Multidisciplinary Care After Prostatectomy (MCAP)

Effect of Psychological, Nutritional and Activity Support Physical on Recovery After Treatment by Prostatectomy for Localized Prostate Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Multidisciplinary program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David BARRIOL, Urologist; Phone Number: +33 0685 926 332; Email: david.barriol@gmail.com
• Study Contact Backup: Name: Salima DELLYS, CRA; Phone Number: +33 0442 3 17 64; Email: arc.hpp@ppr13.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness assessment	Changes in cardiorespiratory fitness for all patients from baseline assessments up to 3 weeks after prostatectomy assessed either by the Luc Léger's Shuttle test or TM6, depending on the patient conditions. (m.s-1, /m.s)	From baseline assessments up to 3 weeks after prostatectomy
Physical performance (quadriceps and biceps endurance tests)	Changes in quadriceps and biceps strength for each individual patient from baseline assessments up to 3 weeks after surgery assessed by 2 items comprising the senior fitness test:- Quadriceps endurance test: The 30-Second Chair Stand or Sit to Stand Test/item for measuring lower body strength (Number of full stands that can be completed in 30 seconds with arms crossed at the wrists and held against the chest). -Biceps endurance test: The Arm Curl item for measuring upper body strength (Number of bicep curls that can be completed in 30 seconds holding a hand weight of 7.7 (3.5 kg), one arm at a time.	From baseline assessments up to 3 weeks after surgery
Emotional regulation assessment	Changes in emotion regulation strategies for each individual patient 3 weeks after prostatectomy up to follow up: 3 ,6 and 12 months after start of intervention using the cognitive emotional regulation questionnaire (CERQ). Higer score indicating greater difficulty in emotion regulation.	3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
Anxiety assessment-Self reported anxiety level	Changes in anxiety level for each individual patient from 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention using the State Trait Inventory (STAI Y1 and Y2). Patients will be asked to score a series of questions split into the S-Anxiety scale that requires the participants to describe how they feel at this moment, and the T-Anxiety scale to describe how they generally feel, on a 4-pointscale. With higher scores indicating greater anxiety.	From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
Well-being assessment	Changes in psychological well-being (change in scores) for each individual patient from 3 weeks after prostatectomy up to follow up: 3,6 and 12 months after start of intervention using the Ryff Scales of Psychological Welle-being. Patients will be asked to rate how strongly they agree or disagree with 18 statements in 6 areas (autonomy, Environnemental Mastery, Personal Growth, Positive Relations with Others, Purpose in life, Self-acceptance) using a 6- point scale (1 = strongly agree; 6 = strongly disagree) with higher score indicating a better outcome.	From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
Psychological distress (in terms of depression and anxiety) assessment	Changes in anxiety and/or depression symptoms (change in scores) for each individual patient from 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention using the Hospital Anxiety and Depression Scale (HADS). Higher score indicating greater levels of anxiety or depression	From 3 weeks after prostatectomy up to follow up:3, 6 and 12 months after start of intervention
Nutritional assessment/Nutrition-related variables	Changes in nutritional parameters for each individual patient after prostatectomy up to up follow up using the Subjective Global Assessment (SGA); the acquisition of knowledge of the people treated with regard to food and its daily management as well as their behavior when using the tools (the different food groups, their roles, consumption benchmarks, knowledge of foods rich in energy, foods rich in protein...) by means of questionnaires.; improvement of nutritional status parameters	After prostatectomy up to follow up
Patient adherence to nutritional care and support	Patient adherence level during the supportive care intervention phase from 3 weeks after prostatectomy up to 3 months after start of intervention and in the empowerment process at 6 and 12 months, using the Subjective Global Assessment (SGA)	From 3 weeks after prostatectomy up to 3 months after start of intervention and in the empowerment process at 6 and 12 months
Assessing physical performance	Changes in physical performance for each individual patient after surgery up to follow up: at 3, 6 and 12 month using the Luc Léger's Shuttle test or TM6.	After surgery up to follow up: at 3, 6 and 12 months
The quality of physical activity	The quality of physical activity during the program will be assessed for each individual patient from baseline assessments up to 3 weeks after prostatectomy up to follow up:3, 6 and 12 months after start of intervention using the International Physical Activity questionnaire. Patients will be asked to score a series of questions (frequency =number of days per week; duration (in minutes)) in 3 specific types of activities (Walking, moderate-intensity and vigorous-intensity activities). Undertaken in 4 domains (leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity). With higher score correlation with higher levels of physical activity	At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
Physical Activity commitment	Patient engagement/adherence as a measure of Physical Activity commitment. Patient adherence will be measured each month during the entire study period 1) using Heart Rate Monitors/real-time heart rate feedback, 2) measuring daily energy expenditure, 3) comparing the number of sessions and duration of exercise par week with the recommended amount of weekly activity and 4) assessing session perceived exertion using the visual analog scale (vas)	Patient adherence will be measured each month during the entire study.

Collaborators and Investigators

• Sponsor: Provence Private hospital
• Investigators: Study Chair: Eve NEGRE, Psychologist, Provence Private hospital; Study Chair: Thibault NEGRE, Urologist, Provence Private hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2021-A03118-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No