Melanoma
Conditions
Keywords
Advanced melanoma, Immune checkpoint, E-follow-up
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.
Interventions
OTHERDedicated 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)
OTHERStandard follow-up during the treatment period
\- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)
Sponsors
Institut Claudius Regaud
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with advanced (unresectable melanoma (stage III)) or metastatic (stage IV) melanoma and starting an Immune Checkpoint Inhibitor treatment (Monotherapy or Combination Therapy) 2. Patient starting first cycle of Immune Checkpoint Inhibitor treatment in an ambulatory care structure 3. Treatment which can be delayed for 7 days or more 4. Age \> or = 18 years old 5. Patient with a phone and/or computer equipment 6. Patient affiliated to the french social security system 7. Patient must provide written informed consent prior to any study-specific procedure or assessment
Exclusion criteria
1. Patient with diagnosis other than advanced melanoma 2. Patient who must receive a treatment other than Immune Checkpoint Inhibitor 3. Treatment administered during a conventional hospital stay (period of more than 24 hours) 4. Patient with no caregiver 5. Pregnant or breastfeeding women 6. 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 7. Patient protected by law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average length of administrative stay in the hospital | 3 months by patient |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of cancelled or delayed hospital stay | 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 |
| Frequency of web interface completion (Experimental arm only) | 3 months by patient |
Countries
France
Outcome results
None listed