Impact of ICU on the Quality of Life in Cancer Patients (QdV-ONCOREA)
August 31, 2021 updated by: University Hospital, Grenoble
Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Grenoble Cedex 9, France, 38043
- CHU Grenoble Alpes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Lung, head and neck or colorectal cancer admitted in ICU (cases) or not (controls)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cases
|
Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone
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|
Controls
Cancer patients not admitted in ICU, matched with the cases according to
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Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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3 months
|
|
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)
|
6 months
|
|
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)
|
6 months
|
|
ECOG - Performance status
Time Frame: 3 months and 6 months
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From 0 (fully active) to 5 (dead)
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3 months and 6 months
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Activities of Daily Living
Time Frame: 6 months
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From 0 (dependent ) to 6 (autonomous)
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6 months
|
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Hospital Anxiety and Depression Scale
Time Frame: 3 months and 6 months
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Anxiety scale from 0 (no anxiety) to 21 (anxiety) Depression Scale from 0 (no depression) to 21 (depression)
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3 months and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2020
Primary Completion (Actual)
July 13, 2021
Study Completion (Actual)
July 13, 2021
Study Registration Dates
First Submitted
February 20, 2020
First Submitted That Met QC Criteria
March 12, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
September 1, 2021
Last Update Submitted That Met QC Criteria
August 31, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 38RC19.420
- 2019-A03307-40 (Other Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.