75 Years Old and MoreD-FOGNCT03261128
Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)
An observational study of 75 Years Old and More and Cancer, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- 75 Years Old and More, Cancer, Chemotherapy
- What is being tested?
- Self-questionnaire
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2017to 5 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 75 years and over Cancer and treated with chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment. Feasibility and Acceptability Study.
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.
Read the 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
- Conditions
- 75 Years Old and More, Cancer, Chemotherapy
- Being tested
- Self-questionnaire
- Keywords
- cancer, chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaireOther
Filling of a self-questionnaire before each chemotherapy cure
| Study group | Role | What they receive |
|---|---|---|
| Group D-FOG | Filling of a self-questionnaire before each chemotherapy cure Receives: Other: Self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start21 Nov 2017
- Primary completion11 Sep 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 75 Years Old and MoreStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VALERO SV SIMON, Doctor, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261128
- Sponsor's protocol ID
- 2017-A02188-45
- Acronym
- D-FOG
- Status last verified
- Jan 2019
- First submitted
- 4 Aug 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment. Feasibility and Acceptability Study.
- ClinicalTrials.gov ID
- NCT03261128
- Acronym / sponsor ID
- D-FOG / 2017-A02188-45
- Conditions
- 75 Years Old and More, Cancer, Chemotherapy
- Keywords
- cancer, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group D-FOG | – | Other: Self-questionnaireFilling of a self-questionnaire before each chemotherapy cure |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 75 years and over Cancer and treated with chemotherapy
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaireFilling of a self-questionnaire before each chemotherapy cure | Other | Group D-FOG |
Primary outcome
Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment.
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VALERO SV SIMON, Doctor principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 75 Years Old and More and Cancer, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.