Geriatric-guided supportive care for older adults receiving chemotherapy and radiation for head and neck cancer and their caregivers
Geriatric Assessment and Management for Older Adults Undergoing Radiation Therapy for Head and Neck Cancer and Their Family Caregivers
This project tests whether using a geriatric assessment to guide supportive care helps people aged 60+ getting chemotherapy and radiation for localized head and neck cancer and their family caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07225855 on ClinicalTrials.gov |
What this trial studies
In this randomized trial, patients 60 and older with localized, non-metastatic head and neck cancer are assigned to either a geriatric assessment (GA)-driven intervention or usual care, with caregivers randomized to the same arm as their patient. The GA arm receives structured assessments at baseline, four weeks, and one month after treatment completion, with results shared with treating oncologists and referrals to supportive services as needed; caregivers may also receive referrals. Outcomes include treatment-related toxicities, feasibility and acceptability of the intervention, patient and caregiver-reported outcomes, and health care utilization such as unplanned readmissions and ER/urgent care visits. Patients are followed at one and three months after completing the intervention period.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults age 60 or older with localized, non-metastatic head and neck cancer scheduled for curative-intent radiation with or without concurrent chemotherapy who can complete the geriatric screening, and their identified family caregivers who can also participate.
Not a fit: Patients with metastatic disease, those not receiving curative-intent radiation/chemotherapy, individuals unable to complete the geriatric screening, or non-English speakers are unlikely to benefit from this intervention as designed.
Why it matters
Potential benefit: If successful, tailoring supportive care based on geriatric assessment could reduce treatment-related side effects and improve functional and caregiver outcomes.
How similar studies have performed: Geriatric assessment–guided interventions in older oncology populations have shown promise for identifying risks and reducing toxicity or treatment modifications, but evidence specifically focused on head and neck cancer and caregiver outcomes is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PATIENT: Documented written informed consent of the participant * PATIENT: Diagnosis of non-metastatic head and neck cancer * PATIENT: Age: ≥ 60 years * PATIENT: Patient must be scheduled to undergo curative-intent, definitive radiation with or without concurrent chemotherapy or postoperative radiation with or without concurrent chemotherapy * PATIENT: Patients must have at least one geriatric assessment as assessed by the modified Geriatric 8 (G8) tool * PATIENT: Family caregivers (FCGs) are highly encouraged to participate but this is not required. Patients without FCGs will be eligible to participate in the study. FCGs will be randomized to the same arm as their corresponding patients * PATIENT: Ability to read and understand English * CAREGIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care * CAREGIVER: Ability to read and understand English * CAREGIVER: Age 18 years or older
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Arya Amini — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.