The purpose of the EFFECT study is to assess the effects of a structured and individualised 9-month exercise intervention in patients with metastatic breast cancer. We will look at the effects on fatigue, quality of life, and other disease and…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints of the EFFECT study are
1) Cancer-related physical fatigue (EORTC QLQ-FA12)
2) Health-related Quality of Life (EORTC QLQ-C30 Summary Score)
Secondary outcome
• Separate HRQoL domains (EORTC QLQ-C30 function and symptom
scores)
• Breast cancer specific symptoms (EORTC QLQ-BR45)
• Emotional, cognitive, and total fatigue scores (EORTC QLQ-FA12)
• Anxiety, depression (PHQ-4)
• Sleep (PSQI)
• Pain (BPI, painDETECT, PCS)
• Treatment-related toxicities grade>=3 (Common Toxicity Criteria for
adverse events (CTCAE)
• Physical fitness/performance (Steep ramp test; endurance test; 5-times sit to
stand test; short version of the Fullerton Advanced Balance (FAB) scale;
handgrip- and leg strength test and in some centers also Cardiopulmonary
exercise testing (CPET))
• Body composition (Bio impedance, anthropometrics; and in some centers also
DEXA))
• Physical activity levels (questionnaire / activity tracker)
• Profiling of circulating white blood cell populations and biomarkers
(e.g., systemic inflammation, growth factors, blood/brain barrier modulators)
• Cost-effectiveness (iPCQ/iMCQ)/EQ-5D)
• Quality of working life (add-on in several centers)
Background summary
Exercise has been established to be safe and to have a positive effect on
disease and treatment-related side effects in patients with non-metastasized
cancer. In people undergoing breast cancer treatment for early, localised
disease, exercise has shown positive results in terms of reducing fatigue, but
also in improving psychological symptoms, such as depression. For patients with
metastatic breast cancer, there is limited information on the potential effects
of exercise. It might be possible that exercise yields similar effects on
fatigue and quality of life in metastatic breast cancer patients, but this is
currently unknown.
Study objective
The purpose of the EFFECT study is to assess the effects of a structured and
individualised 9-month exercise intervention in patients with metastatic breast
cancer. We will look at the effects on fatigue, quality of life, and other
disease and treatment-related side effects.
Study design
The EFFECT study is a multicentre, randomised controlled trial.
Intervention
The intervention group will participate in a 9-month exercise program. The
exercise program will be progressive and modified according to the participants
fitness level and how the participant tolerates the exercise.
For the first six months, the participant will receive two supervised exercise
sessions per week. Each session will take approximately 60 minutes and will be
supervised by experienced exercise specialists. The program involves
resistance, aerobic and balance exercises. After six months, one supervised
session will be replaced by an unsupervised session for the last three months.
Throughout the 9-month program, the participant will be encouraged to undertake
unsupervised exercise with the goal of achieving at least 30 minutes of
exercise per day (excluding the days on which the participant attends
supervised exercise sessions). Unsupervised exercise will be supported by an
activity tracker (Fitbit) and an exercise App especially designed for this
study.
If it is not possible to exercise or continue exercising under supervision due
to exceptional external circumstances or due to the patient*s health condition,
the study team will provide the required training equipment at home and a
detailed home-based exercise program. To ensure a safe execution of the
program, the study team or exercise specialist will monitor the progression of
the participant by (video)calling the participant at least once per week. They
will also offer the participant to conduct one or more (if needed) training
sessions under supervision of an exercise specialist via videocall or a home
visit to make sure that all exercises are performed correctly.
Participants in the controlgroup will receive the activity tracker and an
exercise advice to stimulate an active lifestyle.
Study burden and risks
Because there are no additional medical procedures involved in this project,
there are no foreseeable major risks or side-effects associated with
participation. However, as is the case with anyone who exercises, exercise may
result in temporary mild discomfort and muscle soreness. Furthermore, during
exercise it is possible to experience symptoms such as fainting,
light-headedness and/or nausea.
There is also the possibility of muscle pulls or strains associated with the
exercise program, as with any type of physical activity. In order to minimise
these risks the participant will perform an adequate warm-up and cool-down
before and after any exercise bout, be comprehensively instructed on the
correct lifting technique, thoroughly familiarised with the movements involved
in this investigation and supervised by qualified professionals. Our exercise
programme takes into account that patients might have bone metastases.
Other potential risks of study participation:
- Drawing blood may be painful and/or cause some bruising.
- Incidental findings can arise in the different measurements (e.g. blood
pressure measurement), which will be reported to participants and their
treating physician.
Participating in this study demands some time commitment, especially for the
intervention group. Participants in the intervention group will take part in a
9-month exercise program involving up to two supervised exercise sessions per
week. Additionally, participants in the intervention group are encouraged to be
active for at least 30 minutes per day on all other days. The exercise program
will be offered to the participant at no cost; however, the participant will
have to travel to the exercise facilities at their own cost. The burden of
travelling to the training facilities will be reduced by offering the exercise
program at locations convenient to the participant.
All participants are required to visit the study centre three times over a
6-month period for assessments. Each visit will take 3-4 hours. Travelling to
the study centres will be reimbursed.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04120298 |
| CCMO | NL69600.041.19 |