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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03261128
Other study ID # 2017-A02188-45
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 21, 2017
Est. completion date December 5, 2018

Study information

Verified date January 2019
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 5, 2018
Est. primary completion date September 11, 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-questionnaire
Filling of a self-questionnaire before each chemotherapy cure

Locations

Country Name City State
France CHU Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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