Solid Tumor, AdultQdV-ONCOREANCT04310033
Impact of ICU on the Quality of Life in Cancer Patients
An observational study of Solid Tumor, Adult, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Questionnaires
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 13 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung, head and neck or colorectal cancer admitted in ICU (cases) or not (controls)
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor, Adult
- Being tested
- Questionnaires
- Keywords
- Quality of life, Oncological care, intensive care unit, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 6 months
ECOG - Performance status
From 0 (fully active) to 5 (dead)
Measured: 3 months and 6 months
Activities of Daily Living
From 0 (dependent ) to 6 (autonomous)
Measured: 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)
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start24 Feb 2020
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310033
- Sponsor's protocol ID
- 38RC19.420
- Other IDs
- 2019-A03307-40
- Acronym
- QdV-ONCOREA
- Status last verified
- Aug 2021
- First submitted
- 20 Feb 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT04310033
- Acronym / sponsor ID
- QdV-ONCOREA / 38RC19.420
- Conditions
- Solid Tumor, Adult
- Keywords
- Quality of life, Oncological care, intensive care unit, solid tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: 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 |
| Controls | – | Other: QuestionnairesCancer 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung, head and neck or colorectal cancer admitted in ICU (cases) or not (controls)
Key inclusion criteria (7 listed)
- > 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone | Other | Cases, Controls |
Primary outcome
quality of life questionary 36-item short form survey instrument (36-SF)
Time frame: 3 months
score of 0 (poor quality of life) to 100 (very good quality of life)
6 secondary outcomes
intensity of antitumoral treatment compared to standard treatment
Time frame: 3 months
quality of life questionary 36-item short form survey instrument (36-SF)
Time frame: 6 months
intensity of antitumoral treatment compared to standard treatment
Time frame: 6 months
ECOG - Performance status
Time frame: 3 months and 6 months
Activities of Daily Living
Time frame: 6 months
Hospital Anxiety and Depression Scale
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life questionary 36-item short form survey instrument (36-SF) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.