Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2023-01-31
2026-01-31
Brief Summary
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Detailed Description
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After inclusion of 100 patients, at week 6 will undergo a prostatectomy and then at week 9 will be randomized into two groups of 50 patients for each group.
Groupe Intervention which will benefit from multidisciplinary care over 12 weeks (one APA session per week plus 5 workshops with the psychologist and a workshop with the dietician) plus a visit with the urologist.
Then after 3 months, 6 months and 12 months, the group benefit from an evaluation with the urologist, the teacher of adapted physical activity and the dietitian.
-For the control group, it will be followed classically, a visit to the urologist, an assessment with the teacher of physical activity and the dietician, after prostatectomy, then at 3 months, 6 months and at 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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intervention group
the intervention group of 50 patients will undergo a support program over 12 weeks (1 adapted physical activity session per week, will participate in 5 workshops with the psychologist and 1 workshop with the dietician, plus a visit with the urologist after 6 weeks from prostatectomy
Multidisciplinary program
Multidisciplinary program:
* APA interventions: 12 weeks Each week at home, cardio-respiratory endurance sessions for muscle strengthening and balance work from the Autohome interface (Neuradom) and one week supervised by an APA teacher.
* Nutrition interventions: A group nutrition workshop at the Hôpital Privé de Provence.
* Psychological intervention:
5 sessions of 1h30 in group, the first session will take place at the Private Hospital of Provence and the others by videoconference.
An individual session the week following the last group session.
-Visit with the urologist, 5 weeks after the prostatectomy.
control group
the control group will only undergo a classic follow-up during its 12 weeks, namely a visit to the urologist after 6 weeks of the prostatectomy
No interventions assigned to this group
Interventions
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Multidisciplinary program
Multidisciplinary program:
* APA interventions: 12 weeks Each week at home, cardio-respiratory endurance sessions for muscle strengthening and balance work from the Autohome interface (Neuradom) and one week supervised by an APA teacher.
* Nutrition interventions: A group nutrition workshop at the Hôpital Privé de Provence.
* Psychological intervention:
5 sessions of 1h30 in group, the first session will take place at the Private Hospital of Provence and the others by videoconference.
An individual session the week following the last group session.
-Visit with the urologist, 5 weeks after the prostatectomy.
Eligibility Criteria
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Inclusion Criteria
* Adult patients with localized prostate cancer eligible for surgical treatment according to the AFU criteria following the CAPRA and d'Amico classifications: low risk or risk intermediaries. These are patients under the age of 73, with clinical stage and or MRI \< or = T3, PSA \< or = 20 ng/ml, with assessment negative extension (bone scintigraphy, thoraco-abdomino-pelvic scanner, Choline Pet-scanner)
* Informed and written consent signed by the patient
* Person affiliated with social security or beneficiary of such a scheme
Exclusion Criteria
* MMSE score below 20
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to a legal protective measure)
18 Years
72 Years
MALE
No
Sponsors
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Provence Private hospital
OTHER
Responsible Party
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Principal Investigators
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Eve NEGRE, Psychologist
Role: STUDY_CHAIR
Provence Private hospital
Thibault NEGRE, Urologist
Role: STUDY_CHAIR
Provence Private hospital
Central Contacts
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Other Identifiers
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2021-A03118-33
Identifier Type: -
Identifier Source: org_study_id