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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Completed
• CT.gov ID: NCT04310033
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 16.6
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult	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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors
• Actual Study Start Date: Feb 24, 2020
• Actual Primary Completion Date: Jul 13, 2021
• Actual Study Completion Date: Jul 13, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. intensity of antitumoral treatment compared to standard treatment [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) [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 [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 [3 months and 6 months]

   From 0 (fully active) to 5 (dead)

5. Activities of Daily Living [6 months]

   From 0 (dependent ) to 6 (autonomous)

6. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Grenoble Alpes	Grenoble Cedex 9		France	38043

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04310033
• Other Study ID Numbers: 38RC19.420; 2019-A03307-40
• First Posted: Mar 17, 2020
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: Quality of life; Oncological care; intensive care unit; solid tumor

Study Results

No Results Posted as of Sep 1, 2021