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

February 23, 2021 updated by: Institut Claudius Regaud

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months by patient
3 months by patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of cancelled or delayed hospital stay
Time Frame: 3 months by patient
3 months by patient
Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Time Frame: 3 months by patient
3 months by patient
Treatment response rate at 3 months
Time Frame: 3 months by patient
3 months by patient
Correlation between the day hospital stay and the patient general health
Time Frame: 3 months by patient
3 months by patient
Frequency of web interface completion (Experimental arm only)
Time Frame: 3 months by patient
3 months by patient
Patient satisfaction to the e-follow-up (Experimental arm only)
Time Frame: 3 months by patient
3 months by patient
Rate of reclassified alerts after intervention of nurse (Experimental arm only)
Time Frame: 3 months by patient
3 months by patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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