Systemic TreatmentQUALINCT03743961
Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia
An observational study of Systemic Treatment and Metastatic Neoplasia, run by Institut de Cancérologie de la Loire at 1 site in France.
Trial summary
The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Systemic Treatment, Metastatic Neoplasia, Elderly Patients
- What is being tested?
- geriatric intervention
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2018to 2 Jul 2020
- 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
- Older adult
Study population: Patients with minimum 75 years old will perform two questionnaires about quality of life and then, according to these scores they will perform a geriatric intervention.
Who may be able to join
- Patient with solid metastatic neoplasia
- 75 years old or more
- Men or women
- ECOG between 0 and 3
- Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)
Who cannot join
- ECOG 4
- Localized cancer
- Patients already included in a study witch could modify quality of life
- Patient unable to give their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
About this study
Official title: Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia
Read the detailed description
Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.
- Conditions
- Systemic Treatment, Metastatic Neoplasia, Elderly Patients
- Being tested
- geriatric intervention
- Keywords
- quality of life, elderly, metastatic neoplasia, systemic therapies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geriatric interventionOther
Geriatric intervention
| Study group | Role | What they receive |
|---|---|---|
| Group A : control group | Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) and QoL EORTC Q30 (Quality Qf Life with 30 Questions) for patients with G8 score > 14/17 | |
| Group B : geriatric intervention group | Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients) and QoL (Quality Qf Life) EORTC Q30 for patients with G8 score ≤14/17 ( in this arm there is two groups : patient who received geriatric intervention before treatment initiation (group A) and group of patient did not received geriatric intervention before treatment initiation( group B)) Receives: Other: geriatric intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of quality of life
Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions)
Measured: 6 months
Level of quality of life
Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)
Measured: 6 months
Secondary outcomes (3)
number of hospitalizations
number of hospitalizations will be reported
Measured: 6 months
Duration of hospitalizations
Duration of hospitalizations will be reported in hours
Measured: 6 months
Number of toxicities ( grade 3 and 4)
Number of toxicities (grade 3 and 4) will be reported according to the CTCAE v4.0 (Common Terminology Criteria for Adverse Events)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start21 Nov 2018
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Why it stopped: Low rythm of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic TreatmentStudies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blandine De Lavigerie, MD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743961
- Sponsor's protocol ID
- 2018-0801
- Other IDs
- 2018-A02315-50
- Acronym
- QUALI
- Status last verified
- Jul 2020
- First submitted
- 8 Oct 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
- ClinicalTrials.gov ID
- NCT03743961
- Acronym / sponsor ID
- QUALI / 2018-0801
- Conditions
- Systemic Treatment, Metastatic Neoplasia, Elderly Patients
- Keywords
- quality of life, elderly, metastatic neoplasia, systemic therapies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low rythm of inclusions
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 16 Nov 2018 (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.
The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia
Detailed description
Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : control group | – | –Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) and QoL EORTC Q30 (Quality Qf Life with 30 Questions) for patients with G8 score > 14/17 |
| Group B : geriatric intervention group | – | Other: geriatric interventionEvaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients) and QoL (Quality Qf Life) EORTC Q30 for patients with G8 score ≤14/17 ( in this arm there is two groups : patient who received geriatric intervention before treatment initiation (group A) and group of patient did not received geriatric intervention before treatment initiation( group B)) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients with minimum 75 years old will perform two questionnaires about quality of life and then, according to these scores they will perform a geriatric intervention.
Key inclusion criteria (5 listed)
- Patient with solid metastatic neoplasia
- 75 years old or more
- Men or women
- ECOG between 0 and 3
- Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)
Key exclusion criteria (4 listed)
- ECOG 4
- Localized cancer
- Patients already included in a study witch could modify quality of life
- Patient unable to give their consent
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 |
|---|---|---|
| geriatric interventionGeriatric intervention | Other | Group B : geriatric intervention group |
Primary outcome
Level of quality of life
Time frame: 6 months
Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions)
Level of quality of life
Time frame: 6 months
Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)
3 secondary outcomes
number of hospitalizations
Time frame: 6 months
Duration of hospitalizations
Time frame: 6 months
Number of toxicities ( grade 3 and 4)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Low rythm of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Blandine De Lavigerie, MD principal investigator
Institut de Cancérologie Lucien Neuwirth
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 Systemic Treatment and Metastatic Neoplasia, run by Institut de Cancérologie de la Loire 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Jul 2020. 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 was stopped early (reason given: Low rythm of inclusions). Results are not available in the source record.
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?
Level of quality of life (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Jul 2020.