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

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT02839863
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2053-10
• Study Completion: 2053-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Quality of Life at 10 years	10 years	Assesment of Health-related quality of life in breast cancer patients undergoing radiation

Trial Locations

Locations (4)

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands

Alrijne Ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands