Localized Head and Neck CarcinomaNCT07225855
Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer and Their Family Caregivers
A study testing Best Practice, Electronic Health Record Review and Health Communication in people with Localized Head and Neck Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Localized Head and Neck Carcinoma
- What is being tested?
- Best Practice, Electronic Health Record Review and Health Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Arya Amini, 626-218-2247, aamini@coh.org
Arya Amini
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety of the intervention by evaluation of treatment-related toxicities.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Localized Head and Neck Carcinoma
- Being tested
- Best Practice, Electronic Health Record Review, Health Communication, Interview, Office Visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Electronic Health Record ReviewOther
Ancillary studies
Health CommunicationBehavioural
Shared with treating oncology
InterviewOther
Ancillary studies
Office VisitOther
Attend regular clinical visits
Practical Geriatric AssessmentOther
Undergo PGA
Questionnaire AdministrationOther
Ancillary studies
ReferralOther
Also called Referred
Receive referrals to resources and programs
ReferralOther
Also called Referred
Receive referrals to supportive care services
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive referrals to supportive care services
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Electronic Health Record Review; Other: Office Visit; Other: Questionnaire Administration; Other: Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months after completion of treatment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start25 Aug 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arya Amini, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225855
- Sponsor's protocol ID
- 22617
- Other IDs
- NCI-2025-07662, 22617, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment and Management for Older Adults Undergoing Radiation Therapy for Head and Neck Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT07225855
- Acronym / sponsor ID
- 22617
- Conditions
- Localized Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety of the intervention by evaluation of treatment-related toxicities.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (GA-driven intervention) | Experimental | Other: Electronic Health Record Review, Behavioral: Health Communication, Other: Interview, Other: Practical Geriatric Assessment, Other: Questionnaire Administration, Other: Referral, Other: Supportive CarePatients 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) | Active comparator | Other: Best Practice, Other: Electronic Health Record Review, Other: Office Visit, Other: Questionnaire Administration, Other: ReferralPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm B (usual care) |
| Electronic Health Record ReviewAncillary studies | Other | Arm A (GA-driven intervention), Arm B (usual care) |
| Health CommunicationShared with treating oncology | Behavioural | Arm A (GA-driven intervention) |
| InterviewAncillary studies | Other | Arm A (GA-driven intervention) |
| Office VisitAttend regular clinical visits | Other | Arm B (usual care) |
| Practical Geriatric AssessmentUndergo PGA | Other | Arm A (GA-driven intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (GA-driven intervention), Arm B (usual care) |
| ReferralAlso: ReferredReceive referrals to resources and programs | Other | Arm A (GA-driven intervention) |
| ReferralAlso: ReferredReceive referrals to supportive care services | Other | Arm B (usual care) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive referrals to supportive care services | Other | Arm A (GA-driven intervention) |
Primary outcome
Proportion of grade 2-5 non-hematologic treatment-related toxicities
Time frame: Up to 3 months after completion of treatment
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.
7 secondary outcomes
Percentage of eligible participants who enroll in the study
Time frame: Up to 1 year
Retention rate
Time frame: Up to 3 months after completion of study treatment
Acceptability of the intervention
Time frame: Up to 3 months after completion of treatment
Proportion of any-grade non-hematologic treatment-related toxicities
Time frame: Up to 3 months after completion of treatment
Patient/family caregiver self-reported outcomes
Time frame: Up to 3 months after completion of treatment
Rate of unplanned readmissions
Time frame: Up to 3 months after completion of treatment
Rate of emergency room/urgent care visits
Time frame: Up to 3 months after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Localized Head and Neck Carcinoma
RecruitingPhase 4
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma
Active, not recruitingObservational study
People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity
HIV Infections, Oral Squamous Cell Carcinoma
RecruitingObservational study
The Impact of Surgical Treatment on Survival in Localized Small Cell Esophageal Cancer
Esophageal Carcinoma, Limited-Stage Small Cell Esophageal Carcinoma
Active, not recruitingPhase 2
Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN
Head and Neck Cancer
Recruiting
Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study
Thyroid Papillary Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arya Amini principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Electronic Health Record Review and Health Communication in people with Localized Head and Neck Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of grade 2-5 non-hematologic treatment-related toxicities (time frame: Up to 3 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.