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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Oral Anticancer Drugs

Intervention / Treatment
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* Behavioral: PRESTAGE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm : Information<br>Patients will receive the usual standard information delivered to patients | |
| Experimental: Intervention arm : Therapeutic educational program<br>Patients will receive the therapeutic educational program PRESTAGE | Behavioral: PRESTAGE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic educational program, adherence, quality of life, elderly, cancer