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Follow-up in Early and Locally Advanced Breast Cancer Patients

Study Description
Brief Summary:
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.

Condition or disease
Breast Cancer

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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 830 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: EORTC HQ +32 2 774 1611 eortc@eortc.org

Locations
Layout table for location information
Germany
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke Recruiting
Wuppertal, Germany
Contact: Vesna Bjelic-Radisic         
Italy
Ospedale Generale Regionale Recruiting
Bolzano, Italy
Contact: Elisabetta Cretella         
Azienda Ospedaliero-Universitaria Careggi Recruiting
Firenze, Italy
Contact: Icro Meattini         
IRCCS - Istituto Oncologico Veneto Recruiting
Padova, Italy
Contact: Samantha Serpentini         
Netherlands
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis Recruiting
Amsterdam, Netherlands
Contact: Frederieke van Duijnhoven         
Poland
The Great Poland Cancer Centre Recruiting
Poznań, Poland
Contact: Joanna Kazmierska         
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology Recruiting
Warsaw, Poland
Contact: Katarzyna Pogoda         
Spain
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain
Contact: Amalia Palacios Eito         
Clinica Universidad de Navarra Recruiting
Madrid, Spain
Contact: Isabel Rubio         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Eva Fernandez Lizarbe         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Contact: Juan I. Arraras         
Switzerland
Group Of Private Clinics Hirslanden - Hirslanden Klinik-Tumor Zentrum Aarau Recruiting
Aarau, Switzerland
Contact: Razvan Popescu         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Tracking Information
First Submitted Date February 28, 2019
First Posted Date March 1, 2019
Last Update Posted Date April 2, 2021
Actual Study Start Date October 14, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up in Early and Locally Advanced Breast Cancer Patients
Official Title Follow-up in Early and Locally Advanced Breast Cancer Patients
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2019)
830
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: EORTC HQ +32 2 774 1611 eortc@eortc.org
Listed Location Countries Germany,   Italy,   Netherlands,   Poland,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03859453
Other Study ID Numbers EORTC-1617-QLG-BCG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators Not Provided
Investigators Not Provided
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date March 2021

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