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

All adult patients with cancer, treated with oral anticancer drugs and benefiting of the ONCORAL program at the Lyon-Sud hospital

Patients will benefit of supervision by the ONCORAL team in the usual way and their intervention will be limited to completing questionnaires.

Questionnaires

Catherine RIOUFOL, Pr

Anne-Gaëlle CAFFIN, Dr

Florence RANCHON, MCU-PH

Marie-Anne CERFON, PH

With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care.

Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities.

The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care.

The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality).

This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology.

PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments

Value of RDI (Relative-Dose-Intensity) is the ratio between the dose prescribed to the patient versus the maximum reference dose recommended by the product characteristics summary of the drug.

This ratio is expressed as a percentage (%).

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Patients treated with oral anticancer drugs followed in the Oncoral program

One directive interview conducted by telephone

Directive Interview

The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus.

Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.

This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.

Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients

Assessment of the Impact of the COVID-19 Pandemic on Drug Use and on the Perception of Remote Monitoring by Cancer Patients Followed in the ONCORAL Program

Percentage of patients reporting a change in medication use and / or a change medication management and / or a change in oral anticancer drug adherence during the COVID-19 pandemic-related containment period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE	NCT03296150	Cancer Oral Anticancer...	PRESTAGE	70 Years -	Hospices Civils de Lyon
PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments	NCT06317389	Cancer Oncology Oncoral Program	Questionnaires	18 Years -	Hospices Civils de Lyon
PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments	NCT06317389	Cancer Oncology Oncoral Program	Questionnaires	18 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
Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients	NCT05069662	Cancer	Directive Inter...	18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for oral anticancer drugs