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

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Arya Amini
626-218-2247
Arya Amini (PRINCIPAL_INVESTIGATOR)

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