NCT03261128

Brief Summary

Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a self-administered questionnaire carried out by the patient before each chemotherapy cure. The objective is to secure the quality of patient care and to detect the appearance and / or aggravation of geriatric fragilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

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

August 4, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

August 4, 2017

Last Update Submit

January 28, 2019

Conditions

Keywords

cancerchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment.

    Feasibility of D-FOG for patients : number of D-FOGs filled in, regularity of the D-FOG self-questionnaire by the patient, number of criteria entered by D-FOG, criterion analysis of D-FOG

    3 months

Study Arms (1)

Group D-FOG

Filling of a self-questionnaire before each chemotherapy cure

Other: Self-questionnaire

Interventions

Filling of a self-questionnaire before each chemotherapy cure

Group D-FOG

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 75 years and over Cancer and treated with chemotherapy

You may qualify if:

  • Patients aged 75 years and over
  • Carriers of diagnosed cancer (excluding hematology)
  • Whatever the location, uniqueness or multiple, duration of development and treatment status (adjuvant, neoadjuvant, locally advanced or metastatic)
  • Seen in nursing consultant
  • Beginning an oncological treatment
  • Supported for oncology day hospital (HDJ) or weekly (HDS) chemotherapy
  • Patient not opposed to participate in the study

You may not qualify if:

  • Patients under 75 years of age
  • Having not had an IDE ad consultation
  • During oncological treatment
  • Receiving Oral Therapy or hormone therapy alone
  • Treated by radiotherapy alone or surgery alone
  • Not attending a day or week oncology hospital
  • Refusal to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • VALERO SV SIMON, Doctor

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 24, 2017

Study Start

November 21, 2017

Primary Completion

September 11, 2018

Study Completion

December 5, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations