Caregiver Quality of LifeQUAVIDANCT07704073
Quality of Life of Caregivers Supporting an Older Adult With Cancer
An observational study of Caregiver Quality of Life and Geriatric Oncology, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The French population is aging, and the number of newly diagnosed cancers among individuals aged 75 years and older continues to increase. The development of geriatric medicine, and particularly geriatric oncology, in collaboration with surgical and medical oncology specialists, has expanded access to innovative… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Quality of Life, Geriatric Oncology, Geriatric Medicine
- What is being tested?
- CarGOQol scale
- How many people
- 116 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will consist of patient-caregiver dyads, including patients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver.
Who may be able to join
- Patient:
- Aged 70 years or older.
- Attending a first geriatric oncology consultation.
- Histologically confirmed diagnosis of cancer.
- Accompanied by a primary informal caregiver at the consultation.
- Caregiver:
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- Aged 18 years or older.
- Dyad:
- The patient and caregiver have been informed about the study and do not object to participation, in accordance with French regulations governing non-interventional research.
Who cannot join
- Patient:
- Unable to express non-opposition to participation (e.g., under legal guardianship or presenting severe neurocognitive impairment as assessed during the consultation).
- Language barrier preventing study participation when the caregiver is unable to provide adequate interpretation.
- Objection to participation.
- Not affiliated with the French national health insurance system.
- Beneficiary of State Medical Aid
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- Caregiver:
- Unable to understand or complete study questionnaires in French.
- Clinically significant cognitive impairment identified during the consultation.
- Objection to participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The French population is aging, and the number of newly diagnosed cancers among individuals aged 75 years and older continues to increase. The development of geriatric medicine, and particularly geriatric oncology, in collaboration with surgical and medical oncology specialists, has expanded access to innovative anticancer therapies for older adults. Although these treatments have improved therapeutic options, they are associated with adverse effects that may lead to functional decline and reduced quality of life in older patients. These consequences may also adversely affect the well-being and quality of life of their informal caregivers.
The role of informal caregivers has progressively become an integral component of cancer care. It is well established that providing care to a relative with a chronic illness can negatively impact caregivers' physical and psychological health, as well as their quality of life. While older patients are increasingly monitored through specialized geriatric oncology consultations, caregivers rarely receive systematic assessment or follow-up. Understanding the factors associated with caregiver quality of life is therefore essential to improve comprehensive patient-centered care in geriatric oncology.
This prospective observational study aims to investigate the association between baseline comprehensive geriatric assessment parameters of older patients with cancer-including functional status, nutritional status, cognition, mood, physical performance, sensory impairment, and comorbidities-and the quality of life of their caregiver. Caregiver quality of life will be assessed using the validated CarGOQoL questionnaire. Patient-caregiver dyads will be followed for six months, corresponding to the usual period for evaluating treatment tolerance and effectiveness. The findings may help identify caregivers at risk of impaired quality of life and support the integration of caregiver assessment into routine geriatric oncology practice.
Read the detailed description
The French population is aging, with approximately one in ten individuals now over 75 years of age. This demographic trend is accompanied by an increasing incidence of cancer, which remains the leading cause of mortality ahead of cardiovascular diseases across all age groups. In older adults with cancer, treatment-related adverse events are more likely to result in dose reductions or treatment discontinuation than in younger populations, particularly with chemotherapy and immunotherapy.
In geriatric oncology, regular patient reassessment is essential to evaluate treatment tolerance, monitor toxicities, detect and prevent functional decline, and identify deterioration in comorbidities. According to the literature, comprehensive geriatric reassessments are generally performed at 3, 6, or 12 months after treatment initiation.
The World Health Organization (WHO) defines quality of life (QoL) as an individual's perception of their position in life within the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns. QoL is a multidimensional concept encompassing physical health, psychological status, level of independence, social relationships, personal beliefs, and interactions with the surrounding environment. It includes both objective components (e.g., functional status, symptom burden) and subjective dimensions (e.g., personal fulfillment, life satisfaction, and well-being), making it a highly individualized and dynamic outcome.
Over the past two decades, recognition of informal caregivers has progressively increased within successive French National Cancer Plans. The term ""caregiver"" was formally introduced into the 2014-2019 Cancer Plan, reflecting the growing acknowledgement of the essential role played by family members and other non-professional caregivers. An informal caregiver is defined as a person who provides regular, unpaid assistance to an older dependent individual or a person with disabilities, helping with activities of daily living, nursing care, coordination of care, administrative tasks, psychological support, supervision, social participation, and household activities.
Government policies supporting caregivers emerged relatively late in France. Until the early 2000s, caregiver support was largely considered a private family responsibility. Financial pressures on healthcare and home-care systems subsequently highlighted the need for structured caregiver support, which has since become an integral component of national cancer strategies.
Treatment-related toxicities, functional decline, and malnutrition negatively affect the quality of life of older patients with cancer and also have a substantial impact on the quality of life of their caregivers. Balancing quality of life with survival therefore represents one of the major challenges in geriatric oncology.
Although several studies have evaluated quality of life among older patients with cancer, very few have focused on the quality of life of their primary caregivers. Symptoms such as dyspnea and pain are known to impair patients' quality of life at the end of life. In caregivers, dyspnea experienced by the patient, caregiver anxiety, and depression have been associated with increased caregiver burden. Greater caregiver burden has also been correlated with increased fatigue, anxiety, depression, and poorer overall health among caregivers.
Several validated instruments are available to assess patient quality of life, including the EORTC QLQ-C30, the EORTC QLQ-ELD14 for patients aged 70 years and older, and the SF-36 questionnaire. Caregiver burden and caregiver quality of life can be assessed using validated instruments such as the Mini-Zarit Burden Interview and the CarGOQoL questionnaire, respectively. These tools allow the experiences, concerns, and difficulties of both patients and caregivers to be quantified and integrated into comprehensive supportive care.
The French National Cancer Plan (2014-2019) emphasized the importance of incorporating caregivers' perspectives into comprehensive patient management, improving caregivers' access to supportive care services, and facilitating access to respite care. Identifying caregiver needs has therefore become a priority for healthcare organizations.
Caregivers play a central role in supporting older adults living with chronic diseases such as cancer. In neurocognitive disorders, caregiver burden is already considered an essential component of comprehensive geriatric assessment of the patient-caregiver dyad. This approach promotes coordinated care involving both hospital-based teams and community healthcare services.
Consequently, it has become important in geriatric oncology to identify the factors associated with caregiver quality of life so that caregiver-related outcomes can ultimately be incorporated into the initial comprehensive geriatric assessment, similarly to cognitive impairment.
Older adults remain underrepresented in oncology research despite the growing public health importance of cancer management in this population. Informal caregivers play a critical role in supporting older patients throughout their cancer journey, and caregiver burden may also influence patients' treatment decisions when they are aware of its impact.
The study will investigate the association between baseline comprehensive geriatric assessment parameters of older patients-including functional status, nutritional status, cognitive function, physical performance, mood, sensory impairments, and comorbidities-and the quality of life of their primary caregiver, as assessed using the validated CarGOQoL questionnaire.
The planned recruitment period has been determined to allow enrollment of a sufficient number of patient-caregiver dyads to adequately address the study objective.
Participants will be followed for six months, corresponding to the usual duration required to initiate systemic anticancer treatment and assess its tolerance and effectiveness, or, in patients receiving curative treatment, the effective duration of the planned therapeutic management.
- Being tested
- CarGOQol scale
- Keywords
- CArGOQol, caregiver, oncology, geriatric
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarGOQol scaleOther
caregiver quality of life, assessed using the CarGOQoL scale
| Study group | Role | What they receive |
|---|---|---|
| Less frail older patient-caregiver dyads | patients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver of less frail older patients Receives: Other: CarGOQol scale | |
| most frail older patients-caregiver dyads | patients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver of most frail older patients Receives: Other: CarGOQol scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether patient frailty, measured by the G8 screening tool, identifies caregivers at increased risk of poorer quality of life, assessed using the CarGOQoL scale.
To assess the association between patient frailty, as measured by the G8 screening tool, and the quality of life of their primary informal caregiver, assessed using the CarGOQoL scale
Measured: at inclusion
Secondary outcomes (7)
To identify patient-related factors from the comprehensive geriatric assessment independently associated with poorer caregiver quality of life
Association between caregiver quality of life, assessed using the CarGOQoL scale, and individual domains of the patient's baseline comprehensive geriatric assessment, including functional status, nutritional status, cognitive function, physical performance, mood, sensory impairment, comorbidity burden, polypharmacy, and pain.
Measured: at inclusion
Number of hospitalizations or unscheduled healthcare visits
Measured: 6 month
Reason of hospitalizations or unscheduled healthcare visits
Measured: 6 month
Caregiver burden assessed using the Mini-Zarit Burden Interview
Measured: at inclusion
Correlation between caregiver burden, assessed using the Mini-Zarit Burden Interview, and caregiver quality of life, assessed using the CarGOQoL scale
Measured: at inclusion
Patient living situation
Number of patients living in institutions
Measured: at 6 month
Number of patients who died
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Quality of LifeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amelie Aregui, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704073
- Sponsor's protocol ID
- APHP260220
- Other IDs
- 2026-A00396-45
- Acronym
- QUAVIDA
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Caregivers Supporting an Older Adult With Cancer
- ClinicalTrials.gov ID
- NCT07704073
- Acronym / sponsor ID
- QUAVIDA / APHP260220
- Keywords
- CArGOQol, caregiver, oncology, geriatric
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Jul 2026 (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 French population is aging, and the number of newly diagnosed cancers among individuals aged 75 years and older continues to increase. The development of geriatric medicine, and particularly geriatric oncology, in collaboration with surgical and medical oncology specialists, has expanded access to innovative anticancer therapies for older adults. Although these treatments have improved therapeutic options, they are associated with adverse effects that may lead to functional decline and reduced quality of life in older patients. These consequences may also adversely affect the well-being and quality of life of their informal caregivers.
The role of informal caregivers has progressively become an integral component of cancer care. It is well established that providing care to a relative with a chronic illness can negatively impact caregivers' physical and psychological health, as well as their quality of life. While older patients are increasingly monitored through specialized geriatric oncology consultations, caregivers rarely receive systematic assessment or follow-up. Understanding the factors associated with caregiver quality of life is therefore essential to improve comprehensive patient-centered care in geriatric oncology.
This prospective observational study aims to investigate the association between baseline comprehensive geriatric assessment parameters of older patients with cancer-including functional status, nutritional status, cognition, mood, physical performance, sensory impairment, and comorbidities-and the quality of life of their caregiver. Caregiver quality of life will be assessed using the validated CarGOQoL questionnaire. Patient-caregiver dyads will be followed for six months, corresponding to the usual period for evaluating treatment tolerance and effectiveness. The findings may help identify caregivers at risk of impaired quality of life and support the integration of caregiver assessment into routine geriatric oncology practice.
Detailed description
The French population is aging, with approximately one in ten individuals now over 75 years of age. This demographic trend is accompanied by an increasing incidence of cancer, which remains the leading cause of mortality ahead of cardiovascular diseases across all age groups. In older adults with cancer, treatment-related adverse events are more likely to result in dose reductions or treatment discontinuation than in younger populations, particularly with chemotherapy and immunotherapy.
In geriatric oncology, regular patient reassessment is essential to evaluate treatment tolerance, monitor toxicities, detect and prevent functional decline, and identify deterioration in comorbidities. According to the literature, comprehensive geriatric reassessments are generally performed at 3, 6, or 12 months after treatment initiation.
The World Health Organization (WHO) defines quality of life (QoL) as an individual's perception of their position in life within the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns. QoL is a multidimensional concept encompassing physical health, psychological status, level of independence, social relationships, personal beliefs, and interactions with the surrounding environment. It includes both objective components (e.g., functional status, symptom burden) and subjective dimensions (e.g., personal fulfillment, life satisfaction, and well-being), making it a highly individualized and dynamic outcome.
Over the past two decades, recognition of informal caregivers has progressively increased within successive French National Cancer Plans. The term ""caregiver"" was formally introduced into the 2014-2019 Cancer Plan, reflecting the growing acknowledgement of the essential role played by family members and other non-professional caregivers. An informal caregiver is defined as a person who provides regular, unpaid assistance to an older dependent individual or a person with disabilities, helping with activities of daily living, nursing care, coordination of care, administrative tasks, psychological support, supervision, social participation, and household activities.
Government policies supporting caregivers emerged relatively late in France. Until the early 2000s, caregiver support was largely considered a private family responsibility. Financial pressures on healthcare and home-care systems subsequently highlighted the need for structured caregiver support, which has since become an integral component of national cancer strategies.
Treatment-related toxicities, functional decline, and malnutrition negatively affect the quality of life of older patients with cancer and also have a substantial impact on the quality of life of their caregivers. Balancing quality of life with survival therefore represents one of the major challenges in geriatric oncology.
Although several studies have evaluated quality of life among older patients with cancer, very few have focused on the quality of life of their primary caregivers. Symptoms such as dyspnea and pain are known to impair patients' quality of life at the end of life. In caregivers, dyspnea experienced by the patient, caregiver anxiety, and depression have been associated with increased caregiver burden. Greater caregiver burden has also been correlated with increased fatigue, anxiety, depression, and poorer overall health among caregivers.
