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

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.

Study Overview

• Status: Recruiting
• Conditions: Localized Head and Neck Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Interview; Other: Electronic Health Record Review; Behavioral: Health Communication; Other: Practical Geriatric Assessment; Other: Referral; Other: Referral; Other: Supportive Care; Other: Office Visit

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Principal Investigator: Arya Amini
      • Contact: Arya Amini; Phone Number: 626-218-2247; Email: aamini@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Behavioral: Health Communication; Shared with treating oncology; Other: Practical Geriatric Assessment; Undergo PGA; Other: Referral; Receive referrals to resources and programs; Other Names: Referred; Other: Referral; Receive referrals to supportive care services; Other Names: Referred; Other: Supportive Care; Receive referrals to supportive care services; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive
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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Electronic Health Record Review; Ancillary studies; Other: Referral; Receive referrals to resources and programs; Other Names: Referred; Other: Referral; Receive referrals to supportive care services; Other Names: Referred; Other: Office Visit; Attend regular clinical visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eligible participants who enroll in the study	The denominator will be all patients who meet eligibility criteria and are approached for consent. The numerator will be those who provide consent and are successfully randomized. The feasibility threshold will be met if ≥ 60% of eligible patients enroll and are randomized. Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval.	Up to 1 year
Retention rate	Will be defined as the percentage of participants in the intervention arm who complete the Practical Geriatric Assessment (PGA) tool. The denominator will be all patients randomized to the intervention arm. The retention threshold will be met if ≥ 60% of these participants complete the PGA tool. Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval.	Up to 3 months after completion of study treatment
Acceptability of the intervention	Will be defined as the percentage of participants in the intervention arm who are referred to and seen by supportive care services. The denominator will be all patients in the intervention arm who receive geriatric assessment-guided recommendations for supportive care referrals. The acceptability threshold will be met if ≥ 60% of these participants agree to and are seen by at least one recommended service during the study period. Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints.	Up to 3 months after completion of treatment
Proportion of any-grade non-hematologic treatment-related toxicities	Will be assessed in patients using CTCAE 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
Patient/family caregiver self-reported outcomes	Will be assessed using the geriatric assessment, Functional Assessment of Cancer Therapy-Head and Neck questionnaire, distress thermometer, Montgomery Borgatta Caregiver Burden Scale, and satisfaction with communication. 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. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints.	Up to 3 months after completion of treatment
Rate of unplanned readmissions	Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints.	Up to 3 months after completion of treatment
Rate of emergency room/urgent care visits	Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints.	Up to 3 months after completion of treatment

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Arya Amini, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): November 24, 2027

Study Registration Dates

• First Submitted: November 5, 2025
• First Submitted That Met QC Criteria: November 5, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Professional Practice; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Guidelines as Topic; Quality Assurance, Health Care; Interviews as Topic; Standard of Care; Palliative Care; Referral and Consultation; Practice Guidelines as Topic; Health Communication; Office Visits
• Other Study ID Numbers: 22617 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2025-07662 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No