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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Adapted Physical Activity and Dietetic; Other: conventional management

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.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Séverine METZGER; Phone Number: +33478782786; Email: severine.metzger@lyon.unicancer.fr
• Study Contact Backup: Name: Pascale Roux; Phone Number: +33478787200; Email: pascale.roux@lyon.unicancer.fr

Study Locations

• France
  • Grenoble, France, 38028
    • Recruiting
    • Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard
    • Contact: Olivia DIAZ, MD; Email: o-diaz@ghm-grenoble.fr
  • Pierre-Bénite, France, 69495
    • Not yet recruiting
    • Centre Hospitalier Lyon Sud
    • Contact: Samy HORN, MD; Email: samy.horn@chu-lyon.fr
  • Rennes, France, 35042
    • Recruiting
    • Centre Eugene Marquis
    • Contact: Manon BATY, MD; Email: m.baty@rennes.unicancer.fr
  • Saint-Herblain, France, 44805
    • Not yet recruiting
    • Institut de Cancerologie de L'Ouest Rene Gauducheau
    • Contact: Stéphane SUPIOT, MD; Email: stephane.supiot@ico.unicancer.fr
  • Rhône-Alpes Auvergne
    • Saint-Étienne, Rhône-Alpes Auvergne, France, 42000
      • Not yet recruiting
      • CHU de Saint Etienne
      • Contact: Thomas REYNAUD, MD
      • Contact: Email: Thomas.Reynaud@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Therapeutics Education (PTE); Educational diagnosis prior radiotherapy and participation to Patient Therapeutics Education (PTE) in Adapted Physical Activity (APA) and dietetic sessions. In addition to conventional support (dietary and hydration advice).	Other: Adapted Physical Activity and Dietetic; session in addtion conventional management dietetic, hydratation and physical activity; Other Names: Follow-up of Adapted Physical Activity and Dietetic Hydratation
Other: Conventional support; Dietary and hydration advices	Other: conventional management; Dietary and hydratation advices according to the recommendations; Other Names: conventional management dietary and hydratation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Pascale Roux, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: ET20-0284 ETADAPT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No