NCT04310033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

February 20, 2020

Last Update Submit

August 31, 2021

Conditions

Solid Tumor, Adult

Keywords

Quality of lifeOncological careintensive care unitsolid tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • intensity of antitumoral treatment compared to standard treatment

    3 months

  • quality of life questionary 36-item short form survey instrument (36-SF)

    6 months

  • intensity of antitumoral treatment compared to standard treatment

    6 months

  • ECOG - Performance status

    3 months and 6 months

  • Activities of Daily Living

    6 months

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

QuestionnairesOTHER

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

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lung, head and neck or colorectal cancer admitted in ICU (cases) or not (controls)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 17, 2020

Study Start

February 24, 2020

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

FR(1)