NCT02828449

Brief Summary

Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions. The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year:

  1. 1.Assess the achievement of the target population
  2. 2.Evaluate the adaptation of intervention in context
  3. 3.Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention.
  4. 4.Assessing the sustainability of the intervention

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

3 active sites

Status
unknown

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

February 25, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

February 25, 2016

Last Update Submit

September 13, 2017

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (5)

  • percentage of affected population

    3 months

  • Level of acquisition of knowledge

    Questionnaire composed of numerous questions dealing with patient's knowledge about his/her disease, treatment and treatment's side effects . Answers are quoted in Yes/No and a global scoring is made with all answers. Final measure is a percentage of good answers.

    3 months

  • Anxiety and Depression

    measured with the Hospital Anxiety Depression Scale (Zigmond \& Snaith, 1983 ), wich gives separated results about the level of anxiety and of depression according to the level of scoring to a set of 14 questions. Questions are rated from 0-3, and the anxiety and depression subscale scores range from 0-21. The cutoff for each subscale is eight.

    3 months

  • Quality of Life Questionnaire

    3 months

  • Morisky Measurement Adherence Scale

    3 months

Study Arms (1)

therapeutic education program

EXPERIMENTAL

therapeutic education program which aims is to improve the adherence to the treatment and management of adverse effects of this treatment in patients taking an oral chemotherapy for active cancer

Behavioral: therapeutic education program

Interventions

therapeutic education programBEHAVIORAL
therapeutic education program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient care in medical oncology services of the Cancer Institute of Lucien Neuwirth, the Lyon-Sud hospital and the Centre Léon Bérard:
  • Age over 18 years
  • Introducing an active cancer (local extension, locoregional or metastatic)
  • Oral chemotherapy as monotherapy or in combination with other treatments, initiated or in progress

You may not qualify if:

  • Refusal to participate, protected adult patient under guardianship.
  • Patient disability to understand the course of the study, the Therapeutic education program, or failure to follow the educational sessions.
  • Patient with documented history of cognitive or psychiatric disorders.
  • Patient on adjuvant therapy or hormone therapy for prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

CH Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Aurélie BOURMAUD, MD

CONTACT

04 77 91 74 77aurelie.bourmaud@icloire.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

July 11, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)