What this study is
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.
What's being tested
- Best Practice
Intervention · OTHER
Receive usual care
- Electronic Health Record Review
Intervention · OTHER
- Health Communication
Intervention · BEHAVIORAL
Shared with treating oncology
- Interview
Intervention · OTHER
- Office Visit
Intervention · OTHER
Attend regular clinical visits
- Practical Geriatric Assessment
Intervention · OTHER
Undergo PGA
- Questionnaire Administration
Intervention · OTHER
- Referral
Intervention · OTHER
Receive referrals to resources and programs
- Referral
Intervention · OTHER
- Supportive Care
Intervention · OTHER
All of Electronic Health Record Review, Interview, Questionnaire Administration
Ancillary studies
Both Referral and Supportive Care
Receive referrals to supportive care services
Study details
- Official title
- Geriatric Assessment and Management for Older Adults Undergoing Radiation Therapy for Head and Neck Cancer and Their Family Caregivers
- Sponsor
- City of Hope Medical Center
- Conditions
- Localized Head and Neck Carcinoma
- Enrolling
- 36 people
- Starts
- 2026-08-25
- Est. completion
- 2029-03-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCity of Hope Medical Center
Duarte, California, United States
- Arya Amini · Contact626-218-2247aamini@coh.org
- Arya Amini · Principal investigator
Recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 22617
Principal investigator
Arya Amini
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.