A Comprehensive Approach to Head and Neck Cancer Prehabilitation
Primary Purpose
Cancer of Head and Neck
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation Program
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Head and Neck
Eligibility Criteria
Inclusion Criteria:
- Equal to or greater than 18 years of age
- Diagnosis of head and neck cancer
- Actively pursuing cancer treatment with a curative intent
- Willing and able to provide written consent
Exclusion Criteria:
- Patients with cardiac arrhythmia with implanted pacemaker
- Patients with other implanted electronic equipment/device
- Patients undergoing external defibrillation
- Pregnant women (per BIS instructions for use, pregnant women should not participate)
- Patient weight exceeding 375 lbs.
- Patient has a metal allergy
Sites / Locations
- Sanford Health
- Sanford Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prospective Prehabilitation
Prospective Control
Arm Description
Prospectively enrolling patients into a prehabilitation program for head and neck cancer.
Prospectively enrolling patients to a control arm with no intervention.
Outcomes
Primary Outcome Measures
Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
The Behavioral Health Screening 6 (BHS-6) is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, self-report instrument assessing suicidality. Higher scores indicate greater suicidality. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the MDADI to after treatment.
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
The FACT-H&N (Version 4) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Secondary Outcome Measures
Impact of sarcopenia on functioning
Sarcopenia will be measured using bioimpedence spectroscopy technology (BIS), a validated noninvasive measure of volume of fluids in various parts of the body. Functional assessments (sit to stand, grip strength, and two-minute walk test) will be tested as possible predictors of sarcopenia.
Difference between treatment and control group on sarcopenia measures
Sarcopenia measures collected via computed tomography will be used to compare patients who completed the prehabilitation program and those who have not.
Change from baseline to after treatment on the BHS-6.
The Behavioral Health Screening 6 (BHS-6) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the C-SSRS.
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the NCCN Distress Thermometer.
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the 2-min walk test.
The 2-min walk test is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the 30 seconds sit to stand.
The 30 seconds sit to stand is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the grip strength.
The grip strength is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the NFPE.
The Nutrition Focused Physical Exam (NFPE) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the MDADI.
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the BIS.
The Bioelectic impedance spectroscopy (BIS) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Change from baseline to after treatment on the FACT-H&N (Version 4).
The FACT-H&N (Version 4) is a validated, self-report instrument of functional assessments of overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).
Full Information
NCT ID
NCT04617678
First Posted
October 23, 2020
Last Updated
October 19, 2023
Sponsor
Sanford Health
Collaborators
University of North Dakota
1. Study Identification
Unique Protocol Identification Number
NCT04617678
Brief Title
A Comprehensive Approach to Head and Neck Cancer Prehabilitation
Official Title
A Comprehensive Approach to Head and Neck Cancer Prehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanford Health
Collaborators
University of North Dakota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, "swallowing, speech, breathing, and cancer-related fatigue". Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, "compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide". In view of the aforementioned research, Roger Maris Cancer Center's head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized prospective two-arm clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prospective Prehabilitation
Arm Type
Active Comparator
Arm Description
Prospectively enrolling patients into a prehabilitation program for head and neck cancer.
Arm Title
Prospective Control
Arm Type
No Intervention
Arm Description
Prospectively enrolling patients to a control arm with no intervention.
Intervention Type
Other
Intervention Name(s)
Prehabilitation Program
Intervention Description
We will assess whether prehabilitation intervention helps mitigate adverse symptoms (e.g., anxiety, depression, suicidality, distress, nutritional status, dysphagia, sarcopenia, and well-being) on a sample of head and neck cancer patients. Subjects will attend a Prepare for Surgery Heal Faster session and meet with a physical therapist, registered dietician, speech language pathologist, and masters of social work at pre-treatment, 6-8 weeks post-treatment, and 5-6 months post-treatment completion.
Primary Outcome Measure Information:
Title
Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
Description
The Behavioral Health Screening 6 (BHS-6) is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Title
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
Description
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, self-report instrument assessing suicidality. Higher scores indicate greater suicidality. Difference = (Treatment score - Control score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Title
Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
Description
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Title
Difference between treatment and control group, from baseline in the MDADI to after treatment.
Description
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Title
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
Description
The FACT-H&N (Version 4) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Secondary Outcome Measure Information:
Title
Impact of sarcopenia on functioning
Description
Sarcopenia will be measured using bioimpedence spectroscopy technology (BIS), a validated noninvasive measure of volume of fluids in various parts of the body. Functional assessments (sit to stand, grip strength, and two-minute walk test) will be tested as possible predictors of sarcopenia.
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months
Title
Difference between treatment and control group on sarcopenia measures
Description
Sarcopenia measures collected via computed tomography will be used to compare patients who completed the prehabilitation program and those who have not.
Time Frame
Post-treatment, ranging from 2 weeks to 6 months
Title
Change from baseline to after treatment on the BHS-6.
Description
The Behavioral Health Screening 6 (BHS-6) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the C-SSRS.
Description
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the NCCN Distress Thermometer.
Description
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the 2-min walk test.
Description
The 2-min walk test is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the 30 seconds sit to stand.
Description
The 30 seconds sit to stand is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the grip strength.
Description
The grip strength is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the NFPE.
Description
The Nutrition Focused Physical Exam (NFPE) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the MDADI.
Description
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the BIS.
Description
The Bioelectic impedance spectroscopy (BIS) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Title
Change from baseline to after treatment on the FACT-H&N (Version 4).
Description
The FACT-H&N (Version 4) is a validated, self-report instrument of functional assessments of overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).
Time Frame
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Equal to or greater than 18 years of age
Diagnosis of head and neck cancer
Actively pursuing cancer treatment with a curative intent
Willing and able to provide written consent
Exclusion Criteria:
Patients with cardiac arrhythmia with implanted pacemaker
Patients with other implanted electronic equipment/device
Patients undergoing external defibrillation
Pregnant women (per BIS instructions for use, pregnant women should not participate)
Patient weight exceeding 375 lbs.
Patient has a metal allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Hysjulien, PsyD
Organizational Affiliation
Sanford Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
12. IPD Sharing Statement
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30919154
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A Comprehensive Approach to Head and Neck Cancer Prehabilitation
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