Optimization of the Patient Care Pathway in Immuno-oncology

NCT ID: NCT03329755

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-26
• Study Completion Date: 2021-02-19

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.

Conditions

Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

• 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

Group Type: OTHER

Standard follow-up during the treatment period

Intervention Type: OTHER

\- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)

Interventions

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)

Intervention Type: OTHER

Standard follow-up during the treatment period

\- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Saint André, CHU de Bordeaux

Bordeaux, , France

Institut claudius regaud IUCT ONCOPOLE

Toulouse, , France

Countries

France

Other Identifiers

16 CUTA 05

Identifier Type: -

Identifier Source: org_study_id