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Follow-up in Early and Locally Advanced Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859453
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

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


Contacts
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Contact: EORTC HQ +32 2 774 1611 eortc@eortc.org

Locations
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Germany
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke Recruiting
Wuppertal, Germany
Contact: Vesna Bjelic-Radisic         
Italy
Azienda Ospedaliero-Universitaria Careggi Recruiting
Firenze, Italy
Contact: Icro Meattini         
IRCCS - Istituto Oncologico Veneto Recruiting
Padova, Italy
Contact: Samantha Serpentini         
Poland
The Great Poland Cancer Centre Recruiting
Poznań, Poland
Contact: Joanna Kazmierska         
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         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
More Information
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT03859453    
Other Study ID Numbers: EORTC-1617-QLG-BCG
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases