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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm : Information | No Intervention | Patients will receive the usual standard information delivered to patients | |
| Intervention arm : Therapeutic educational program | Experimental | Patients will receive the therapeutic educational program "PRESTAGE" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRESTAGE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence 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. | at 4 months (after intervention or information) |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence evaluated by Morisky questionnaires | Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months. | 4 months to 12 months |
| Adherence evaluated by pharmacy medication refill -based adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia LE SAUX | Contact | 04 78 86 37 75 | +33 | olivia.lesaux@gmail.com |
| Claire FALANDRY, MD | Contact | 04 78 86 15 80 | +33 | claire.falandry@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivia LE SAUX | Hospices Civils de Lyon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL | Recruiting | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.
| 4 months to 12 months |
| Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire | 4 months to 12 months |
| Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire | 4 months to 12 months |
| Health-related quality of life evaluated by the EORTC quality of life questionnaire | 4 months to 12 months |
| Changes in patients' behaviors evaluated by questionnaires | Beliefs about Medication questionnaire and satisfaction with medication questionnaires | 4 months to 12 months |
| Service de Gériatrie, Centre Hospitalier de Givors | Withdrawn | Givors | 69700 | France |
| Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole | Withdrawn | La Tronche | 38700 | France |
| Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL | Recruiting | Lyon | 69003 | France |
|
| Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL | Recruiting | Lyon | 69004 | France |
|
| Service d'oncologie médicale, Cnetre Léon Bérard | Not yet recruiting | Lyon | 69373 cedex 08 | France |
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| Service d'oncologie, Centre Hospitalier Annecy Genevois | Not yet recruiting | Metz-Tessy | 74370 | France |
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| Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon) | Recruiting | Pierre-Bénite | 69310 | France |
|
| service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne | Withdrawn | Saint-Etienne | 42100 | France |