Optimization of the Patient Care Pathway in Immuno-oncology

Study Overview
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Brief Summary
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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.

Official Title
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Optimization of the Patient Care Pathway in Immuno-oncology

Conditions
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Melanoma

Intervention / Treatment
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* Other: Dedicated and coordinated e-follow-up during the treatment period
* Other: Standard follow-up during the treatment period


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Other: Dedicated and coordinated e-follow-up during the treatment period<br>* 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)<br>|
| Other: Standard<br> | Other: Standard follow-up during the treatment period<br>* - Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average length of administrative stay in the hospital |  | 3 months by patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cancelled or delayed hospital stay |  | 3 months by patient | 
| Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30) |  | 3 months by patient | 
| Treatment response rate at 3 months |  | 3 months by patient | 
| Correlation between the day hospital stay and the patient general health |  | 3 months by patient | 
| Frequency of web interface completion (Experimental arm only) |  | 3 months by patient | 
| Patient satisfaction to the e-follow-up (Experimental arm only) |  | 3 months by patient | 
| Rate of reclassified alerts after intervention of nurse (Experimental arm only) |  | 3 months by patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced melanoma, Immune checkpoint, E-follow-up