Follow-up in Early and Locally Advanced Breast Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03859453

Enrollment

830

Registered

2019-03-01

Start date

2020-10-14

Completion date

2025-08-14

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Health-related quality of life	18 months after first patient inclusion	It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

Countries

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

Outcome results