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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| geriatric co-management | Experimental | 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. |
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| geriatric guided supportive care | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| geriatric co-management | Other | Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with hospital admission (geriatric co-management arm) | The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm. | 2 years |
| proportion of patients with hospital admission (geriatric guided supportive care arm) | The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Lee, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
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| geriatric guided supportive care | 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. |
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| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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