Actively Recruiting
ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
Led by Hospices Civils de Lyon · Updated on 2024-05-03
139
Participants Needed
9
Research Sites
413 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 70 years
- Oral anticancer therapy started within the previous 45 days or planned within 45 days
- Any type of cancer, solid or hematologic, any stage
- Estimated life expectancy greater than 6 months
- Affiliated to social security or equivalent
- Able to answer questionnaires and protocol evaluations
- Signed informed consent
- Living within 50 km of the investigating center
You will not qualify if you...
- Breast cancer patients receiving only hormone therapy
- Prostate cancer patients on first-generation hormone therapy
- Unavailable for regular follow-up due to geographic, family, social, or psychological reasons
- Serious physical or mental condition causing permanent disability preventing treatment
- Patient deprived of liberty or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
Bron, France, 69500
Actively Recruiting
2
Service de Gériatrie, Centre Hospitalier de Givors
Givors, France, 69700
Withdrawn
3
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
La Tronche, France, 38700
Withdrawn
4
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
Lyon, France, 69003
Actively Recruiting
5
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
Lyon, France, 69004
Actively Recruiting
6
Service d'oncologie médicale, Cnetre Léon Bérard
Lyon, France, 69373 cedex 08
Not Yet Recruiting
7
Service d'oncologie, Centre Hospitalier Annecy Genevois
Metz-Tessy, France, 74370
Not Yet Recruiting
8
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, France, 69310
Actively Recruiting
9
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Saint-Etienne, France, 42100
Withdrawn
Research Team
O
Olivia LE SAUX
CONTACT
C
Claire FALANDRY, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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