Quality of Life of Caregivers Supporting an Older Adult With Cancer

NCT07704073 | Not Yet Recruiting

• 2 other identifiers: APHP2602202026-A00396-45
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Caregiver Quality of Life; Geriatric Oncology; Geriatric Medicine

Keywords

CArGOQol; caregiver; oncology; geriatric

Outcome Measures

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

  at inclusion

Secondary Outcomes (7)

• To identify patient-related factors from the comprehensive geriatric assessment independently associated with poorer caregiver quality of life

  at inclusion

• Number of hospitalizations or unscheduled healthcare visits

  6 month

• Reason of hospitalizations or unscheduled healthcare visits

  6 month

• Caregiver burden assessed using the Mini-Zarit Burden Interview

  at inclusion

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

  at inclusion

Study Arms (2)

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

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

Other: CarGOQol scale

Interventions

CarGOQol scale OTHER

caregiver quality of life, assessed using the CarGOQoL scale

Less frail older patient-caregiver dyads; most frail older patients-caregiver dyads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• \- 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.

You may not qualify if:

• 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
• Caregiver:
• Unable to understand or complete study questionnaires in French.
• Clinically significant cognitive impairment identified during the consultation.
• Objection to participation.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Bretonneau

Paris, 75018, France

Location

Hôpital Saint Louis

Paris, 758010, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Amelie Aregui, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelie Aregui, MS

CONTACT

01 53 11 17 72; amelie.aregui@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

FR (2)