NCT07225855

Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer and Their Family Caregivers

Geriatric Assessment and Management for Older Adults Undergoing Radiation Therapy for Head and Neck Cancer and Their Family Caregivers

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the safety of the intervention by evaluation of treatment-related toxicities. SECONDARY OBJECTIVES: I. To assess the feasibility, retention, and acceptability of the intervention. II. To assess the rate of any grade non-hematologic treatment-related toxicities. III. To assess patient/FCG self-reported outcomes. IV. To assess the symptom-related outcomes by evaluation of unplanned readmissions and emergency room (ER)/urgent care visits. OUTLINE: Patients are randomized to 1 of 2 arms. Caregivers are randomized to the same arm as the corresponding patients. 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. 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. After completion of study interventions, patients are followed up at 1 and 3 months.

Conditions

• Localized Head and Neck Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Electronic Health Record Review	Ancillary studies
BEHAVIORAL	Health Communication	Shared with treating oncology
OTHER	Interview	Ancillary studies
OTHER	Office Visit	Attend regular clinical visits
OTHER	Practical Geriatric Assessment	Undergo PGA
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Referral	Receive referrals to resources and programs
OTHER	Referral	Receive referrals to supportive care services
OTHER	Supportive Care	Receive referrals to supportive care services

Timeline

• Start date: 2026-07-09
• Primary completion: 2027-11-24
• Completion: 2027-11-24
• First posted: 2025-11-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States