Multidisciplinary Care After Prostatectomy

NCT05644197 | Unknown

• 1 other identifier: 2021-A03118-33
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of changes (over time) in quality of life for control and study groups

  The program will focus on changes in quality of life. Quality of life will be measured using a questionnaire. Comparaison of changes in quality of life for control and study groups: Between patients treated with prostatectomy receiving either a standard or a multimodal therapy. At several time points during the study period, from baseline assessments(T0) up to follow up:3,6 and 12 months after start of intervention, using the Functional Assessments of Cancer Therapy-Prostate (FACT-P) questionnaire. With higher score correlating with better quality of life. Adapted Physics) at 3, 6, and 12 months will be studied using a model linear mixed

  At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention

Secondary Outcomes (11)

• Cardiorespiratory fitness assessment

  From baseline assessments up to 3 weeks after prostatectomy

• Physical performance (quadriceps and biceps endurance tests)

  From baseline assessments up to 3 weeks after surgery

• Emotional regulation assessment

  3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention

• Anxiety assessment-Self reported anxiety level

  From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention

• Well-being assessment

  From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention

Study Arms (2)

intervention group

OTHER

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

Other: Multidisciplinary program

control group

NO INTERVENTION

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

Interventions

Multidisciplinary program OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Provence Private hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Eve NEGRE, Psychologist

  Provence Private hospital

  STUDY CHAIR

• Thibault NEGRE, Urologist

  Provence Private hospital

  STUDY CHAIR

Central Study Contacts

David BARRIOL, Urologist

CONTACT

0685 926 332; david.barriol@gmail.com

Salima DELLYS, CRA

CONTACT

0442 3 17 64; arc.hpp@ppr13.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 9, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: December 9, 2022

Record last verified: 2022-11