Evaluating the PRESTAGE educational program for elderly cancer patients
ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE
This study tests whether an educational program can help older cancer patients better understand their treatment and improve their quality of life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 9 sites (Bron and 8 other locations) |
| Trial ID | NCT03296150 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the PRESTAGE educational program designed for elderly patients undergoing oral anticancer treatments. The program includes six workshops led by a multidisciplinary team to enhance patients' understanding of their disease and treatment, improve adherence, and promote overall well-being. Participants will be randomly assigned to receive the educational intervention or standard care, and their outcomes will be monitored over time. The focus is on improving quality of life and treatment adherence among geriatric patients facing cancer.
Who should consider this trial
Good fit: Ideal candidates are patients over 70 years old who have recently started or will start oral anticancer therapy.
Not a fit: Patients with breast cancer receiving only hormone therapy or those with serious conditions that prevent proper treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve treatment adherence and quality of life for elderly cancer patients.
How similar studies have performed: Other studies have shown that educational interventions can improve adherence and outcomes in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 70 years, * For which oral anticancer therapy has been initiated within the previous 45 days or will be started within 45 days * For any type of cancer, solid or hematologic, any stage * Estimated life expectancy\> 6 months * Affiliation to social security or equivalent * Patients who can answer questionnaires and protocol evaluations * Informed consent signed by patients * Domiciled within 50 km around the investigating center Exclusion Criteria: * For patients with breast cancer, exclusive treatment with hormone therapy * First-generation Hormone Therapy in Prostate Cancer * Patient not available for regular follow-up whatever the cause (geographic, family, social, psychological) * Any serious condition, ie serious physical or mental, leading to a disability permanent and likely to prevent the proper course of treatment * Patient deprived of liberty or under guardianship
Where this trial is running
Bron and 8 other locations
- Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL — Bron, France (Recruiting)
- Service de Gériatrie, Centre Hospitalier de Givors — Givors, France (Withdrawn)
- Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole — La Tronche, France (Withdrawn)
- Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL — Lyon, France (Recruiting)
- Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL — Lyon, France (Recruiting)
- Service d'oncologie médicale, Cnetre Léon Bérard — Lyon, France (Not_yet_recruiting)
- Service d'oncologie, Centre Hospitalier Annecy Genevois — Metz-Tessy, France (Not_yet_recruiting)
- Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon) — Pierre-Bénite, France (Recruiting)
- service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne — Saint-Etienne, France (Withdrawn)
Study contacts
- Study coordinator: Olivia LE SAUX
- Email: olivia.lesaux@gmail.com
- Phone: 04 78 86 37 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.