Several validated instruments are available to assess patient quality of life, including the EORTC QLQ-C30, the EORTC QLQ-ELD14 for patients aged 70 years and older, and the SF-36 questionnaire. Caregiver burden and caregiver quality of life can be assessed using validated instruments such as the Mini-Zarit Burden Interview and the CarGOQoL questionnaire, respectively. These tools allow the experiences, concerns, and difficulties of both patients and caregivers to be quantified and integrated into comprehensive supportive care.
The French National Cancer Plan (2014-2019) emphasized the importance of incorporating caregivers' perspectives into comprehensive patient management, improving caregivers' access to supportive care services, and facilitating access to respite care. Identifying caregiver needs has therefore become a priority for healthcare organizations.
Caregivers play a central role in supporting older adults living with chronic diseases such as cancer. In neurocognitive disorders, caregiver burden is already considered an essential component of comprehensive geriatric assessment of the patient-caregiver dyad. This approach promotes coordinated care involving both hospital-based teams and community healthcare services.
Consequently, it has become important in geriatric oncology to identify the factors associated with caregiver quality of life so that caregiver-related outcomes can ultimately be incorporated into the initial comprehensive geriatric assessment, similarly to cognitive impairment.
Older adults remain underrepresented in oncology research despite the growing public health importance of cancer management in this population. Informal caregivers play a critical role in supporting older patients throughout their cancer journey, and caregiver burden may also influence patients' treatment decisions when they are aware of its impact.
The study will investigate the association between baseline comprehensive geriatric assessment parameters of older patients-including functional status, nutritional status, cognitive function, physical performance, mood, sensory impairments, and comorbidities-and the quality of life of their primary caregiver, as assessed using the validated CarGOQoL questionnaire.
The planned recruitment period has been determined to allow enrollment of a sufficient number of patient-caregiver dyads to adequately address the study objective.
Participants will be followed for six months, corresponding to the usual duration required to initiate systemic anticancer treatment and assess its tolerance and effectiveness, or, in patients receiving curative treatment, the effective duration of the planned therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less frail older patient-caregiver dyads | – | Other: CarGOQol scalepatients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver of less frail older patients |
| most frail older patients-caregiver dyads | – | Other: CarGOQol scalepatients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver of most frail older patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will consist of patient-caregiver dyads, including patients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver.
Key inclusion criteria (9 listed)
- Aged 70 years or older.
- Attending a first geriatric oncology consultation.
- Histologically confirmed diagnosis of cancer.
- Accompanied by a primary informal caregiver at the consultation.
- Aged 18 years or older.
Key exclusion criteria (10 listed)
- Unable to express non-opposition to participation (e.g., under legal guardianship or presenting severe neurocognitive impairment as assessed during the consultation).
- Language barrier preventing study participation when the caregiver is unable to provide adequate interpretation.
- Objection to participation.
- Not affiliated with the French national health insurance system.
- Beneficiary of State Medical Aid
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 |
|---|---|---|
| CarGOQol scalecaregiver quality of life, assessed using the CarGOQoL scale | Other | Less frail older patient-caregiver dyads, most frail older patients-caregiver dyads |
Primary outcome
To assess whether patient frailty, measured by the G8 screening tool, identifies caregivers at increased risk of poorer quality of life, assessed using the CarGOQoL scale.
Time frame: at inclusion
To assess the association between patient frailty, as measured by the G8 screening tool, and the quality of life of their primary informal caregiver, assessed using the CarGOQoL scale
7 secondary outcomes
To identify patient-related factors from the comprehensive geriatric assessment independently associated with poorer caregiver quality of life
Time frame: at inclusion
Number of hospitalizations or unscheduled healthcare visits
Time frame: 6 month
Reason of hospitalizations or unscheduled healthcare visits
Time frame: 6 month
Caregiver burden assessed using the Mini-Zarit Burden Interview
Time frame: at inclusion
Correlation between caregiver burden, assessed using the Mini-Zarit Burden Interview, and caregiver quality of life, assessed using the CarGOQoL scale
Time frame: at inclusion
Patient living situation
Time frame: at 6 month
Number of patients who died
Time frame: at 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Amelie Aregui, MD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Quality of Life and Geriatric Oncology, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Aregui, MS (01 53 11 17 72 ext. 33, amelie.aregui@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether patient frailty, measured by the G8 screening tool, identifies caregivers at increased risk of poorer quality of life, assessed using the CarGOQoL scale. (time frame: at inclusion). 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 15 Jul 2026.