Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer
NCT04832113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2023-08-31
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.
Conditions
Interventions
- OTHER
-
Adapted Physical Activity and Dietetic
session in addtion conventional management dietetic, hydratation and physical activity
- OTHER
-
conventional management
Dietary and hydratation advices according to the recommendations
Sponsors & Collaborators
-
Centre Leon Berard
lead OTHER
Principal Investigators
-
Pascale Roux · Centre Leon Berard
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-21
- Primary Completion
- 2024-10-31
- Completion
- 2025-04-30
Countries
- France
Study Locations
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