Prostate CancerMCAPNCT05644197
Multidisciplinary Care After Prostatectomy
A study testing Multidisciplinary program in people with Prostate Cancer, run by Provence Private hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 72 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Multidisciplinary program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Multidisciplinary program
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
Secondary outcomes (11)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: Patient adherence will be measured each month during the entire study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Provence Private hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve NEGRE, Psychologist, Study chair, Provence Private hospitalThibault NEGRE, Urologist, Study chair, Provence Private hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644197
- Sponsor's protocol ID
- 2021-A03118-33
- Acronym
- MCAP
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychological, Nutritional and Activity Support Physical on Recovery After Treatment by Prostatectomy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT05644197
- Acronym / sponsor ID
- MCAP / 2021-A03118-33
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Provence Private hospitalUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| intervention group | Other | Other: Multidisciplinary programthe 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 |
| 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 |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary programMultidisciplinary 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. | Other | intervention group |
Primary outcome
Comparison of changes (over time) in quality of life for control and study groups
Time frame: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
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
11 secondary outcomes
Cardiorespiratory fitness assessment
Time frame: From baseline assessments up to 3 weeks after prostatectomy
Physical performance (quadriceps and biceps endurance tests)
Time frame: From baseline assessments up to 3 weeks after surgery
Emotional regulation assessment
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
Time frame: From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention
Well-being assessment
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
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
Time frame: After prostatectomy up to follow up
Patient adherence to nutritional care and support
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
Time frame: After surgery up to follow up: at 3, 6 and 12 months
The quality of physical activity
Time frame: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
Physical Activity commitment
Time frame: Patient adherence will be measured each month during the entire study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve NEGRE, Psychologist study chair
Provence Private hospital
Thibault NEGRE, Urologist study chair
Provence Private hospital
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary program in people with Prostate Cancer, run by Provence Private hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David BARRIOL, Urologist (0685 926 332 ext. +33, david.barriol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of changes (over time) in quality of life for control and study groups (time frame: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 2 Nov 2026.