Impact of patient education on radiotherapy for prostate cancer

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.

This study is testing if teaching prostate cancer patients about diet and exercise can help them have fewer problems during radiotherapy and improve their overall well-being compared to standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Centre Leon Berard (other)
• Locations: 5 sites (Saint-Étienne, Rhône-Alpes Auvergne and 4 other locations)
• Trial ID: NCT04832113 on ClinicalTrials.gov

What this trial studies

This study evaluates how Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) and diet can reduce the need for interventions related to rectal volume during radiotherapy sessions for prostate cancer. It aims to assess the effectiveness of PTE on repositioning during treatment, gastrointestinal toxicity, and overall quality of life. The study will compare outcomes between patients receiving PTE and those receiving conventional management, focusing on dietary habits and physical activity. Additionally, patient satisfaction and compliance with the PTE program will be measured.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with prostatic adenocarcinoma scheduled for radiotherapy.

Not a fit: Patients with chronic inflammatory intestinal diseases or those unable to comply with study follow-up may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved radiotherapy outcomes and quality of life for prostate cancer patients.

How similar studies have performed: Previous studies have indicated potential benefits of therapeutic education and physical activity in similar patient populations, suggesting this approach may be promising.

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.

Where this trial is running

Saint-Étienne, Rhône-Alpes Auvergne and 4 other locations

• Chu de saint etienne — Saint-Étienne, Rhône-Alpes Auvergne, France (NOT_YET_RECRUITING)
• Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD — Grenoble, France (RECRUITING)
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France (NOT_YET_RECRUITING)
• Centre Eugène Marquis — Rennes, France (RECRUITING)
• Institut de Cancérologie de l'Ouest René Gauducheau — Saint-Herblain, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Pascale Roux — Centre Leon Berard
• Study coordinator: Séverine METZGER

Conditions: Prostate Cancer