Follow-up in Early and Locally Advanced Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03859453|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : December 23, 2020
|Condition or disease|
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|
|Estimated Enrollment :||830 participants|
|Official Title:||Follow-up in Early and Locally Advanced Breast Cancer Patients|
|Actual Study Start Date :||October 14, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
- Health-related quality of life [ Time Frame: 18 months after first patient inclusion ]It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
- Health-related quality of life [ Time Frame: 18 months after first patient inclusion ]It will be evaluated using self-administered EORTC-QLQ-BR-45 questionnaire
- Health-related quality of life [ Time Frame: 18 months after first patient inclusion ]It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
- Health-related quality of life [ Time Frame: 18 months after first patient inclusion ]It will be evaluated using self-administered EORTC Sexual Health Questionnaire
- Health-related quality of life [ Time Frame: 18 months after first patient inclusion ]It will be evaluated using self-administered Distress Thermometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859453
|Contact: EORTC HQ||+32 2 774 email@example.com|
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