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JOURNAL ONKOLOGIE – STUDIE

Follow-up in Early and Locally Advanced Breast Cancer Patients

Rekrutierend

NCT-Nummer:
NCT03859453

Studienbeginn:
Oktober 2020

Letztes Update:
23.12.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC

Collaborator:
-

Kontakt

Studienlocations (3 von 7)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Health-related quality of life (Time Frame - 18 months after first patient inclusion):
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

2. 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

3. 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

4. Health-related quality of life (Time Frame - 18 months after first patient inclusion):
It will be evaluated using self-administered EORTC Sexual Health Questionnaire

5. Health-related quality of life (Time Frame - 18 months after first patient inclusion):
It will be evaluated using self-administered Distress Thermometer

Quelle: ClinicalTrials.gov


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