Impact of ICU on the Quality of Life in Cancer Patients

Completed

• Conditions: Solid Tumor, Adult
• Interventions: Other: Questionnaires

• Registration Number: NCT04310033
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-02-20
• Study Start: 2020-02-24
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-17
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Questionnaires	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).
Cases	Questionnaires	* \> 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

Primary Outcome Measures

Name	Time	Method
quality of life questionary 36-item short form survey instrument (36-SF)	3 months	score of 0 (poor quality of life) to 100 (very good quality of life)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble Cedex 9, France