Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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ETADAPT- Evaluation of the Impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) and Dietetic on the Reproducibility of Radiotherapy Sessions for Prostate Cancers.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Adapted Physical Activity and Dietetic
* Other: conventional management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Therapeutics Education (PTE)<br>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). | Other: Adapted Physical Activity and Dietetic<br>* session in addtion conventional management dietetic, hydratation and physical activity<br>* Other names: Follow-up of Adapted Physical Activity and Dietetic Hydratation;|
| Other: Conventional support<br>Dietary and hydration advices | Other: conventional management<br>* Dietary and hydratation advices according to the recommendations<br>* Other names: conventional management dietary and hydratation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum | Number of uninstallation during the radiotherapy session | An average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency | Rate of patients never uninstalled compared to patients uninstalled during prostate's radiotherapy | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity | Acute gastrointestinal toxicity ≥ grade 2 (NCI- CTCAE V5) | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques | Prescribed laxatives or transit regulation treatments or techniques | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life | 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]) | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the undernutrition | Collection of patients' weight (kg) | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the food intake | Collection of patients' weight (kg) | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the undernutrition | Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything]) | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the food intake | Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything]) | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the undernutrition | Using the Eating and hydration habits questionnaire | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the food intake | Using the Eating and hydration habits questionnaire | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits | Using the Eating and hydration habits questionnaire | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits | Using the Eating and hydration habits questionnaire | An average of 4 months | 
| Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits | Using International Physical Activity Questionnaire (IPAQ) (Description of the physical activity during the last 7 days) | An average of 4 months | 
| Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm) | Using satisfaction questionnaire (scale from 1 [worse evaluation] to 4 [better evaluation]) | An average of 4 months | 
| Evaluate the compliance to APA session recommendations | Daily collection of steps numbers | An average of 4 months | 
| Evaluate the compliance to APA session recommendations | Evaluation during phone calls every 15 days | An average of 4 months | 
| Evaluate the number of patients requiring additional dietetic session | Evaluation during phone calls every 15 days | An average of 4 months | 
| Evaluate the number of patients requiring additional APA session | Evaluation during phone calls every 15 days | An average of 4 months |