The effect of exercise on breast cancer patients* quality of life using the cmRCT design: The UMBRELLA Fit trial
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON47246
- Lead Sponsor
- Jullius Centrum voor Gezondheidswetenschappen en Eerstelijnsgeneeskunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
In order to be eligible to participate in this study, a subject should first be included in UMBRELLA. The inclusion criteria of the UMBRELLA cohort are:
- adult women with primary curatively treated breast cancer (stage I-III) visiting the radiotherapy department of the University Medical Center Utrecht
- mentally component to sign informed consent
- able to speak, read and understand Dutch;Specific citeria for the UMBRELLA Fit trial
- 18-75 years of age
- 12 months-18 months after inclusion in the UMBRELLA cohort
- finished primary breast cancer treatment (except hormal therapy)
- an inactive lifestyle
- informed consent given in UMBRELLA for being invited for future research/ intervention studies;An inactive lifestyle is determined as <150 minutes per week performing moderate to intensive (><= 4 MET) leisure time and sports activities/exercise (based on the SQUASH questionnaire).
- contra-indications for exercise, e.g. neurological problems (balance, dizziness), arrhythmias, walking problems and uncontrolled high blood pressure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints for this study are: quality of life (primary<br /><br>patient-related outcome), fatigue, and physical activity levels on the<br /><br>long-term. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are methodological: i.e. contamination, participation,<br /><br>retention and the composition of the study population. </p><br>