Supportive CareES4-UICNCT04896099
Feasibility of Supportive Care Needs in Patients With Advanced Solid Cancer in a Therapeutic Trial
An observational study of Supportive Care and Metastatic Cancer, run by Institut Curie at 1 site in France.
Trial summary
The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Supportive Care, Metastatic Cancer, Clinical Trial
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 15 Dec 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 to 100 years
- All sexes
- Adult, Older adult
Study population: all comers for a clinical trial
Who may be able to join
- metastatic cancer
- patient included in a clinical trial
Who cannot join
- patient deprived of his freedom
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Observational Study Evaluating the Feasibility of a Systematic and Standardized Assessment of Supportive Care Needs in Patients With Advanced Solid Cancer at the Inclusion in a Therapeutic Trial at the Institut Curie
The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.
Read the detailed description
All patients included in a therapeutic trial will be offered an analysis of their supportive care needs from the following options:
- dietetics
- psychological
- pain management
- Palliative medicine consultation or day hospital
- onco-geriatrics
- social assistance
- Physiotherapist care If an intervention(s) is selected, it will be offered in addition to the patient's participation in the therapeutic trial.
- Conditions
- Supportive Care, Metastatic Cancer, Clinical Trial
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Descritive results with validated questionnaire for the assessment of Quality of life in patient with cancer. 30 Questions
Measured: 3 months
National Comprehensive Cancer Network (NCCN) Distress thermometer
Descritive results with validated questionnaire for distress assessment (scale from 0 to 10 and list of problems to be ticked by the patient
Measured: 3 months
Questionnaire G8 oncodage
Descritive results with validated questionnaire for the identification of geriatric frailties in 70 year old cancer patients. Score on 17 points: > 14 = standard care, <14 = specialized geriatric evaluation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start7 Jun 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline du Rusquec, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896099
- Sponsor's protocol ID
- IC 2020-18
- Acronym
- ES4-UIC
- Status last verified
- Dec 2022
- First submitted
- 6 May 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study Evaluating the Feasibility of a Systematic and Standardized Assessment of Supportive Care Needs in Patients With Advanced Solid Cancer at the Inclusion in a Therapeutic Trial at the Institut Curie
- ClinicalTrials.gov ID
- NCT04896099
- Acronym / sponsor ID
- ES4-UIC / IC 2020-18
- Conditions
- Supportive Care, Metastatic Cancer, Clinical Trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 21 May 2021 (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.
The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.
Detailed description
All patients included in a therapeutic trial will be offered an analysis of their supportive care needs from the following options:
- dietetics
- psychological
- pain management
- Palliative medicine consultation or day hospital
- onco-geriatrics
- social assistance
- Physiotherapist care If an intervention(s) is selected, it will be offered in addition to the patient's participation in the therapeutic trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all comers for a clinical trial
Key inclusion criteria (2 listed)
- metastatic cancer
- patient included in a clinical trial
Key exclusion criteria (1 listed)
- patient deprived of his freedom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 3 months
Descritive results with validated questionnaire for the assessment of Quality of life in patient with cancer. 30 Questions
National Comprehensive Cancer Network (NCCN) Distress thermometer
Time frame: 3 months
Descritive results with validated questionnaire for distress assessment (scale from 0 to 10 and list of problems to be ticked by the patient
Questionnaire G8 oncodage
Time frame: 3 months
Descritive results with validated questionnaire for the identification of geriatric frailties in 70 year old cancer patients. Score on 17 points: > 14 = standard care, <14 = specialized geriatric evaluation
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 5 Dec 2022.
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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.
Pauline du Rusquec, MD principal investigator
Institut Curie
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 Supportive Care and Metastatic Cancer, run by Institut Curie 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 2 inclusion and 1 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 5 Dec 2022. 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?
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 5 Dec 2022.