Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer
NCT ID: NCT04832113
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
216 participants
INTERVENTIONAL
2021-06-21
2025-04-30
Brief Summary
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The secondary objectives are to evaluate the contribution of Patient's Therapeutic Education (PTE) between the 2 arms on repositionnind during the radiotherapy session, the gastrointestinal toxicity, the need to use laxative or transit regulating treatment or techniques, the quality of life, the undernutrition and food intake, the evolution in eating/hydratation and physical habits.
For the experimetal arm, the satisfaction and the compliance with PTE program will be evaluated, as well as the need of additionnal use of dietary and APA consultations.
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Detailed Description
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* Reproductibility of patient's positioning (requiring management of bladder and rectal fillings at each session).
* An image-guided treatment consisting in acquiring an image before each session. This pre-treatment Imaging allows the optimal adjustment of the target volume and organs at risk (bladder and rectum).
To allow reproductibility of target volume positioning at each radiotherapy session, it's recommended to have an empty rectum at the time of the radiotherapy preparation scan, and to check repletion before each session.
It's recommended that the patient has a comfortably full bladder to limit the volume of irradiated bladder mucosa. The radiotherapy teams don't have any recommendations concerning the rectum and manage this problem session by session, according to the repositioning Imaging of the current day.
According to a pilot study carried out in 2017 in the radiotherapy department of the Léon Bérard center, an intervention for a dilated rectum (probe or laxative) was necessary for an average of 25% of session per patient.
These rectal problems can be partly explained by the age (60-80 years) and sedentary lifestyle of patients with prostate cancer. Physical activities, adapted hydratation and changes in eating habits are an integral part of the constipation and flatulence prevention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patient Therapeutics Education (PTE)
Educational diagnosis prior radiotherapy and participation to Patient Therapeutics Education (PTE) in Adapted Physical Activity (APA) and dietetic sessions. In addition to conventional support (dietary and hydration advice).
Adapted Physical Activity and Dietetic
session in addtion conventional management dietetic, hydratation and physical activity
Conventional support
Dietary and hydration advices
conventional management
Dietary and hydratation advices according to the recommendations
Interventions
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Adapted Physical Activity and Dietetic
session in addtion conventional management dietetic, hydratation and physical activity
conventional management
Dietary and hydratation advices according to the recommendations
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
I2: Patient with prostatic adenocarcinoma with indication for first-line or post-operative radiotherapy (adjuvant or biologic recurrence).
I3: Patient able to practice a physical activity (certificate of aptitude for adapted physical activity).
I4: Life expectancy greater than 6 months.
I5: Absence of chronic inflammatory intestinal disease or intestinal surgery.
I6: Signed informed consent.
I7: Patient covered by a medical insurance.
I8. At least 20 sessions of radiotherapy planned
Exclusion Criteria
E2: Patient followed for a psychiatric pathology or presenting cognitive disorders.
E3: Inability to comply with study follow-up goegraphical, social or psychological reasons.
E4: Patient requiring tutorship or curatorship or patient deprived of liberty.
E5: Participation to another clinical trial which may interfere with principal Endpoint assessment.
18 Years
MALE
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Pascale Roux
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Chu de saint etienne
Saint-Etienne, Rhône-Alpes Auvergne, France
Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD
Grenoble, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Eugène Marquis
Rennes, , France
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, , France
Countries
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Central Contacts
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Facility Contacts
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Thomas REYNAUD, MD
Role: primary
Role: backup
Other Identifiers
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ET20-0284 ETADAPT
Identifier Type: -
Identifier Source: org_study_id
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