Supervised exercise: An individualised exercise programme supervised by a trained instructor
Study summary
Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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:
* A potential subject who meets any of the following criteria is not eligible for enrolment into this study:
* 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
* Severe neurologic or cardiac impairment according ACSM 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
Primary outcome measure(s)
Cancer-related physical fatigue — 0- 6 months (measured at baseline, 3 and 6 months) Physical fatigue measured with the EORTC QLQ-FA12
Health-related Quality of Life — 0- 6 months (measured at baseline, 3 and 6 months) Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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