NCT03296150

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

7.9 years

First QC Date

September 23, 2017

Last Update Submit

May 2, 2024

Conditions

CancerOral Anticancer Drugs

Keywords

therapeutic educational programadherencequality of lifeelderlycancer

Outcome Measures

Primary Outcomes (1)

  • Adherence evaluated by MicroElectronic Monitoring System

    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 Outcomes (6)

  • Adherence evaluated by Morisky questionnaires

    4 months to 12 months

  • Adherence evaluated by pharmacy medication refill -based adherence

    4 months to 12 months

  • Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire

    4 months to 12 months

  • Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire

    4 months to 12 months

  • Health-related quality of life evaluated by the EORTC quality of life questionnaire

    4 months to 12 months

  • +1 more secondary outcomes

Study Arms (2)

Control arm : Information

NO INTERVENTION

Patients will receive the usual standard information delivered to patients

Intervention arm : Therapeutic educational program

EXPERIMENTAL

Patients will receive the therapeutic educational program "PRESTAGE"

Behavioral: PRESTAGE

Interventions

PRESTAGEBEHAVIORAL

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.

Intervention arm : Therapeutic educational program

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL

Bron, 69500, France

RECRUITING

Service de Gériatrie, Centre Hospitalier de Givors

Givors, 69700, France

WITHDRAWN

Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole

La Tronche, 38700, France

WITHDRAWN

Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL

Lyon, 69003, France

RECRUITING

Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL

Lyon, 69004, France

RECRUITING

Service d'oncologie médicale, Cnetre Léon Bérard

Lyon, 69373 cedex 08, France

NOT YET RECRUITING

Service d'oncologie, Centre Hospitalier Annecy Genevois

Metz-Tessy, 74370, France

NOT YET RECRUITING

Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

Pierre-Bénite, 69310, France

RECRUITING

service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne

Saint-Etienne, 42100, France

WITHDRAWN

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Olivia LE SAUX

    Hospices Civils de Lyon

    STUDY CHAIR

Central Study Contacts

Olivia LE SAUX

CONTACT

04 78 86 37 75olivia.lesaux@gmail.com

Claire FALANDRY, MD

CONTACT

04 78 86 15 80claire.falandry@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2017

First Posted

September 28, 2017

Study Start

March 29, 2018

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)