Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Change from baseline Quality of Life at 10 years [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 4 centers
- Ziekenhuisgroep Twente — Almelo
- Alrijne Ziekenhuis — Leiderdorp
- St. Antonius Ziekenhuis — Nieuwegein
- University Medical Center Utrecht — Utrecht
Identifiers
NCT: NCT02839863 · NL52651.041.15