Optimization of the Patient Care Pathway in Immuno-oncology (OPTIMMUNO)

Institut Claudius Regaud

Status: Completed

Conditions: Melanoma

Treatments: Other: Standard follow-up during the treatment period; Other: Dedicated and coordinated e-follow-up during the treatment period

Study type: Interventional

Funder types: Other

Identifiers

NCT03329755

16 CUTA 05

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Experimental

Experimental group

Treatment:

Other: Dedicated and coordinated e-follow-up during the treatment period

Standard

Other group

Treatment:

Other: Standard follow-up during the treatment period