NCT04896099

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

May 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

May 6, 2021

Last Update Submit

December 2, 2022

Conditions

Supportive CareMetastatic CancerClinical Trial

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    3 months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all comers for a clinical trial

You may qualify if:

  • metastatic cancer
  • patient included in a clinical trial

You may not qualify if:

  • \- patient deprived of his freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pauline du Rusquec, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 21, 2021

Study Start

June 7, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

December 5, 2022

Record last verified: 2022-12

Locations

FR(1)