Impact of ICU on the Quality of Life in Cancer Patients (QdV-ONCOREA)

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

• Status: Completed
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Other: Questionnaires

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

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • Chu Grenoble Alpes

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; > 18 years old; 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	Other: Questionnaires; Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone
Controls; Cancer patients not admitted in ICU, matched with the cases according to; the type of primary cancer; the presence or absence of oncogenic addiction; the setting of anticancer treatment (curative/palliative); the line of anticancer treatment (none/L1/L2-L3/>L3).	Other: Questionnaires; Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone

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)	score of 0 (poor quality of life) to 100 (very good quality of life)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intensity of antitumoral treatment compared to standard treatment	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)	3 months
quality of life questionary 36-item short form survey instrument (36-SF)	score of 0 (poor quality of life) to 100 (very good quality of life)	6 months
intensity of antitumoral treatment compared to standard treatment	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	From 0 (fully active) to 5 (dead)	3 months and 6 months
Activities of Daily Living	From 0 (dependent ) to 6 (autonomous)	6 months
Hospital Anxiety and Depression Scale	Anxiety scale from 0 (no anxiety) to 21 (anxiety) Depression Scale from 0 (no depression) to 21 (depression)	3 months and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

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

• Keywords: intensive care unit; Quality of life; solid tumor; Oncological care
• 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