Multidisciplinary Care After Prostatectomy (MCAP)

Provence Private hospital

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Other: Multidisciplinary program

Study type: Interventional

Funder types: Other

Identifiers

NCT05644197

2021-A03118-33

Details and patient eligibility

About

This is a pilot, prostective, comparative, randomized, monocentric open-label study whose main objective is to determine whether appropriate psychological, nutritional and physical activity support can improve the quality of life of carrier patients. localized prostate cancer treated by prostatectomy

Full description

Pilot study to demonstrate the benefits of a multimodal intervention (psychological and nutritional support and physical activity) on the recovery of patients treated by prostatectomy for localized prostate cancer.

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

WHO score 0 or 1

• 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

WHO score greater than or equal to 2

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

intervention group

Other group

Description:

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

Treatment:

Other: Multidisciplinary program

control group

No Intervention group

Description:

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