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

NCT07225855 | Not Yet Recruiting DMC

• 3 other identifiers: 22617NCI-2025-07662P30CA033572
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of grade 2-5 non-hematologic treatment-related toxicities

  Will be assessed in patients using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized using descriptive statistics. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution. Rates will be estimated along with the 95% exact binomial confidence interval.

  Up to 3 months after completion of treatment

Secondary Outcomes (7)

• Percentage of eligible participants who enroll in the study

  Up to 1 year

• Retention rate

  Up to 3 months after completion of study treatment

• Acceptability of the intervention

  Up to 3 months after completion of treatment

• Proportion of any-grade non-hematologic treatment-related toxicities

  Up to 3 months after completion of treatment

• Patient/family caregiver self-reported outcomes

  Up to 3 months after completion of treatment

Study Arms (2)

Arm A (GA-driven intervention)

EXPERIMENTAL

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.

Other: Electronic Health Record Review; Behavioral: Health Communication; Other: Interview; Other: Practical Geriatric Assessment; Other: Questionnaire Administration; Other: Referral; Other: Supportive Care

Arm B (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Electronic Health Record Review; Other: Office Visit; Other: Questionnaire Administration; Other: Referral

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm B (usual care)

Electronic Health Record Review OTHER

Ancillary studies

Arm A (GA-driven intervention); Arm B (usual care)

Health Communication BEHAVIORAL

Shared with treating oncology

Arm A (GA-driven intervention)

Interview OTHER

Ancillary studies

Arm A (GA-driven intervention)

Office Visit OTHER

Attend regular clinical visits

Arm B (usual care)

Practical Geriatric Assessment OTHER

Undergo PGA

Arm A (GA-driven intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm A (GA-driven intervention); Arm B (usual care)

Referral OTHER

Receive referrals to resources and programs

Also known as: Referred

Arm A (GA-driven intervention)

Supportive Care OTHER

Receive referrals to supportive care services

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm A (GA-driven intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Health Communication; Interviews as Topic; Office Visits; Referral and Consultation; Palliative Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Professional Practice; Organization and Administration; Patient Care; Therapeutics; Health Services

Study Officials

• Arya Amini

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): November 24, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)