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

May 12, 2023 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
        • Contact:
        • Principal Investigator:
          • Francois Ducray, MD
      • Givors, France, 69700
        • Recruiting
        • Service de Gériatrie, Centre Hospitalier de Givors
        • Contact:
        • Principal Investigator:
          • Youri CHAULEUR, MD
      • La Tronche, France, 38700
        • Recruiting
        • Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
        • Contact:
        • Principal Investigator:
          • Hervé CURE, MD
      • Lyon, France, 69003
        • Recruiting
        • Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
        • Contact:
        • Sub-Investigator:
          • Catherine LOMBARD-BOHAS, MD
        • Principal Investigator:
          • Byeul-A KIM, MD
        • Principal Investigator:
          • Elisabeth CASTEL-KREMER, MD
        • Sub-Investigator:
          • Thomas WALTER, MD
      • Lyon, France, 69004
        • Recruiting
        • Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
        • Contact:
      • Lyon, France, 69373 cedex 08
        • Recruiting
        • Service d'oncologie médicale, Cnetre Léon Bérard
        • Contact:
        • Principal Investigator:
          • Olivier Trédan, MD
      • Metz-Tessy, France, 74370
        • Recruiting
        • Service d'oncologie, Centre Hospitalier Annecy Genevois
        • Contact:
        • Principal Investigator:
          • Laëtitia STEFANI, MD
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Salima HAMIZI, MD
        • Sub-Investigator:
          • Stéphane DALLE, MD
        • Sub-Investigator:
          • Phelip GILDAS, MD
        • Sub-Investigator:
          • Pierre-Jean SOUQUET, MD
        • Principal Investigator:
          • Claire FALANDRY, MD
        • Sub-Investigator:
          • Benoit YOU, MD
        • Sub-Investigator:
          • Denis MAILLET, MD
        • Sub-Investigator:
          • Nathalie BONNIN, MD
        • Sub-Investigator:
          • Véronique TRILLET-LENOIR, MD
        • Sub-Investigator:
          • Sophie TARTAS, MD
        • Sub-Investigator:
          • Julien PERON, MD
        • Sub-Investigator:
          • Gilles FREYER, MD
      • Saint-Étienne, France, 42100
        • Recruiting
        • service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
        • Contact:
          • Ana-Maria DASCALITA, MD
        • Contact:
          • a.maria.dascalita@chu-st-etienne.fr
        • Principal Investigator:
          • Ana-MAria DASCALITA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 4 months (after intervention or information)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Study Chair: Olivia LE SAUX, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2018

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

September 23, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL16_0149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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