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

Sponsor
Institut Curie (Other)
Overall Status
Recruiting
CT.gov ID
NCT04896099
Collaborator
(none)
65
1
12.7
5.1

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    65 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jun 7, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) [3 months]

      Descritive results with validated questionnaire for the assessment of Quality of life in patient with cancer. 30 Questions

    2. National Comprehensive Cancer Network (NCCN) Distress thermometer [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. Questionnaire G8 oncodage [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • metastatic cancer

    • patient included in a clinical trial

    Exclusion Criteria:
    • patient deprived of his freedom

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Curie Paris France 75005

    Sponsors and Collaborators

    • Institut Curie

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Curie
    ClinicalTrials.gov Identifier:
    NCT04896099
    Other Study ID Numbers:
    • IC 2020-18
    First Posted:
    May 21, 2021
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 9, 2021