NCT03329755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 26, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

October 25, 2017

Last Update Submit

February 23, 2021

Conditions

Melanoma

Keywords

Advanced melanomaImmune checkpointE-follow-up

Outcome Measures

Primary Outcomes (1)

  • Average length of administrative stay in the hospital

    3 months by patient

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL
Other: Dedicated and coordinated e-follow-up during the treatment period

Standard

OTHER
Other: Standard follow-up during the treatment period

Interventions

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

* 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)

Experimental
Standard follow-up during the treatment periodOTHER

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

Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with advanced (unresectable melanoma (stage III)) or metastatic (stage IV) melanoma and starting an Immune Checkpoint Inhibitor treatment (Monotherapy or Combination Therapy)
  • Patient starting first cycle of Immune Checkpoint Inhibitor treatment in an ambulatory care structure
  • Treatment which can be delayed for 7 days or more
  • Age \> or = 18 years old
  • Patient with a phone and/or computer equipment
  • Patient affiliated to the french social security system
  • Patient must provide written informed consent prior to any study-specific procedure or assessment

You may not qualify if:

  • Patient with diagnosis other than advanced melanoma
  • Patient who must receive a treatment other than Immune Checkpoint Inhibitor
  • Treatment administered during a conventional hospital stay (period of more than 24 hours)
  • Patient with no caregiver
  • Pregnant or breastfeeding women
  • 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
  • Patient protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Saint André, CHU de Bordeaux

Bordeaux, 33076, France

Location

Institut claudius regaud IUCT ONCOPOLE

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 6, 2017

Study Start

December 26, 2017

Primary Completion

February 19, 2021

Study Completion

February 19, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

FR(2)