Prostate Cancer
Conditions
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.
Interventions
OTHERAdapted Physical Activity and Dietetic
session in addtion conventional management dietetic, hydratation and physical activity
Dietary and hydratation advices according to the recommendations
Sponsors
Centre Leon Berard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 undernutrition | An average of 4 months | Collection of patients' weight (kg) |
| Evaluate the contribution of Patient's Therapeutic Education on the food intake | An average of 4 months | Collection of patients' weight (kg) |
| 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 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 | Daily collection of steps numbers |
| Evaluate the number of patients requiring additional dietetic session | An average of 4 months | Evaluation during phone calls every 15 days |
| Evaluate the number of patients requiring additional APA session | An average of 4 months | Evaluation during phone calls every 15 days |
| 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 |
Countries
France
Contacts
Primary ContactSéverine METZGER
Backup ContactPascale Roux
Outcome results
None listed