Condition or disease |
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Breast Cancer |
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 |
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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: EORTC HQ | +32 2 774 1611 | eortc@eortc.org |
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 |
Tracking Information | |||||
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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 |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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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 |