Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
UMBRELLA
1 other identifier
observational
10,000
1 country
4
Brief Summary
Due to better treatment options and earlier detection, survival rates of patients with breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life and the cosmetic outcome are becoming more important. Also, many competing experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are being developed, all in need to be properly evaluated before being implemented in routine clinical care. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard. By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the investigators aim to:
- provide an infrastructure for efficient, fast and pragmatic evaluation and implementation of experimental interventions
- gain insight into short and long-term treatment response, toxicity, complications, quality of life and survival of patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2053
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2053
February 6, 2024
February 1, 2024
40 years
May 27, 2016
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline Quality of Life at 10 years
Assesment of Health-related quality of life in breast cancer patients undergoing radiation
10 years
Eligibility Criteria
Breast cancer patients undergoing radiation treatment
You may qualify if:
- Age ≥ 18 years
- Patients with breast cancer who undergo irradiation in the UMC Utrecht
- Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.
You may not qualify if:
- Inability to understand the Dutch language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (4)
Ziekenhuisgroep Twente
Almelo, Netherlands
Alrijne Ziekenhuis
Leiderdorp, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
University Medical Center Utrecht
Utrecht, 3508GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helena M Verkooijen, MD, PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 27, 2016
First Posted
July 21, 2016
Study Start
October 1, 2013
Primary Completion (Estimated)
October 1, 2053
Study Completion (Estimated)
October 1, 2053
Last Updated
February 6, 2024
Record last verified: 2024-02