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OpenTrials
Completed

NCT Number: NCT03329755

Optimization of the Patient Care Pathway in Immuno-oncology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint André, CHU de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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 follow-up during the treatment period

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

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

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: OPTIMMUNO

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2017
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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