A Study Comparing Geriatric Co-Management With Geriatric Guided Supportive Care in Older Patients Receiving Chemoradiation Therapy for Their Head and Neck Cancer

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-03

Study Completion Date

2026-01-05

Brief Summary

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The researchers are doing this study to see whether geriatric co-management or geriatric guided supportive care are good approaches for managing side effects in older patients who have head and neck cancer and are receiving chemoradiation therapy. This study will provide valuable information about different ways to manage side effects in older patients receiving chemoradiation therapy.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study design is a randomized pilot clinical trial with two arms. Enrolled patients are those aged ≥70 years with newly diagnosed or post-operative head and neck squamous cell carcinoma. Patients will be undergoing radiation with concurrent chemotherapy.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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geriatric co-management

Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy. Consultation with geriatricians can occur in-person or remotely via telemedicine. During this visit, the geriatrician will review the results of the eRFA and create a plan to manage geriatric deficits. Geriatric co-management involves optimization of comorbid conditions, management of polypharmacy, and supportive care referrals to address geriatric deficits. Geriatricians also work in conjunction with the treating oncologists to ensure patients have appropriate pain management and bowel regimens. Additional follow up visits after the initial consultation are at the discretion of the geriatrician may vary between patients depending on the clinical need.

Group Type EXPERIMENTAL

geriatric co-management

Intervention Type OTHER

Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy.

geriatric guided supportive care

Geriatric guided supportive care will be carried out by oncologists. After the patient completes the eRFA, an automated report is generated that identifies the patient's geriatric deficits. The automated report also includes suggested interventions for each deficit (e.g, referral to physical therapy. For instance, automated suggestions for a patient with a history of falls include consultation with physical therapy, neurologic evaluation, a home safety evaluation, or use of supportive devices. Automated recommendations for patient with high level of distress or depression include referral to psychiatry or social work, involvement in a cancer support group, or additional time spent addressing questions and fears. The oncology team will review the automated report from the eRFA and create an intervention plan prior to initiation of head and neck radiation and chemotherapy.

Group Type EXPERIMENTAL

geriatric guided supportive care

Intervention Type OTHER

Geriatric guided supportive care will be carried out by oncologists. After the patient completes the eRFA, an automated report is generated that identifies the patient's geriatric deficits.

Interventions

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geriatric co-management

Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy.

Intervention Type OTHER

geriatric guided supportive care

Geriatric guided supportive care will be carried out by oncologists. After the patient completes the eRFA, an automated report is generated that identifies the patient's geriatric deficits.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 65
* Pathologically (histologically or cytologically) diagnosis of head and neck cancer of oral cavity, oropharynx, larynx, or hypopharynx
* Patient will receive a 6 to 7 week course of intensity modulated radiation therapy and concurrent chemotherapy either in definitive or post-operative setting
* Able to read and understand English
* Able to provide informed consent

Exclusion Criteria

* Patients who have previously consulted with or are followed by a geriatrician
* Inability to use telemedicine if unable to present to clinic visits in person
* Inability to complete the eRFA (patient is unable to comprehend or answer questions included on the eRFA)
* Treatment with proton therapy
* Patients on therapeutic clinical trials of experimental therapies or those not receiving standard of care

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No