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ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
Study Purpose
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 Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Exclusion Criteria:
- - 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 guardianshipTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
No Intervention: Control arm : Information
Patients will receive the usual standard information delivered to patients
Experimental: Intervention arm : Therapeutic educational program
Patients will receive the therapeutic educational program "PRESTAGE"
Interventions
Behavioral: - 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
Bron, , 69500
Site Contact
François DUCRAY, MD
[email protected]
04 78 86 37 75
Status
Withdrawn
Address
Service de Gériatrie, Centre Hospitalier de Givors
Givors, , 69700
Site Contact
[email protected]
04 78 86 37 75
Status
Withdrawn
Address
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
La Tronche, , 38700
Site Contact
[email protected]
04 78 86 37 75
Status
Recruiting
Address
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
Lyon, , 69003
Site Contact
Byeul-A KIM, MD
[email protected]
04 78 86 37 75
Status
Recruiting
Address
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
Lyon, , 69004
Site Contact
Amandine BRUYAS, MD
[email protected]
04 78 86 37 75
Status
Not yet recruiting
Address
Service d'oncologie médicale, Cnetre Léon Bérard
Lyon, , 69373 cedex 08
Site Contact
Olivier TREDAN, MD
[email protected]
04 78 86 37 75
Status
Not yet recruiting
Address
Service d'oncologie, Centre Hospitalier Annecy Genevois
Metz-Tessy, , 74370
Site Contact
Laëtitia STEFANI, MD
[email protected]
04 78 86 37 75
Status
Recruiting
Address
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, , 69310
Site Contact
Olivia LE SAUX
[email protected]
04 78 86 37 75
Status
Withdrawn
Address
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Saint-Étienne, , 42100
Site Contact
[email protected]
04 78 86 37 75
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