Clinical trial NCT03296150: ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Oral Anticancer Drugs
Keywords: therapeutic educational program
adherence
quality of life
elderly
cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 139
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence evaluated by MicroElectronic Monitoring System
timeFrame: at 4 months (after intervention or information)
Secondary outcomes:
measure: Adherence evaluated by Morisky questionnaires
timeFrame: 4 months to 12 months
measure: Adherence evaluated by pharmacy medication refill -based adherence
timeFrame: 4 months to 12 months
measure: Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire
timeFrame: 4 months to 12 months
measure: Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire
timeFrame: 4 months to 12 months
measure: Health-related quality of life evaluated by the EORTC quality of life questionnaire
timeFrame: 4 months to 12 months
measure: Changes in patients' behaviors evaluated by questionnaires
timeFrame: 4 months to 12 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
city: Givors
country: France
facility: Service de Gériatrie, Centre Hospitalier de Givors
city: La Tronche
country: France
facility: Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
city: Lyon
country: France
facility: Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
city: Lyon
country: France
facility: Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
city: Lyon
country: France
facility: Service d'oncologie médicale, Cnetre Léon Bérard
city: Metz-Tessy
country: France
facility: Service d'oncologie, Centre Hospitalier Annecy Genevois
city: Pierre-Bénite
country: France
facility: Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
city: Saint-Étienne
country: France
facility: service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Olivia LE SAUX
role: STUDY_CHAIR
References: