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

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ClinicalTrials.gov Identifier: NCT03296150
Recruitment Status : Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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, evaluation of changes in patients' behaviors and economic evaluation.


Condition or disease Intervention/treatment
Cancer Oral Anticancer Drugs Behavioral: PRESTAGE

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Anticipated Study Start Date : October 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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"
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.


Outcome Measures

Primary Outcome Measures :
  1. Adherence evaluated by MicroElectronic Monitoring System [ Time Frame: at 4 months (after intervention or information) ]
    Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.


Secondary Outcome Measures :
  1. Adherence evaluated by Morisky questionnaires [ Time Frame: 4 months to 12 months ]
    Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.

  2. Adherence evaluated by pharmacy medication refill -based adherence [ Time Frame: 4 months to 12 months ]
    Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.

  3. Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire [ Time Frame: 4 months to 12 months ]
  4. Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire [ Time Frame: 4 months to 12 months ]
  5. Health-related quality of life evaluated by the EORTC quality of life questionnaire [ Time Frame: 4 months to 12 months ]
  6. Changes in patients' behaviors evaluated by questionnaires [ Time Frame: 4 months to 12 months ]
    Beliefs about Medication questionnaire and satisfaction with medication questionnaires

  7. Costs by micro-costing method [ Time Frame: 12 months ]
  8. planned and unplanned hospitalization rates [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 70 years,
  • For which oral anticancer therapy has been initiated within the previous 30 days or will be started within 30 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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296150


Contacts
Contact: Olivia LE SAUX olivia.lesaux@gmail.com
Contact: Claire FALANDRY, MD claire.falandry@chu-lyon.fr

Locations
France
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL Not yet recruiting
Bron, France, 69500
Contact: François DUCRAY, MD       francois.ducray@chu-lyon.fr   
Principal Investigator: François DUCRAY, MD         
Service de Gériatrie, Centre Hospitalier de Givors Not yet recruiting
Givors, France, 69700
Contact: Youri CHAULEUR, MD       ychauleur@ch-givors.fr   
Principal Investigator: Youri CHAULEUR, MD         
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole Not yet recruiting
La Tronche, France, 38700
Contact: Hervé CURE, MD       hcure@chu-grenoble.fr   
Principal Investigator: Hervé CURE, MD         
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL Not yet recruiting
Lyon, France, 69003
Contact: Elisabeth CASTEL-KREMER, MD       elisabeth.castel-kremer@chu-lyon.fr   
Principal Investigator: Elisabeth CASTEL-KREMER, MD         
Sub-Investigator: Catherine LOMBARD-BOHAS, MD         
Sub-Investigator: Thomas WALTER, MD         
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL Not yet recruiting
Lyon, France, 69004
Contact: Amandine BRUYAS, MD       amandine.bruyas@chu-lyon.fr   
Service d'oncologie médicale, Cnetre Léon Bérard Not yet recruiting
Lyon, France, 69373 cedex 08
Contact: Olivier TREDAN, MD       olivier.tredan@lyon.unicancer.fr   
Principal Investigator: Olivier TREDAN, MD         
Service d'oncologie, Centre Hospitalier Annecy Genevois Not yet recruiting
Metz-Tessy, France, 74370
Contact: Laëtitia STEFANI, MD       lstefani@ch-annecygenevois.fr   
Principal Investigator: Laëtitia STEFANI, MD         
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon) Not yet recruiting
Pierre-Bénite, France, 69310
Contact: Olivia LE SAUX       olivia.lesaux@gmail.com   
Contact: Claire FALANDRY, MD       claire.falandry@chu-lyon.fr   
Principal Investigator: Claire FALANDRY, MD         
Sub-Investigator: Benoît YOU, MD         
Sub-Investigator: Denis MAILLET, MD         
Sub-Investigator: Nathalie BONNIN, MD         
Sub-Investigator: Véronique TRILLET-LENOIR, MD         
Sub-Investigator: Salima HAMIZI, MD         
Sub-Investigator: Sophie TARTAS, MD         
Sub-Investigator: Julien PERON, MD         
Sub-Investigator: Gilles FREYER, MD         
Sub-Investigator: Stéphane DALLE, MD         
Sub-Investigator: Phelip GILDAS, MD         
Sub-Investigator: Pierre-Jean SOUQUET, MD         
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Saint-Étienne, France, 42100
Sponsors and Collaborators
Hospices Civils de Lyon
More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03296150     History of Changes
Other Study ID Numbers: 69HCL16_0149
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
therapeutic educational program
adherence
quality of life
elderly
cancer