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

May 2, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Withdrawn
        • Service de Gériatrie, Centre Hospitalier de Givors
      • La Tronche, France, 38700
        • Withdrawn
        • Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
      • 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
        • Not yet recruiting
        • Service d'oncologie médicale, Cnetre Léon Bérard
        • Contact:
        • Principal Investigator:
          • Olivier TREDAN, MD
      • Metz-Tessy, France, 74370
        • Not yet 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
        • Withdrawn
        • service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings