Impact of ICU on the Quality of Life in Cancer Patients

Solid Tumor, Adult Clinical Trial

— QdV-ONCOREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310033
• Other study ID #: 38RC19.420
• Secondary ID: 2019-A03307-40
• Status: Completed
• Start date: February 24, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

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

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	ECOG - Performance status	From 0 (fully active) to 5 (dead)	3 months and 6 months
Secondary	Activities of Daily Living	From 0 (dependent ) to 6 (autonomous)	6 months
Secondary	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