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

NCT ID: NCT07225855

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-09

Study Completion Date

2027-11-24

Brief Summary

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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

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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.

Conditions

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Localized Head and Neck Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Health Communication

Intervention Type BEHAVIORAL

Shared with treating oncology

Interview

Intervention Type OTHER

Ancillary studies

Practical Geriatric Assessment

Intervention Type OTHER

Undergo PGA

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Referral

Intervention Type OTHER

Receive referrals to resources and programs

Supportive Care

Intervention Type OTHER

Receive referrals to supportive care services

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Office Visit

Intervention Type OTHER

Attend regular clinical visits

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Referral

Intervention Type OTHER

Receive referrals to supportive care services

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Health Communication

Shared with treating oncology

Intervention Type BEHAVIORAL

Interview

Ancillary studies

Intervention Type OTHER

Office Visit

Attend regular clinical visits

Intervention Type OTHER

Practical Geriatric Assessment

Undergo PGA

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Referral

Receive referrals to resources and programs

Intervention Type OTHER

Referral

Receive referrals to supportive care services

Intervention Type OTHER

Supportive Care

Receive referrals to supportive care services

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Referred Referred Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arya Amini

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Facility Contacts

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Arya Amini

Role: primary

Other Identifiers

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NCI-2025-07662

Identifier Type: REGISTRY

Identifier Source: secondary_id

22617

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22617

Identifier Type: -

Identifier Source: org_study_id