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

  • STATUS
    Recruiting
  • End date
    Apr 23, 2023
  • participants needed
    216
  • sponsor
    Centre Leon Berard
Updated on 23 April 2022

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.

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.

Details
Condition Prostate Cancer
Treatment conventional management, Adapted Physical Activity and Dietetic
Clinical Study IdentifierNCT04832113
SponsorCentre Leon Berard
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
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