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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04120298
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT04120298
Ethics application status
Date submitted
12/09/2019
Date registered
9/10/2019
Date last updated
11/05/2023
Titles & IDs
Public title
Effects of Exercise in Patients With Metastatic Breast Cancer
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Scientific title
Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
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Secondary ID [1]
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NL69600.041.19
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Secondary ID [2]
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19-524
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Universal Trial Number (UTN)
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Trial acronym
EFFECT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Supervised exercise
Experimental: Supervised exercise group - 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
No Intervention: Control group - Patients randomized to the control group will also receive an activity tracker (like the intervention group). We 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.
Behaviour: Supervised exercise
An individualised exercise programme supervised by a trained instructor
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cancer-related physical fatigue
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Assessment method [1]
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Physical fatigue measured with the EORTC QLQ-FA12
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Timepoint [1]
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0- 6 months (measured at baseline, 3 and 6 months)
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Primary outcome [2]
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Health-related Quality of Life
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Assessment method [2]
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Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score
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Timepoint [2]
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0- 6 months (measured at baseline, 3 and 6 months)
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Secondary outcome [1]
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Separate HRQoL domains and Summary Score
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Assessment method [1]
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EORTC QLQ-C30 function and symptom scores scores
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Timepoint [1]
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0-9 months
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Secondary outcome [2]
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Cancer-related fatigue
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Assessment method [2]
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EORTC QLQ-FA12 scores
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Timepoint [2]
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0-9 months
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Secondary outcome [3]
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Breast cancer specific symptoms
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Assessment method [3]
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EORTC QLQ-BR45
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Timepoint [3]
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0-9 months
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Secondary outcome [4]
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Anxiety, depression
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Assessment method [4]
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PHQ-4
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Timepoint [4]
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0-9 months
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Secondary outcome [5]
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Sleep
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Assessment method [5]
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PSQI
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Timepoint [5]
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0-9 months
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Secondary outcome [6]
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Pain: severity and its impact on functioning.
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Assessment method [6]
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BPI
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Timepoint [6]
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0-9 months
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Secondary outcome [7]
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Neuropathic pain
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Assessment method [7]
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painDETECT
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Timepoint [7]
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0-9 months
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Secondary outcome [8]
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Pain Catastrophizing
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Assessment method [8]
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PCS
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Timepoint [8]
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0-9 months
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Secondary outcome [9]
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Treatment-related toxicities grade=3
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Assessment method [9]
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Common Toxicity Criteria for adverse events (CTCAE)
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Timepoint [9]
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0-9 months
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Secondary outcome [10]
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Weight
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Assessment method [10]
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weight measured in KG
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Timepoint [10]
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0-6 months
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Secondary outcome [11]
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Height
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Assessment method [11]
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Height measured in meters
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Timepoint [11]
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0-6 months
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Secondary outcome [12]
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Waist circumference
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Assessment method [12]
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waist circumference measured in cm
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Timepoint [12]
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0-6 months
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Secondary outcome [13]
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Body composition (fat free mass and fat mass)
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Assessment method [13]
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Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA
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Timepoint [13]
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0-6 months
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Secondary outcome [14]
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Physical activity (subjective)
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Assessment method [14]
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Questionnaire
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Timepoint [14]
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0-6-9 months
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Secondary outcome [15]
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Physical activity (objective)
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Assessment method [15]
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activity tracker
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Timepoint [15]
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0-6-9 months
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Secondary outcome [16]
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Resting heart rate
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Assessment method [16]
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Resting heart rate
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Timepoint [16]
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0-6 months
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Secondary outcome [17]
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Blood pressure
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Assessment method [17]
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Blood pressure (diastolic and systolic) measured at rest
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Timepoint [17]
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0-6 months
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Secondary outcome [18]
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Physical performance
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Assessment method [18]
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Short Physical Performance Battery, handgrip- and leg strength test
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Timepoint [18]
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0-6 months
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Secondary outcome [19]
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Physical fitness
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Assessment method [19]
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Steep ramp test and endurance cycle test, add-on (not obligatory): CPET
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Timepoint [19]
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0-6 months
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Secondary outcome [20]
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Work status/ healthcare resources consumption
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Assessment method [20]
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iPCQ/iMCQ
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Timepoint [20]
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0-9 months
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Secondary outcome [21]
