Clinical trial NCT05239000: A Study Comparing Geriatric Co-Management With Geriatric Guided Supportive Care in Older Patients Receiving Chemoradiation Therapy for Their Head and Neck Cancer
Official title: Pilot Randomized Clinical Trial of Geriatric Comanagement or Geriatric Guided Supportive Care for Older Patients With Head and Neck Cancer Receiving Radiation and Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Supportive Care
Older Patients with Head and Neck Cancer Receiving Radiation and Chemotherapy
22-016
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients with hospital admission (geriatric co-management arm)
timeFrame: 2 years
measure: proportion of patients with hospital admission (geriatric guided supportive care arm)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: