EFFECT The effect of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life

Completed

Conditions: metastasized breast cancer
stage IV mamma carcinoma
10027656

Registration Number: NL-OMON54585

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 88

Inclusion Criteria

• Age >= 18 years
• Diagnosis of breast cancer stage IV
• ECOG (Eastern Cooperative Oncology Group scale) performance status <= 2
• Able and willing to perform the exercise program and wear the activity
tracker

Exclusion Criteria

• Unstable bone metastases inducing skeletal fragility as determined by the
treating clinician
• Untreated symptomatic known brain metastasis
• Estimated life expectancy < 6 months as determined by the treating clinician
• Serious active infection
• Too physically active (i.e. >210 minutes/week of moderate-to-vigorous
intentional exercise, or engaging in intense exercise training comparable to
the EFFECT exercise program
• Severe neurologic or cardiac impairment according ASCM criteria
• Uncontrolled severe respiratory insufficiency as determined by the treating
clinician or if the patient is dependent on oxygen suppletion in rest or during
exercise
• Uncontrolled severe pain
• Any other contraindications for exercise as determined by the treating
physician
• Any circumstances that would impede adherence to study requirements or
ability to give informed consent, as determined by the treating clinician
• Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints of the EFFECT study are<br /><br>1) Cancer-related physical fatigue (EORTC QLQ-FA12)<br /><br>2) Health-related Quality of Life (EORTC QLQ-C30 Summary Score)</p><br>

Secondary Outcome Measures