Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: Adapted Physical Activity and DieteticOther: conventional management
- Registration Number
- NCT04832113
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe).
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.
- Detailed Description
Prostate cancer is the 3rd cause of cancer mortality in patient aged over 50 years. Radiotherapy treatment plans require specific conditions:
* 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 216
I1: Age >= 18 years old.
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
E1: Patient does not understand and cannot read French.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Therapeutics Education (PTE) Adapted Physical Activity and Dietetic 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). Conventional support conventional management Dietary and hydration advices
- Primary Outcome Measures
Name Time Method Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum An average of 4 months Number of uninstallation during the radiotherapy session
- Secondary Outcome Measures
Name Time Method Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques An average of 4 months Prescribed laxatives or transit regulation treatments or techniques
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition An average of 4 months Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity An average of 4 months Acute gastrointestinal toxicity ≥ grade 2 (NCI- CTCAE V5)
Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits An average of 4 months Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits An average of 4 months Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life An average of 4 months Using European Organisation for Research and Treatment of Cancer - Core Quality of life questionnaire (QLQC30) (Evaluation of patient's quality of life during the last 7 days - From 4 \[worse reply\] to 1 \[better reply\])
Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits An average of 4 months Using International Physical Activity Questionnaire (IPAQ) (Description of the physical activity during the last 7 days)
Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency An average of 4 months Rate of patients never uninstalled compared to patients uninstalled during prostate's radiotherapy
Evaluate the contribution of Patient's Therapeutic Education on the food intake An average of 4 months Using the "Eating and hydration habits questionnaire"
Evaluate the number of patients requiring additional APA session An average of 4 months Evaluation during phone calls every 15 days
Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm) An average of 4 months Using satisfaction questionnaire (scale from 1 \[worse evaluation\] to 4 \[better evaluation\])
Evaluate the compliance to APA session recommendations An average of 4 months Evaluation during phone calls every 15 days
Evaluate the number of patients requiring additional dietetic session An average of 4 months Evaluation during phone calls every 15 days
Trial Locations
- Locations (5)
Centre Eugène Marquis
🇫🇷Rennes, France
Chu de saint etienne
🇫🇷Saint-Étienne, Rhône-Alpes Auvergne, France
Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD
🇫🇷Grenoble, France
Institut de Cancérologie de l'Ouest René Gauducheau
🇫🇷Saint-Herblain, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France