An interventional study of Multidisciplinary program in Prostate Cancer, sponsored by Provence Private hospital. Not yet recruiting. Open to male participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by Provence Private hospital · Not applicable, Interventional, and Supportive care
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
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Provence Private hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
WHO score 0 or 1
Exclusion Criteria:
WHO score greater than or equal to 2
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
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
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.
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
Time frame: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: Patient adherence will be measured each month during the entire study.
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