Tool for the Detection of Oncogeriatric Fragility in Pati... | NCT03261128

Studies
Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)

NCT03261128

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jan 29, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

75 Years Old and More
Cancer
Chemotherapy

Interventions

Self-questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2017Actual

Primary Completion Date

Sep 11, 2018Actual

Completion Date

Dec 5, 2018Actual

First Submitted Date

Aug 4, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2019

Last Update Posted Date

Jan 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Number of D-FOGs filled in: comparison with the number of patients included in the study and the number of visits of each patient.
Regularity of the D-FOG self-questionnaire by the patient: comparison with the number of visits of the patient for a chemotherapy cure (HDJ or HDS).
Number of criteria entered by D-FOG: comparison with the total number of criteria to be filled in
Criterion analysis of D-FOG

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group D-FOG		Filling of a self-questionnaire before each chemotherapy cure	Other: Self-questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-questionnaire	Other	Filling of a self-questionnaire before each chemotherapy cure	Group D-FOG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients aged 75 years and over Cancer and treated with chemotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
VALERO SV SIMON, Doctor	CHU Poitiers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU		Poitiers		86000	France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided