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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
139
PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
Bron, France
RECRUITINGService de Gériatrie, Centre Hospitalier de Givors
Givors, France
WITHDRAWNService d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
La Tronche, France
WITHDRAWNService de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
Lyon, France
RECRUITINGService de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
Lyon, France
RECRUITINGService d'oncologie médicale, Cnetre Léon Bérard
Lyon, France
NOT_YET_RECRUITINGService d'oncologie, Centre Hospitalier Annecy Genevois
Metz-Tessy, France
NOT_YET_RECRUITINGService de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, France
RECRUITINGservice de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Saint-Etienne, France
WITHDRAWNAdherence evaluated by MicroElectronic Monitoring System
Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.
Time frame: at 4 months (after intervention or information)
Adherence evaluated by Morisky questionnaires
Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.
Time frame: 4 months to 12 months
Adherence evaluated by pharmacy medication refill -based adherence
Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.
Time frame: 4 months to 12 months
Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire
Time frame: 4 months to 12 months
Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire
Time frame: 4 months to 12 months
Health-related quality of life evaluated by the EORTC quality of life questionnaire
Time frame: 4 months to 12 months
Changes in patients' behaviors evaluated by questionnaires
Beliefs about Medication questionnaire and satisfaction with medication questionnaires
Time frame: 4 months to 12 months
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