Back to resultsOptimization of the Patient Care Pathway in Immuno-oncology (OPTIMMUNO)
Primary Purpose
Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dedicated and coordinated e-follow-up during the treatment period
Standard follow-up during the treatment period
Sponsored by
About this trial
This is an interventional health services research trial for Melanoma focused on measuring Advanced melanoma, Immune checkpoint, E-follow-up
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hôpital Saint André, CHU de Bordeaux
- Institut claudius regaud IUCT ONCOPOLE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental
Standard
Arm Description
Outcomes
Primary Outcome Measures
Average length of administrative stay in the hospital
Secondary Outcome Measures
Number of cancelled or delayed hospital stay
Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Treatment response rate at 3 months
Correlation between the day hospital stay and the patient general health
Frequency of web interface completion (Experimental arm only)
Patient satisfaction to the e-follow-up (Experimental arm only)
Rate of reclassified alerts after intervention of nurse (Experimental arm only)
Full Information
NCT ID
NCT03329755
First Posted
October 25, 2017
Last Updated
February 23, 2021
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT03329755
Brief Title
Optimization of the Patient Care Pathway in Immuno-oncology
Acronym
OPTIMMUNO
Official Title
Optimization of the Patient Care Pathway in Immuno-oncology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 26, 2017 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Advanced melanoma, Immune checkpoint, E-follow-up
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Standard
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Dedicated and coordinated e-follow-up during the treatment period
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Standard follow-up during the treatment period
Intervention Description
- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)
Primary Outcome Measure Information:
Title
Average length of administrative stay in the hospital
Time Frame
3 months by patient
Secondary Outcome Measure Information:
Title
Number of cancelled or delayed hospital stay
Time Frame
3 months by patient
Title
Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Time Frame
3 months by patient
Title
Treatment response rate at 3 months
Time Frame
3 months by patient
Title
Correlation between the day hospital stay and the patient general health
Time Frame
3 months by patient
Title
Frequency of web interface completion (Experimental arm only)
Time Frame
3 months by patient
Title
Patient satisfaction to the e-follow-up (Experimental arm only)
Time Frame
3 months by patient
Title
Rate of reclassified alerts after intervention of nurse (Experimental arm only)
Time Frame
3 months by patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Hôpital Saint André, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut claudius regaud IUCT ONCOPOLE
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Optimization of the Patient Care Pathway in Immuno-oncology
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