Optimization of the Patient Care Pathway in Immuno-oncology

Not Applicable

Completed

• Conditions: Melanoma
• Interventions: Other: Dedicated and coordinated e-follow-up during the treatment period; Other: Standard follow-up during the treatment period

• Registration Number: NCT03329755
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Study Start: 2017-12-26
• Status Verified: 2021-02
• Primary Completion: 2021-02-19
• Study Completion: 2021-02-19
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Dedicated and coordinated e-follow-up during the treatment period	-
Standard	Standard follow-up during the treatment period	-

Primary Outcome Measures

Name	Time	Method
Average length of administrative stay in the hospital	3 months by patient

Secondary Outcome Measures

Name	Time	Method
Frequency of web interface completion (Experimental arm only)	3 months by patient
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
Rate of reclassified alerts after intervention of nurse (Experimental arm only)	3 months by patient
Correlation between the day hospital stay and the patient general health	3 months by patient
Treatment response rate at 3 months	3 months by patient
Patient satisfaction to the e-follow-up (Experimental arm only)	3 months by patient

Trial Locations

Locations (2)

Hôpital Saint André, CHU de Bordeaux; 🇫🇷 Bordeaux, France

Institut claudius regaud IUCT ONCOPOLE; 🇫🇷 Toulouse, France