Recruiting

GA-based Management

Sponsor:

City of Hope Medical Center

Code:

NCT07225855

Conditions

Localized Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Electronic Health Record Review

Health Communication

Interview

Office Visit

Study Details

Brief 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.

Conditions

Localized Head and Neck Carcinoma

Study ID

NCT07225855

Start date

Oct 1, 2026

Status verified date

Aug, 2026

Completion date

Nov 24, 2027

Anticipated

Primary completion date

Nov 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Best Practice

Receive usual care

Electronic Health Record Review

Ancillary studies

Health Communication

Shared with treating oncology

Interview

Ancillary studies

Office Visit

Attend regular clinical visits

Practical Geriatric Assessment

Undergo PGA

Questionnaire Administration

Ancillary studies

Referral

Receive referrals to resources and programs

Referral

Receive referrals to supportive care services

Supportive Care

Receive referrals to supportive care services

Primary outcome measure

  • Proportion of grade 2-5 non-hematologic treatment-related toxicities [ Time Frame: Up to 3 months after completion of treatment ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Arya Amini

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-21.