Actively Recruiting

Age: 18Years +
All Genders
NCT02839863

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

Led by UMC Utrecht · Updated on 2024-02-06

10000

Participants Needed

4

Research Sites

2087 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years
  • Patients with breast cancer who undergo irradiation in the UMC Utrecht
  • Informed consent for use of routinely collected clinical data and to fill out questionnaires
Not Eligible

You will not qualify if you...

  • Inability to understand the Dutch language

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Ziekenhuisgroep Twente

Almelo, Netherlands

Actively Recruiting

2

Alrijne Ziekenhuis

Leiderdorp, Netherlands

Actively Recruiting

3

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Actively Recruiting

4

University Medical Center Utrecht

Utrecht, Netherlands, 3508GA

Actively Recruiting

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Research Team

H

Helena M Verkooijen, MD, PhD

CONTACT

D

Danny A Young-Afat, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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