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CompletedNCT03329755OPTIMMUNOUpdated Feb 24, 2021

Optimization of the Patient Care Pathway in Immuno-oncology

An interventional study of Dedicated and coordinated e-follow-up during the treatment period and Standard follow-up during the treatment period in Melanoma, sponsored by Institut Claudius Regaud. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Melanoma

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Keywords

  • Advanced melanoma
  • Immune checkpoint
  • E-follow-up
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    Experimental

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

  • Other
    Standard

    Other: Standard follow-up during the treatment period

Interventions

  • OtherDedicated 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)

  • OtherStandard follow-up during the treatment period

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

05

What researchers measure

Primary outcomes

  1. Average length of administrative stay in the hospital

    Time frame: 3 months by patient

Secondary outcomes

  1. Number of cancelled or delayed hospital stay

    Time frame: 3 months by patient

  2. Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)

    Time frame: 3 months by patient

  3. Treatment response rate at 3 months

    Time frame: 3 months by patient

  4. Correlation between the day hospital stay and the patient general health

    Time frame: 3 months by patient

  5. Frequency of web interface completion (Experimental arm only)

    Time frame: 3 months by patient

  6. Patient satisfaction to the e-follow-up (Experimental arm only)

    Time frame: 3 months by patient

  7. Rate of reclassified alerts after intervention of nurse (Experimental arm only)

    Time frame: 3 months by patient

06

Study locations

2 sites
  • Hôpital Saint André, CHU de Bordeaux
    Bordeaux, 33076, France
  • Institut claudius regaud IUCT ONCOPOLE
    Toulouse, 31059, France
07

Registry details

Key details

Study ID
NCT03329755
Lead sponsor
Institut Claudius Regaud
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Dec 26, 2017
Primary completion
Feb 19, 2021
Completion
Feb 19, 2021
Last update
Feb 24, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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