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Assesment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy

Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02828449
Acronym
CHIMIO ORALE
Enrollment
600
Registered
2016-07-11
Start date
2016-11-30
Completion date
2018-03-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm

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. Assess the achievement of the target population 2. Evaluate the adaptation of intervention in context 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. Assessing the sustainability of the intervention

Interventions

Sponsors

Hospices Civils de Lyon
CollaboratorOTHER
Centre Leon Berard
CollaboratorOTHER
Institut de Cancérologie de la Loire
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
percentage of affected population3 months
Level of acquisition of knowledge3 monthsQuestionnaire 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.
Anxiety and Depression3 monthsmeasured 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.
Quality of Life Questionnaire3 months
Morisky Measurement Adherence Scale3 months

Countries

France

Contacts

Primary ContactAurélie BOURMAUD, MD
aurelie.bourmaud@icloire.fr04 77 91 74 77

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026