Effects of Exercise in Patients With Metastatic Breast Cancer (NCT04120298) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Exercise in Patients With Metastatic Breast Cancer
Netherlands357 participantsStarted 2020-01-08
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cancer-related physical fatigue
Timeframe: 0- 6 months (measured at baseline, 3 and 6 months)
2
Health-related Quality of Life
Timeframe: 0- 6 months (measured at baseline, 3 and 6 months)