Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort (UMBRELLA)

February 5, 2024 updated by: Helena M Verkooijen, UMC Utrecht

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Almelo, Netherlands
        • Recruiting
        • Ziekenhuisgroep Twente
        • Contact:
          • Danny Evers, MD PhD
        • Principal Investigator:
          • Danny Evers, MD PhD
      • Leiderdorp, Netherlands
        • Recruiting
        • Alrijne Ziekenhuis
        • Contact:
          • Carmen van de Pol, MD
        • Principal Investigator:
          • Carmen van de Pol, MD
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Annemiek Doeksen, MD,PhD
      • Utrecht, Netherlands, 3508GA
        • Recruiting
        • University Medical Center Utrecht
        • Contact:
        • Sub-Investigator:
          • Sofie A.M. Gernaat, MSc
        • Sub-Investigator:
          • Danny A Young-Afat, MD
        • Contact:
        • Principal Investigator:
          • Helena M Verkooijen, MD, PhD
        • Sub-Investigator:
          • Dieuwke Mink van der Molen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients undergoing radiation treatment

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Inability to understand the Dutch language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Quality of Life at 10 years
Time Frame: 10 years
Assesment of Health-related quality of life in breast cancer patients undergoing radiation
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Helena M Verkooijen, MD, PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Estimated)

October 1, 2053

Study Completion (Estimated)

October 1, 2053

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimated)

July 21, 2016

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL52651.041.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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