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

NCT04832113 | Unknown

• 1 other identifier: ET20-0284 ETADAPT
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency

  An average of 4 months

• Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity

  An average of 4 months

• Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques

  An average of 4 months

• Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life

  An average of 4 months

• Evaluate the contribution of Patient's Therapeutic Education on the undernutrition

  An average of 4 months

Study Arms (2)

Patient Therapeutics Education (PTE)

EXPERIMENTAL

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

Conventional support

OTHER

Dietary and hydration advices

Other: conventional management

Interventions

Adapted Physical Activity and Dietetic OTHER

session in addtion conventional management dietetic, hydratation and physical activity

Also known as: Follow-up of Adapted Physical Activity and Dietetic Hydratation

Patient Therapeutics Education (PTE)

conventional management OTHER

Dietary and hydratation advices according to the recommendations

Also known as: conventional management dietary and hydratation

Conventional support

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (5)

Chu de saint etienne

Saint-Etienne, Rhône-Alpes Auvergne, 42000, France

NOT YET RECRUITING

Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD

Grenoble, 38028, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

NOT YET RECRUITING

Centre Eugène Marquis

Rennes, 35042, France

RECRUITING

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, 44805, France

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pascale Roux

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Séverine METZGER

CONTACT

+33478782786; severine.metzger@lyon.unicancer.fr

Pascale Roux

CONTACT

+33478787200; pascale.roux@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: April 5, 2021
• Study Start: June 21, 2021
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

FR (5)