ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention arm : Therapeutic educational program	PRESTAGE	Patients will receive the therapeutic educational program "PRESTAGE"

Primary Outcome Measures

Name	Time	Method
Adherence evaluated by MicroElectronic Monitoring System	at 4 months (after intervention or information)	Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire	4 months to 12 months
Adherence evaluated by Morisky questionnaires	4 months to 12 months	Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.
Adherence evaluated by pharmacy medication refill -based adherence	4 months to 12 months	Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.
Health-related quality of life evaluated by the EORTC 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
Changes in patients' behaviors evaluated by questionnaires	4 months to 12 months	Beliefs about Medication questionnaire and satisfaction with medication questionnaires

Locations (9): Service de Gériatrie, Centre Hospitalier de Givors
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Givors, France
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
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Bron, France
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
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La Tronche, France
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
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Lyon, France
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
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Pierre-Bénite, France
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
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Saint-Étienne, France
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
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Lyon, France
Service d'oncologie, Centre Hospitalier Annecy Genevois
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Metz-Tessy, France
Service d'oncologie médicale, Cnetre Léon Bérard
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Lyon, France