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Intervention costs
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Assessment method [21]
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Cost analyses
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Timepoint [21]
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0-9 months
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Secondary outcome [22]
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Health status
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Assessment method [22]
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EQ-5D-5L
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Timepoint [22]
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0-9 months
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Secondary outcome [23]
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Satisfaction with exercise intervention
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Assessment method [23]
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Self-developed questionnaire
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Timepoint [23]
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0-9 months
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Secondary outcome [24]
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Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)
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Assessment method [24]
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Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )
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Timepoint [24]
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0-6 months
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Secondary outcome [25]
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Disease control
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Assessment method [25]
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Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry
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Timepoint [25]
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0-9 months
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Secondary outcome [26]
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Cancer treatment
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Assessment method [26]
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The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry
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Timepoint [26]
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0-9 months
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Secondary outcome [27]
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Quality of working life
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Assessment method [27]
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QWLQ-CS (add-on in several centers)
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Timepoint [27]
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0-9 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
357
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Netherlands
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State/province [1]
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Utrecht
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Funding & Sponsors
Primary sponsor type
Other
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Name
UMC Utrecht
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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German Cancer Research Center
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australian Catholic University
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Karolinska Institutet
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Address [3]
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Country [3]
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0
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Other collaborator category [4]
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Other
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Name [4]
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The Netherlands Cancer Institute
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Address [4]
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0
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Country [4]
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0
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Other collaborator category [5]
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Other
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Name [5]
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Medical University of Gdansk
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Address [5]
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Country [5]
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0
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Other collaborator category [6]
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Other
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Name [6]
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Fundación Onkologikoa Fundazioa
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Address [6]
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0
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Country [6]
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0
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Other collaborator category [7]
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Other
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Name [7]
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Europa Donna
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Address [7]
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Country [7]
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0
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Other collaborator category [8]
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Other
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Name [8]
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German Sport University, Cologne
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Address [8]
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Country [8]
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0
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Other collaborator category [9]
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Other
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Name [9]
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University Hospital Heidelberg
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Address [9]
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Country [9]
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0
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Other collaborator category [10]
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Other
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Name [10]
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Nurogames GmbH, Cologne
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Address [10]
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Country [10]
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04120298
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Anne May, PhD
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Address
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UMC Utrecht Julius Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04120298
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Funding & Sponsors
Primary sponsor
Hospital
Primary sponsor name
University Medical Center Utrecht
Primary sponsor address
University Medical Center Utrecht
Heidelberglaan 100
3584 CX Utrecht
Primary sponsor country
Netherlands
Secondary sponsor category [1]
33
University
Name [1]
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Australian Catholic University
Address [1]
33
Mary Mackillop Institute for Health Research Australian Catholic University Level 5 215 Spring Street Melbourne VIC 3000
Country [1]
33
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
15
PETER MACCALLUM CANCER CENTRE HUMAN RESEARCH ETHICS COMMITTEE
Address [1]
15
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne Victoria, 3000
Country [1]
15
Australia
Date submitted for ethics approval [1]
15
29/11/2019
Approval date [1]
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20/02/2020
Ethics approval number [1]
15
HREC/57626/PMCC-2019
Public notes
Contacts
Principal investigator
Title
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Prof
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Name
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Anne May
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Address
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University Medical Center Utrecht Heidelberglaan 100 3584 CX Utrecht
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Country
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Netherlands
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Phone
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0031(0)88 755 11 32
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
162
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Dr
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Name
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Eva Zopf
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Address
162
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Mary MacKillop Institute for Health Research Australian Catholic University Level 5, 215 Spring Street, Melbourne, VIC 3000
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Country
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Australia
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Phone
162
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0392308105
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Fax
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0
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Email
162
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[email protected]
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Contact person for scientific queries
Title
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Dr
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Name
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Eva Zopf
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Address
163
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Mary MacKillop Institute for Health Research Australian Catholic University Level 5, 215 Spring Street, Melbourne, VIC 3000
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Country
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Australia
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Phone
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0392308105
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Fax
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Email
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[email protected]
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