Clinical trial NCT05644197: Multidisciplinary Care After Prostatectomy
Official title: Effect of Psychological, Nutritional and Activity Support Physical on Recovery After Treatment by Prostatectomy for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Provence Private hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the two groups will be followed in parallel, intervention group composed of 50 patients and control group composed of 50 patients, the duration of participation for each patient is 15 months
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of changes (over time) in quality of life for control and study groups
timeFrame: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
Secondary outcomes:
measure: Cardiorespiratory fitness assessment
timeFrame: From baseline assessments up to 3 weeks after prostatectomy
measure: Physical performance (quadriceps and biceps endurance tests)
timeFrame: From baseline assessments up to 3 weeks after surgery
measure: Emotional regulation assessment
timeFrame: 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
measure: Anxiety assessment-Self reported anxiety level
timeFrame: From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
measure: Well-being assessment
timeFrame: From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
measure: Psychological distress (in terms of depression and anxiety) assessment
timeFrame: From 3 weeks after prostatectomy up to follow up:3, 6 and 12 months after start of intervention
measure: Nutritional assessment/Nutrition-related variables
timeFrame: After prostatectomy up to follow up
measure: Patient adherence to nutritional care and support
timeFrame: From 3 weeks after prostatectomy up to 3 months after start of intervention and in the empowerment process at 6 and 12 months
measure: Assessing physical performance
timeFrame: After surgery up to follow up: at 3, 6 and 12 months
measure: The quality of physical activity
timeFrame: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
measure: Physical Activity commitment
timeFrame: Patient adherence will be measured each month during the entire study.
Other outcomes:
Locations:
Study officials:
affiliation: Provence Private hospital
name: Eve NEGRE, Psychologist
role: STUDY_CHAIR
affiliation: Provence Private hospital
name: Thibault NEGRE, Urologist
role: STUDY_CHAIR
References: