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This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:
No specific intervention will be performed In the patients randomized in the control group.
Patients randomized in the Intervention group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).
All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep.
In this prospective randomized controlled trial patients with previous breast cancer will be randomized into two treatment arms:
No specific intervention will be performed In the patients randomized in the control group.
Patients randomized in the Intervention Group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).
All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep.
Data will be downloaded in a specific application available online (Garmin Connect).
All the patients will receive written information on the potential benefits of physical exercise and better lifestyle.
At baseline, at the end of the study period (8 weeks) and after 1 year patients will be asked to fill out the following questionnaires:
At baseline, at the end of the study period (8 weeks) patients will be asked to undergo blood draw for serum analysis of insulin, IGF-1, leptin, PCR, cholesterol, triglycerides leucocyte count, T lymphocyte subpopulations (T regulatory and TH17).
The hypothesis of the study is that even a short course of increased physical activity may improve quality of life of non-regular exercisers women with a personal history of breast cancer who completed treatment (endocrine treatment excluded).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Usual Physical Activity | |
| Intervention Group | Experimental | 8-week increased physical activity program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Increased Physical Activity | Behavioral | Patients will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks and an 8-week recreational program of brisk walking/running (3 times a week). |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | questionnaire | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| self-report questionaire of principal side effects of medical treatments | 8 weeks | |
| patients' self-reported perceptions of their cognitive abilities | 37 items consisting of 1) patients' perceived cognitive impair- ments, 2) perceived cognitive abilities, 3) noticeability or com- ments from others, and 4) impact of cognitive changes on quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oreste D Gentilini, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 8 weeks |
| subjective response to a specific traumatic event | administration of self-report validated questionnaire | 8 weeks |
| body weight | Registration of body weight at baseline and 8 weeks | 8 weeks |
| sleep | Registration of movements during sleep (Data registered by the pedometer device) | 8 weeks |
| insulin | serum analysis at baseline and 8 weeks | 8 weeks |
| immune function (as determined by Th17 e T regulators) | serum analysis at baseline and 8 weeks | 8 weeks |
| IGF-1 | serum analysis at baseline and 8 weeks | 8 weeks |
| Leptin | serum analysis at baseline and 8 weeks | 8 weeks |
| C Reactive Protein | serum analysis at baseline and 8 weeks | 8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |