Quality of LifeFARAPPACNCT04478903
Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management
An observational study of Quality of Life and Primary Patient Caregiver, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Primary Patient Caregiver, Cancer
- What is being tested?
- Questionnaire
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 16 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrieval of information and contact details of primary caregivers included in the 2014 study along with the patient's vital status
Who may be able to join
- Person who does not object to being included in the study
- Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015.
- Age ≥ 18 years old
- Good command of the French language
Who cannot join
- Refusal or linguistic or psychological inability to answer the questionnaires.
- Caregiver whose general condition does not allow him/her to answer a questionnaire
- Death of the caregiver.
Trial locations and contacts
1 site in 1 country.
About this study
Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.
The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.
- Conditions
- Quality of Life, Primary Patient Caregiver, Cancer
- Being tested
- Questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Zarit Burden Inventory French version and SF12
| Study group | Role | What they receive |
|---|---|---|
| primary caregiver of patients aged 70 and over | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.
Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Jun 2020
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478903
- Sponsor's protocol ID
- QUIPOURT 2019
- Acronym
- FARAPPAC
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barben J, Billa O, Collot J, Collot T, Manckoundia P, Bengrine-Lefevre L, Dabakuyo-Yonli TS, Quipourt V. Quality of life and perceived burden of the primary caregiver of patients aged 70 and over with cancer 5 years after initial treatment. Support Care Cancer. 2023 Feb 2;31(2):147. doi: 10.1007/s00520-023-07594-w.
PubMed 36729239
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management
- ClinicalTrials.gov ID
- NCT04478903
- Acronym / sponsor ID
- FARAPPAC / QUIPOURT 2019
- Conditions
- Quality of Life, Primary Patient Caregiver, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 21 Jul 2020 (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.
Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.
The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary caregiver of patients aged 70 and over | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrieval of information and contact details of primary caregivers included in the 2014 study along with the patient's vital status
Key inclusion criteria (4 listed)
- Person who does not object to being included in the study
- Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015.
- Age ≥ 18 years old
- Good command of the French language
Key exclusion criteria (3 listed)
- Refusal or linguistic or psychological inability to answer the questionnaires.
- Caregiver whose general condition does not allow him/her to answer a questionnaire
- Death of the caregiver.
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 |
|---|---|---|
| QuestionnaireZarit Burden Inventory French version and SF12 | Other | primary caregiver of patients aged 70 and over |
Primary outcome
To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.
Time frame: Through study completion, an average of 1 year
Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36).
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 10 Mar 2021.
- Derived from this study: PubMed 36729239Barben J, Billa O, Collot J, Collot T, Manckoundia P, Bengrine-Lefevre L, Dabakuyo-Yonli TS, Quipourt V. Quality of life and perceived burden of the primary caregiver of patients aged 70 and over with cancer 5 years after initial treatment. Support Care Cancer. 2023 Feb 2;31(2):147. doi: 10.1007/s00520-023-07594-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Quality of Life and Primary Patient Caregiver, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 3 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 10 Mar 2021. 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?
To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478903, which also lists 1 linked publication.
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 10 Mar 2021.