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Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped.
The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.
Patient with cognitive complaint will be randomized in two groups :
APA program contains 10 sessions of APA within five weeks (twice a week). Each session is composed of 5 exercises (each made of 3 serial of 7 repetitions in slow speed).
A cognitive and quality of life assessments will occur in two groups at 3 and 6 months after randomization.
The primary objective of the study is to evaluate the impact of APA program on the improvement of cognitive functions in patients with breast cancer who have been treated by adjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate APA | Experimental | intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization |
|
| Delayed APA | Active Comparator | intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate APA program | Other | 10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result | Proportion of patient with an increase superior or equal to seven points between FACT-COG at the inclusion and FACT-COG after APA program | After APA program |
| Measure | Description | Time Frame |
|---|---|---|
| Improval of quality of life | Impact of APA on quality of life (FACT-B result) | After APA program |
| Comparison of immediate APA and delayed APA on quality of life | Comparison between FACT-B, FACT-COG and FACIT-F results in the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Rigal, MD | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Caen | 14076 | France | |||
| Centre Oscar Lambret |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| delayed APA program | Other | 10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized |
|
| 30 months |
| Study of relations between cognitive functions and quality pf life | Correlation between patient questionnaire and data of psychological tests done by neuropsychologist | After APA program |
| Lille |
| 59000 |
| France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| D017437 |
| Skin and Connective Tissue Diseases |