NeoplasmCHIMIO ORALENCT02828449
Assesment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
A study testing therapeutic education program in people with Neoplasm, run by Institut de Cancérologie de la Loire at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- therapeutic education program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69008
David PEROL, MD
- Recruiting
CH Lyon Sud
Pierre-Bénite, 69310
Claire Falandry, PhDMD
- Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Cécile Vassal, MD
About this study
Official title: Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
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:
- Assess the achievement of the target population
- Evaluate the adaptation of intervention in context
- 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.
- Assessing the sustainability of the intervention
- Conditions
- Neoplasm
- Being tested
- therapeutic education program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic education programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: therapeutic education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of affected population
Measured: 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.
Measured: 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.
Measured: 3 months
Quality of Life Questionnaire
Measured: 3 months
Morisky Measurement Adherence Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon, Centre Leon Berard
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828449
- Sponsor's protocol ID
- 2014-12
- Acronym
- CHIMIO ORALE
- Status last verified
- Sep 2017
- First submitted
- 25 Feb 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
- ClinicalTrials.gov ID
- NCT02828449
- Acronym / sponsor ID
- CHIMIO ORALE / 2014-12
- Conditions
- Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon, Centre Leon Berard
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the achievement of the target population
- Evaluate the adaptation of intervention in context
- 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.
- Assessing the sustainability of the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapeutic education program | Experimental | Behavioral: therapeutic education programtherapeutic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic education program | Behavioural | therapeutic education program |
Primary outcome
percentage of affected population
Time frame: 3 months
Level of acquisition of knowledge
Time frame: 3 months
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.
Anxiety and Depression
Time frame: 3 months
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.
Quality of Life Questionnaire
Time frame: 3 months
Morisky Measurement Adherence Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic education program in people with Neoplasm, run by Institut de Cancérologie de la Loire at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie BOURMAUD, MD (04 77 91 74 77, aurelie.bourmaud@icloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of affected population (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.