Optimization of the Patient Care Pathway in Immuno-oncology

Melanoma Clinical Trial

— OPTIMMUNO  

Official title:

Optimization of the Patient Care Pathway in Immuno-oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329755
• Other study ID #: 16 CUTA 05
• Status: Completed
• Phase: N/A
• Start date: December 26, 2017
• Est. completion date: February 19, 2021

Study information

• Verified date: February 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

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)
• Standard follow-up during the treatment period
- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)

Locations

Country	Name	City	State
France	Hôpital Saint André, CHU de Bordeaux	Bordeaux
France	Institut claudius regaud IUCT ONCOPOLE	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

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