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

Prostate Cancer Clinical Trial

— ETADAPT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832113
• Other study ID #: ET20-0284 ETADAPT
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Centre Leon Berard
• Contact: Séverine METZGER
• Phone: +33478782786
• Email: severine.metzger[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Adapted Physical Activity and Dietetic
session in addtion conventional management dietetic, hydratation and physical activity
• conventional management
Dietary and hydratation advices according to the recommendations

Locations

Country	Name	City	State
France	Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD	Grenoble
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre Eugène Marquis	Rennes
France	Chu de saint etienne	Saint-Étienne	Rhône-Alpes Auvergne
France	Institut de Cancérologie de l'Ouest René Gauducheau	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the contribution of Patient's Therapeutic Education on the undernutrition	Collection of patients' weight (kg)	An average of 4 months
Secondary	Evaluate the contribution of Patient's Therapeutic Education on the food intake	Collection of patients' weight (kg)	An average of 4 months
Secondary	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
Secondary	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
Secondary	Evaluate the contribution of Patient's Therapeutic Education on the undernutrition	Using the "Eating and hydration habits questionnaire"	An average of 4 months
Secondary	Evaluate the contribution of Patient's Therapeutic Education on the food intake	Using the "Eating and hydration habits questionnaire"	An average of 4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the compliance to APA session recommendations	Daily collection of steps numbers	An average of 4 months
Secondary	Evaluate the compliance to APA session recommendations	Evaluation during phone calls every 15 days	An average of 4 months
Secondary	Evaluate the number of patients requiring additional dietetic session	Evaluation during phone calls every 15 days	An average of 4 months
Secondary	Evaluate the number of patients requiring additional APA session	Evaluation during phone calls every 15 days	An average of 4 months