Pilot Randomized Clinical Trial of Geriatric Comanagement or Geriatric Guided Supportive Care for Older Patients With Head and Neck Cancer Receiving Radiation and Chemotherapy
Overview
- Phase
- N/A
- Intervention
- geriatric co-management
- Conditions
- Head and Neck Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 30
- Locations
- 12
- Primary Endpoint
- proportion of patients with hospital admission (geriatric guided supportive care arm)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: geriatric co-management
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.
Intervention: geriatric guided supportive care
Outcomes
Primary Outcomes
proportion of patients with hospital admission (geriatric guided supportive care arm)
Time Frame: 2 years
The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm.
proportion of patients with hospital admission (geriatric co-management arm)
Time Frame: 2 years
The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm.