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Completed

NCT Number: NCT04310033

Impact of ICU on the Quality of Life in Cancer Patients

This is an observational, prospective, monocentric, case-control study. Investigators aim to compare the quality of life and oncological treatment strategy in cancer patients admitted or not in ICU.

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes

Grenoble, 38043, France

About this study

Inclusion of cancer patients (cases) at discharge of surgical, cardiovascular and thoracic and medical ICU of the Grenoble Alpes University Hospital.

Cases will be matched with cancer patients identified in oncologist's consultation.

Inclusion of controls from oncologist consultations (2 controls for 1 case) For cases and controls, medical data will be collected at inclusion, 3 and 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 ans
  • Non-opposition of the patient or relatives
  • Lung, head and neck or colorectal cancer
  • Non scheduled ICU admission
  • At least 24 hours of ICU stay
  • Alive at ICU discharge
  • Able to answer by phone to quality of life questionary

Exclusion criteria

  • Unable to answer by phone to quality of life questionary
  • Patient participating in another clinical study that could interfere with the results of the study

Treatment and study plan

questionnaires

Other

Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone

Primary outcomes

  1. quality of life questionary 36-item short form survey instrument (36-SF)

    Time frame: 3 months

    score of 0 (poor quality of life) to 100 (very good quality of life)

Secondary outcomes

  1. intensity of antitumoral treatment compared to standard treatment

    Time frame: 3 months

    standard treatment vs adaptated treatment vs palliative care standard treatment was defined by the treatment recommended in the ESMO guidelines for each cancer (lung, colorectal, and head and neck cancer)

  2. quality of life questionary 36-item short form survey instrument (36-SF)

    Time frame: 6 months

    score of 0 (poor quality of life) to 100 (very good quality of life)

  3. intensity of antitumoral treatment compared to standard treatment

    Time frame: 6 months

    standard treatment vs adaptated treatment vs palliative care standard treatment was defined by the treatment recommended in the ESMO guidelines for each cancer (lung, colorectal, and head and neck cancer)

  4. ECOG - Performance status

    Time frame: 3 months and 6 months

    From 0 (fully active) to 5 (dead)

  5. Activities of Daily Living

    Time frame: 6 months

    From 0 (dependent ) to 6 (autonomous)

  6. Hospital Anxiety and Depression Scale

    Time frame: 3 months and 6 months

    Anxiety scale from 0 (no anxiety) to 21 (anxiety) Depression Scale from 0 (no depression) to 21 (depression)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors

Acronym: QdV-ONCOREA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2020
Registry last updated
Sep 1, 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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