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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Other: Dedicated and coordinated e-follow-up during the treatment period; Other: Standard follow-up during the treatment period

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Hôpital Saint André, CHU de Bordeaux
  • Toulouse, France, 31059
    • Institut Claudius regaud IUCT Oncopole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Other: Dedicated 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)
Other: Standard	Other: Standard follow-up during the treatment period; - Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Actual): February 19, 2021
• Study Completion (Actual): February 19, 2021

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Advanced melanoma; Immune checkpoint; E-follow-up
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 16 CUTA 05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No