Quality of Life of Caregivers Supporting an Older Adult With Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants will consist of patient-caregiver dyads, including patients aged 70 years or older with histologically confirmed cancer and their primary informal caregiver.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CarGOQol scale
Other interventioncaregiver quality of life, assessed using the CarGOQoL scale
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Less frail older patient-caregiver dyads1 intervention
Group B: most frail older patients-caregiver dyads1 intervention
Trial outcomes
Primary outcomes
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
Time frame
at inclusionSecondary outcomes
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.
Time frame
at inclusion2
Number of hospitalizations or unscheduled healthcare visits
Time frame
6 month3
Reason of hospitalizations or unscheduled healthcare visits
Time frame
6 month4
Caregiver burden assessed using the Mini-Zarit Burden Interview
Time frame
at inclusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: