Breast Cancer, Reasoning, and Activity Intervention
NCT04816006
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT02839863
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ziekenhuisgroep Twente, Almelo, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years
Assesment of Health-related quality of life in breast cancer patients undergoing radiation
Contact information is provided by the study sponsor or research team.
Danny A Young-Afat, MD
CONTACT
Helena M Verkooijen, MD, PhD
CONTACT
UMC Utrecht
Other
Acronym: UMBRELLA
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