MelanomaOPTIMMUNONCT03329755
Optimization of the Patient Care Pathway in Immuno-oncology
A study testing Dedicated and coordinated e-follow-up during the treatment period and Standard follow-up during the treatment period in people with Melanoma, run by Institut Claudius Regaud at 2 sites in France.
Trial summary
This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Dedicated and coordinated e-follow-up during the treatment period and Standard follow-up during the treatment period
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Dec 2017to 19 Feb 2021
- 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 with advanced (unresectable melanoma (stage III)) or metastatic (stage IV) melanoma and starting an Immune Checkpoint Inhibitor treatment (Monotherapy or Combination Therapy)
- Patient starting first cycle of Immune Checkpoint Inhibitor treatment in an ambulatory care structure
- Treatment which can be delayed for 7 days or more
- Age > or = 18 years old
- Patient with a phone and/or computer equipment
- Patient affiliated to the french social security system
- Patient must provide written informed consent prior to any study-specific procedure or assessment
Who cannot join
- Patient with diagnosis other than advanced melanoma
- Patient who must receive a treatment other than Immune Checkpoint Inhibitor
- Treatment administered during a conventional hospital stay (period of more than 24 hours)
- Patient with no caregiver
- Pregnant or breastfeeding women
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient protected by law
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Saint André, CHU de Bordeaux
Bordeaux, 33076
Institut claudius regaud IUCT ONCOPOLE
Toulouse, 31059
About this study
This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients.
This protocol will be based on two different follow-up during the treatment period:
- dedicated and coordinated e-follow-up (IUCT-O in Toulouse)
- standard follow-up (University Hospital Center in Bordeaux)
Patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.
- Conditions
- Melanoma
- Being tested
- Dedicated and coordinated e-follow-up during the treatment period, Standard follow-up during the treatment period
- Keywords
- Advanced melanoma, Immune checkpoint, E-follow-up
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated and coordinated e-follow-up during the treatment periodOther
- Completion of questionnaires using an electronic tool
- Telephone follow-up between the nurse and the patient
- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)
Standard follow-up during the treatment periodOther
- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Dedicated and coordinated e-follow-up during the treatment period |
| Standard | Other | Not described Receives: Other: Standard follow-up during the treatment period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average length of administrative stay in the hospital
Measured: 3 months by patient
Secondary outcomes (7)
Number of cancelled or delayed hospital stay
Measured: 3 months by patient
Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Measured: 3 months by patient
Treatment response rate at 3 months
Measured: 3 months by patient
Correlation between the day hospital stay and the patient general health
Measured: 3 months by patient
Frequency of web interface completion (Experimental arm only)
Measured: 3 months by patient
Patient satisfaction to the e-follow-up (Experimental arm only)
Measured: 3 months by patient
Rate of reclassified alerts after intervention of nurse (Experimental arm only)
Measured: 3 months by patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start26 Dec 2017
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329755
- Sponsor's protocol ID
- 16 CUTA 05
- Acronym
- OPTIMMUNO
- Status last verified
- Feb 2021
- First submitted
- 25 Oct 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Patient Care Pathway in Immuno-oncology
- ClinicalTrials.gov ID
- NCT03329755
- Acronym / sponsor ID
- OPTIMMUNO / 16 CUTA 05
- Conditions
- Melanoma
- Keywords
- Advanced melanoma, Immune checkpoint, E-follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 6 Nov 2017 (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.
This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients.
This protocol will be based on two different follow-up during the treatment period:
- dedicated and coordinated e-follow-up (IUCT-O in Toulouse)
- standard follow-up (University Hospital Center in Bordeaux)
Patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Dedicated and coordinated e-follow-up during the treatment period |
| Standard | Other | Other: Standard follow-up during the treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with advanced (unresectable melanoma (stage III)) or metastatic (stage IV) melanoma and starting an Immune Checkpoint Inhibitor treatment (Monotherapy or Combination Therapy)
- Patient starting first cycle of Immune Checkpoint Inhibitor treatment in an ambulatory care structure
- Treatment which can be delayed for 7 days or more
- Age > or = 18 years old
- Patient with a phone and/or computer equipment
Key exclusion criteria (7 listed)
- Patient with diagnosis other than advanced melanoma
- Patient who must receive a treatment other than Immune Checkpoint Inhibitor
- Treatment administered during a conventional hospital stay (period of more than 24 hours)
- Patient with no caregiver
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Dedicated and coordinated e-follow-up during the treatment period* Completion of questionnaires using an electronic tool * Telephone follow-up between the nurse and the patient * Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) | Other | Experimental |
| Standard follow-up during the treatment period- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) | Other | Standard |
Primary outcome
Average length of administrative stay in the hospital
Time frame: 3 months by patient
7 secondary outcomes
Number of cancelled or delayed hospital stay
Time frame: 3 months by patient
Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Time frame: 3 months by patient
Treatment response rate at 3 months
Time frame: 3 months by patient
Correlation between the day hospital stay and the patient general health
Time frame: 3 months by patient
Frequency of web interface completion (Experimental arm only)
Time frame: 3 months by patient
Patient satisfaction to the e-follow-up (Experimental arm only)
Time frame: 3 months by patient
Rate of reclassified alerts after intervention of nurse (Experimental arm only)
Time frame: 3 months by patient
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 24 Feb 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dedicated and coordinated e-follow-up during the treatment period and Standard follow-up during the treatment period in people with Melanoma, run by Institut Claudius Regaud at 2 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 7 inclusion and 7 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Average length of administrative stay in the hospital (time frame: 3 months by patient). 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 24 Feb 2021.