NCT04120298

Effects of Exercise in Patients With Metastatic Breast Cancer

Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine. Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Supervised exercise	An individualised exercise programme supervised by a trained instructor

Timeline

• Start date: 2020-01-08
• Primary completion: 2023-02-28
• Completion: 2027-07-01
• First posted: 2019-10-09
• Last updated: 2023-12-06

Locations

1 site across 1 country: Netherlands