Chemotherapy EffectMelodiaNCT05350930
Multidisciplinary Care Program to Secure MEdication Therapy for HematoLOgy Patients Receiving Injectable Anticancer Drugs
An observational study of Chemotherapy Effect and G-CHOP Chemotherapy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Effect, G-CHOP Chemotherapy, R-CHOP Chemotherapy
- What is being tested?
- Assessment of patient satisfaction regarding tele-consultation, Literacy questionnaire and Collection of socio-demographic characteristics
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2022to 15 Feb 2023
- Phase
- Observational
- 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
Study population: 150 patients treated in the hematology department of a university hospital
Who may be able to join
- Adult patients aged 18 years or older With hematological malignancy at any stage Initiating R-CHOP or G-CHOP chemotherapy Who do not object to participation in the study and use of collected data
Who cannot join
- Patients already enrolled in a clinical trial evaluating any drug product
- Patients living in an institution
- Patients protected by law
- Adults subject to a legal protection measure (curatorship, guardianship) (article L1121-8 of the CSP)
- Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social establishment (article L1121-6 of the CSP)
Trial locations and contacts
1 site in 1 country.
About this study
Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations.
This study aims to evaluate the impact of a multidisciplinary city-hospital follow-up program on medication management safety in haematological oncology patients receiving intravenous chemotherapy in onco-haematology. Additional aspects will be evaluated, such as the impact of the follow-up on the city-hospital link, satisfaction of patients and professionals involved in the follow-up and the use of telecare
- Being tested
- Assessment of patient satisfaction regarding tele-consultation, Literacy questionnaire, Collection of socio-demographic characteristics, Assessment of patient knowledge on chemotherapy side effects and support medications, Assessment of patient satisfaction on pharmaceutical follow-up
- Keywords
- Haematology, Pharmaceutical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of patient satisfaction regarding tele-consultationOther
Questionnaire completed following the teleconsultation, if applicable.
Literacy questionnaireOther
Questionnaire completed during hospitalization for the first chemotherapy cycle
Collection of socio-demographic characteristicsOther
Questionnaire completed during patient hospitalization for the first chemotherapy cycle
Assessment of patient knowledge on chemotherapy side effects and support medicationsOther
Questionnaire completed during patient hospitalization for the first, second and sixth cycle of chemotherapy
Assessment of patient satisfaction on pharmaceutical follow-upOther
Questionnaire completed during patient hospitalization for the sixth chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP or G-CHOP chemotherapy | Patients with hematological malignancies receiving R-CHOP or G-CHOP chemotherapy Receives: Other: Assessment of patient satisfaction regarding tele-consultation; Other: Literacy questionnaire; Other: Collection of socio-demographic characteristics; Other: Assessment of patient knowledge on chemotherapy side effects and support medications; Other: Assessment of patient satisfaction on pharmaceutical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical impact of pharmacist interventions at first cycle of chemotherapy, according to the CLEO© scale.
Each pharmacist intervention performed during patient follow-up will be rated according to its expected level of clinic impact (major, moderate, minor, null)
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start9 Jun 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350930
- Sponsor's protocol ID
- 69HCL22_0292
- Acronym
- Melodia
- Status last verified
- Mar 2025
- First submitted
- 22 Apr 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Care Program to Secure MEdication Therapy for HematoLOgy Patients Receiving Injectable Anticancer Drugs
- ClinicalTrials.gov ID
- NCT05350930
- Acronym / sponsor ID
- Melodia / 69HCL22_0292
- Keywords
- Haematology, Pharmaceutical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- 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.
Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations.
This study aims to evaluate the impact of a multidisciplinary city-hospital follow-up program on medication management safety in haematological oncology patients receiving intravenous chemotherapy in onco-haematology. Additional aspects will be evaluated, such as the impact of the follow-up on the city-hospital link, satisfaction of patients and professionals involved in the follow-up and the use of telecare
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CHOP or G-CHOP chemotherapy | – | Other: Assessment of patient satisfaction regarding tele-consultation, Other: Literacy questionnaire, Other: Collection of socio-demographic characteristics, Other: Assessment of patient knowledge on chemotherapy side effects and support medications, Other: Assessment of patient satisfaction on pharmaceutical follow-upPatients with hematological malignancies receiving R-CHOP or G-CHOP chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients treated in the hematology department of a university hospital
Key inclusion criteria (1 listed)
- Adult patients aged 18 years or older With hematological malignancy at any stage Initiating R-CHOP or G-CHOP chemotherapy Who do not object to participation in the study and use of collected data
Key exclusion criteria (5 listed)
- Patients already enrolled in a clinical trial evaluating any drug product
- Patients living in an institution
- Patients protected by law
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 |
|---|---|---|
| Assessment of patient satisfaction regarding tele-consultationQuestionnaire completed following the teleconsultation, if applicable. | Other | R-CHOP or G-CHOP chemotherapy |
| Literacy questionnaireQuestionnaire completed during hospitalization for the first chemotherapy cycle | Other | R-CHOP or G-CHOP chemotherapy |
| Collection of socio-demographic characteristicsQuestionnaire completed during patient hospitalization for the first chemotherapy cycle | Other | R-CHOP or G-CHOP chemotherapy |
| Assessment of patient knowledge on chemotherapy side effects and support medicationsQuestionnaire completed during patient hospitalization for the first, second and sixth cycle of chemotherapy | Other | R-CHOP or G-CHOP chemotherapy |
| Assessment of patient satisfaction on pharmaceutical follow-upQuestionnaire completed during patient hospitalization for the sixth chemotherapy cycle | Other | R-CHOP or G-CHOP chemotherapy |
Primary outcome
Evaluation of the clinical impact of pharmacist interventions at first cycle of chemotherapy, according to the CLEO© scale.
Time frame: 6 months after inclusion
Each pharmacist intervention performed during patient follow-up will be rated according to its expected level of clinic impact (major, moderate, minor, null)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy Effect and G-CHOP Chemotherapy, run by Hospices Civils de Lyon at 1 site 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the clinical impact of pharmacist interventions at first cycle of chemotherapy, according to the CLEO© scale. (time frame: 6 months after inclusion). 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 7 Mar 2025.