Spots Global Cancer Trial Database for ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
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Trial Identification
Brief Title: ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
Official Title: 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
Study ID: NCT03296150
Interventions
Study Description
Brief Summary: As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized. PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being. ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.
Detailed Description:
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL, Bron, , France
Service de Gériatrie, Centre Hospitalier de Givors, Givors, , France
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole, La Tronche, , France
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL, Lyon, , France
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL, Lyon, , France
Service d'oncologie médicale, Cnetre Léon Bérard, Lyon, , France
Service d'oncologie, Centre Hospitalier Annecy Genevois, Metz-Tessy, , France
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon), Pierre-Bénite, , France
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne, Saint-Étienne, , France
Contact Details
Name: Olivia LE SAUX
Affiliation: Hospices Civils de Lyon
Role: STUDY_CHAIR
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