Aim of this study is to assess the effects of exercise intervention on breast cancer patients* quality of life on the short (6 months) and long-term (24 months) according to the cmRCT design and to test the utility of the cmRCT design in the field…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints for this study are: quality of life (primary
patient-related outcome), fatigue, and physical activity levels on the
long-term.
Secondary outcome
Secondary outcomes are methodological: i.e. contamination, participation,
retention and the composition of the study population.
Background summary
The evidence for beneficial effects of exercise training in breast cancer
survivors is growing, however, the long-term effects of structured exercise
programmes are not clear yet. Furthermore, former trials have been performed in
a highly controlled lab setting and included patients comprised a selected
group of relatively young, high educated women who were physically active
before diagnosis. Inclusion of this selected group might have led to
contamination (i.e. control participants adopt the exercise intervention) in
these trials which might have diluted results and explain part of the small
effect sizes found. Exercise-oncology trials also suffer from difficult accrual
since eligible patients do not want to be randomized to the control group. To
overcome these problems, the cohort multiple Randomised Controlled Trial
(cmRCT) is hypothesized be a more suitable design for this field. In a cmRCT,
the intervention study is performed embedded in an on-going prospective cohort
study with regular follow-up measurements. This design also provides an
excellent opportunity to gain long-term results.
Study objective
Aim of this study is to assess the effects of exercise intervention on breast
cancer patients* quality of life on the short (6 months) and long-term (24
months) according to the cmRCT design and to test the utility of the cmRCT
design in the field of exercise oncology.
Study design: Randomized controlled trial, nested within a prospective cohort
(UMBRELLA) according to the *cohort multiple randomized controlled
trial* (cmRCT) design. UMBRELLA is a prospective cohort study including all
breast cancer patients visiting the UMC Utrecht department of Radiotherapy .
Study design
The cohort multiple Randomised Controlled Trial (cmRCT) design
Intervention
A 12-week structured exercise programme, consisting of two one-hour supervised
fitness group sessions at a physiotherapist centre per week. The training
programme is a combination of high intensity endurance training and strength
training.
Study burden and risks
Burden and risk: Patients randomized to the intervention group will be invited
twice for a 2-hour visit to the research center for filling out extra
questionnaires, a physical examination, and several physical tests (at baseline
and at 12-weeks follow-up). Furthermore, patients in the intervention group are
invited to participate in a 12*week exercise program of 2 hours twice weekly.
The estimated extra risk for the patient while participating in this study is
low. To minimize the risk of injuries during exercise, the intensity of the
exercise program will be gradually increased during the study and the program
will be supervised by a physiotherapist. We will try to reduce the burden of
travelling to the training facilities by offering the exercise program by
physiotherapists nearby the patients* home.
Benefit: We expect that the exercise program will have a beneficial effect on
the patients* health status. After study cessation, we will sent all UMBRELLA
participants the results of the study accompanied with an exercise advice.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject should first be included in UMBRELLA. The inclusion criteria of the UMBRELLA cohort are:
- adult women with primary curatively treated breast cancer (stage I-III) visiting the radiotherapy department of the University Medical Center Utrecht
- mentally component to sign informed consent
- able to speak, read and understand Dutch;Specific citeria for the UMBRELLA Fit trial
- 18-75 years of age
- 12 months-18 months after inclusion in the UMBRELLA cohort
- finished primary breast cancer treatment (except hormal therapy)
- an inactive lifestyle
- informed consent given in UMBRELLA for being invited for future research/ intervention studies;An inactive lifestyle is determined as <150 minutes per week performing moderate to intensive (><= 4 MET) leisure time and sports activities/exercise (based on the SQUASH questionnaire).
Exclusion criteria
- contra-indications for exercise, e.g. neurological problems (balance, dizziness), arrhythmias, walking problems and uncontrolled high blood pressure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52062.041.15 |
| OMON | NL-OMON20644 |