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
Kontakt:
Phone: +32 2 774 1611
E-Mail: eortc@eortc.org» Kontaktdaten anzeigen
Studienlocations (3 von 7)
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vesna Bjelic-Radisic» Ansprechpartner anzeigenAzienda Ospedaliero-Universitaria Careggi
Firenze
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Icro Meattini» Ansprechpartner anzeigenIRCCS - Istituto Oncologico Veneto
Padova
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Samantha Serpentini» Ansprechpartner anzeigen
Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vesna Bjelic-Radisic» Ansprechpartner anzeigenAzienda Ospedaliero-Universitaria Careggi
Firenze
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Icro Meattini» Ansprechpartner anzeigenIRCCS - Istituto Oncologico Veneto
Padova
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Samantha Serpentini» Ansprechpartner anzeigen
The Great Poland Cancer Centre
Poznań
PolandRekrutierend» Google-Maps
Ansprechpartner:
Joanna Kazmierska» Ansprechpartner anzeigenHospital Universitario Reina Sofia
Córdoba
SpainRekrutierend» Google-Maps
Ansprechpartner:
Amalia Palacios Eito» Ansprechpartner anzeigenClinica Universidad de Navarra
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Isabel Rubio» Ansprechpartner anzeigenHospital Universitario Ramon y Cajal
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Eva Fernandez Lizarbe» Ansprechpartner anzeigen
Alle anzeigen Poznań
PolandRekrutierend» Google-Maps
Ansprechpartner:
Joanna Kazmierska» Ansprechpartner anzeigenHospital Universitario Reina Sofia
Córdoba
SpainRekrutierend» Google-Maps
Ansprechpartner:
Amalia Palacios Eito» Ansprechpartner anzeigenClinica Universidad de Navarra
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Isabel Rubio» Ansprechpartner anzeigenHospital Universitario Ramon y Cajal
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Eva Fernandez Lizarbe» Ansprechpartner 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