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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

France2 sites
  • Hôpital Bretonneau

    Paris, 75018

  • Hôpital Saint Louis

    Paris, 758010

Other trials in France

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 groups in NCT07704073
Study groupRoleWhat they receive
Less frail older patient-caregiver dyadspatients 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 dyadspatients 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.

  1. 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)
  1. 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

  2. Number of hospitalizations or unscheduled healthcare visits

    Measured: 6 month

  3. Reason of hospitalizations or unscheduled healthcare visits

    Measured: 6 month

  4. Caregiver burden assessed using the Mini-Zarit Burden Interview

    Measured: at inclusion

  5. Correlation between caregiver burden, assessed using the Mini-Zarit Burden Interview, and caregiver quality of life, assessed using the CarGOQoL scale

    Measured: at inclusion

  6. Patient living situation

    Number of patients living in institutions

    Measured: at 6 month

  7. 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.

  1. First posted15 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

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.

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