Feasibility of Supportive Care Needs in Patients With Advanced Solid Cancer in a Therapeutic Trial (ES4-UIC)

December 2, 2022 updated by: Institut Curie

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • Institut Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all comers for a clinical trial

Description

Inclusion Criteria:

  • metastatic cancer
  • patient included in a clinical trial

Exclusion Criteria:

- patient deprived of his freedom

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: Pauline du Rusquec, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2020-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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