Clinical trial NCT03329755: Optimization of the Patient Care Pathway in Immuno-oncology
Official title: Optimization of the Patient Care Pathway in Immuno-oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Advanced melanoma
Immune checkpoint
E-follow-up
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average length of administrative stay in the hospital
timeFrame: 3 months by patient
Secondary outcomes:
measure: Number of cancelled or delayed hospital stay
timeFrame: 3 months by patient
measure: Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)
timeFrame: 3 months by patient
measure: Treatment response rate at 3 months
timeFrame: 3 months by patient
measure: Correlation between the day hospital stay and the patient general health
timeFrame: 3 months by patient
measure: Frequency of web interface completion (Experimental arm only)
timeFrame: 3 months by patient
measure: Patient satisfaction to the e-follow-up (Experimental arm only)
timeFrame: 3 months by patient
measure: Rate of reclassified alerts after intervention of nurse (Experimental arm only)
timeFrame: 3 months by patient
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint André, CHU de Bordeaux
city: Toulouse
country: France
facility: Institut claudius regaud IUCT ONCOPOLE
Study officials:
References: