Clinical trial NCT04832113: Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 216
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum
timeFrame: An average of 4 months
Secondary outcomes:
measure: Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the food intake
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the food intake
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the food intake
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits
timeFrame: An average of 4 months
measure: Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits
timeFrame: An average of 4 months
measure: Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm)
timeFrame: An average of 4 months
measure: Evaluate the compliance to APA session recommendations
timeFrame: An average of 4 months
measure: Evaluate the compliance to APA session recommendations
timeFrame: An average of 4 months
measure: Evaluate the number of patients requiring additional dietetic session
timeFrame: An average of 4 months
measure: Evaluate the number of patients requiring additional APA session
timeFrame: An average of 4 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de saint etienne
state: Rhône-Alpes Auvergne
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest René Gauducheau
Study officials:
affiliation: Centre Leon Berard
name: Pascale Roux
role: PRINCIPAL_INVESTIGATOR
References: