quality of life
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Time frame: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC-QLQ-BR-45 questionnaire
Time frame: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
Time frame: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
Time frame: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered Distress Thermometer
Time frame: 18 months after first patient inclusion
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC