Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer and Their Family Caregivers
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT07225855
- Status
- Recruiting
Conditions
- Localized Head and Neck Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Best Practice — OTHERReceive usual care
- Electronic Health Record Review — OTHERAncillary studies
- Health Communication — BEHAVIORALShared with treating oncology
- Interview — OTHERAncillary studies
- Office Visit — OTHERAttend regular clinical visits
- Practical Geriatric Assessment — OTHERUndergo PGA
- Questionnaire Administration — OTHERAncillary studies
- Referral — OTHERReceive referrals to resources and programs
- Referral — OTHERReceive referrals to supportive care services
- Supportive Care — OTHERReceive referrals to supportive care services
Study Details
This clinical trial compares the effect of geriatric assessment (GA)-based management of supportive care to usual care in treating older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their family caregivers (FCG). At least one quarter of head and neck cancers patients are diagnosed at age 70 or older. Treatment for head and neck cancers usually include surgery, chemotherapy, and radiation. Older adults are often at higher risk for functional problems, and may experience more side effects. In addition, there may be a lack of support mechanisms in place to address the needs of these older patients. Cancer not only affects the patients but the entire family, especially the family member who is the caregiver. Currently, all patients over 65 receive the same standard of care based on national guidelines, which include supportive care referrals. However, data suggests, that many patients may need more frequent and structured support. The Practical Geriatric Assessment (PGA) is a complete examination including evaluation of the physical and mental function as well as the emotional state of the older patient. PGA-based supportive care interventions may be safe, tolerable, and/or effective in managing treatment-related side effects and improving quality of life compared to usual care in older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their FCG.
Key Dates
- Start date
- Jul 9, 2026
- Status verified
- May 2026
- Primary completion
- Nov 24, 2027
- Completion
- Nov 24, 2027
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm A (GA-driven intervention)Patients undergo PGA at baseline, at 4 weeks and at 1 month after completing treatment. Assessment results shared with treating oncologists and patients receive referrals to supportive care services for the problems identified with the assessment throughout the study. Caregivers may receive referrals to resources and programs.
- Active Comparator: Arm B (usual care)Patients attend regular clinical visits for treatment and follow up and receive usual care provided by their radiation oncology and medical oncology teams and referrals to supportive care services as needed throughout the study.
Primary Outcome Measure
Proportion of grade 2-5 non-hematologic treatment-related toxicities [ Time Frame: Up to 3 months after completion of treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Arya Amini (PRINCIPAL_INVESTIGATOR) |
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