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NCT Number: NCT02839863

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuisgroep Twente, Almelo, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Danny A Young-Afat, MD

CONTACT

[email protected]

Helena M Verkooijen, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Acronym: UMBRELLA

Important dates

Study start
2013
Primary completion
2053
Study completion
2053
First posted
Jul 21, 2016
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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