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

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
geriatric co-management
geriatric guided supportive care
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Supportive Care, Older Patients with Head and Neck Cancer Receiving Radiation and Chemotherapy, 22-016

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

geriatric co-management

geriatric guided supportive care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2022
Last Updated
December 21, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05239000
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Supportive Care, Older Patients with Head and Neck Cancer Receiving Radiation and Chemotherapy, 22-016

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
geriatric co-management
Arm Type
Experimental
Arm Description
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.
Arm Title
geriatric guided supportive care
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
geriatric co-management
Intervention Description
Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy.
Intervention Type
Other
Intervention Name(s)
geriatric guided supportive care
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of patients with hospital admission (geriatric co-management arm)
Description
The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm.
Time Frame
2 years
Title
proportion of patients with hospital admission (geriatric guided supportive care arm)
Description
The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Email
zakerik@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Lee, MD
Phone
212-639-3341
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Facility Name
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Phone
212-639-3341
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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