Neoplasms

Mouth and Tooth Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Mouth Neoplasms

Quality of Life

Oral Cancer

Lip and Oral Cavity Cancer

Patients will receive the usual standard information delivered to patients

Patients will receive the therapeutic educational program "PRESTAGE"

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.

PRESTAGE

Olivia LE SAUX

Claire FALANDRY, MD

François DUCRAY, MD

Byeul-A KIM, MD

Elisabeth CASTEL-KREMER, MD

Catherine LOMBARD-BOHAS, MD

Thomas WALTER, MD

Amandine BRUYAS, MD

Olivier TREDAN, MD

Laëtitia STEFANI, MD

Benoît YOU, MD

Denis MAILLET, MD

Nathalie BONNIN, MD

Véronique TRILLET-LENOIR, MD

Salima HAMIZI, MD

Sophie TARTAS, MD

Julien PERON, MD

Gilles FREYER, MD

Stéphane DALLE, MD

Phelip GILDAS, MD

Pierre-Jean SOUQUET, MD

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.

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

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

Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.

Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.

Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.

Beliefs about Medication questionnaire and satisfaction with medication questionnaires

Hospices Civils de Lyon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE	NCT03296150	Cancer Oral Anticancer...	PRESTAGE	70 Years -	Hospices Civils de Lyon
ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE	NCT03296150	Cancer Oral Anticancer...	PRESTAGE	70 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for prestage

Every month we try and update this database with for prestage cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prestage

Every month we try and update this database with for prestage cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prestage cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.