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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
Sanford Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Head and Neck

Eligibility Criteria

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

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

First Posted
October 23, 2020
Last Updated
October 19, 2023
Sponsor
Sanford Health
Collaborators
University of North Dakota
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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

Citations:
PubMed Identifier
30919154
Citation
Samuel SR, Maiya AG, Fernandes DJ, Guddattu V, Saxena PUP, Kurian JR, Lin PJ, Mustian KM. Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy. Support Care Cancer. 2019 Oct;27(10):3913-3920. doi: 10.1007/s00520-019-04750-z. Epub 2019 Mar 27.
Results Reference
background
Citation
Stenson, K. M. (2019). Epidemiology and risk factors for head and neck cancer. UpToDate. Retrieved, November 15, 2019 from https://www.uptodate.com/contents/epidemiology-and-risk-factors-for-head-and-neck-cancer.
Results Reference
background
PubMed Identifier
30335190
Citation
Osazuwa-Peters N, Simpson MC, Zhao L, Boakye EA, Olomukoro SI, Deshields T, Loux TM, Varvares MA, Schootman M. Suicide risk among cancer survivors: Head and neck versus other cancers. Cancer. 2018 Oct 15;124(20):4072-4079. doi: 10.1002/cncr.31675. Epub 2018 Oct 18.
Results Reference
background
PubMed Identifier
31269918
Citation
Beck ACC, Passchier E, Retel VP, Stuiver MM, van der Molen L, Klop WMC, Navran A, van Harten WH, van den Brekel MWM. Study protocol of a prospective multicenter study comparing (cost-)effectiveness of a tailored interdisciplinary head and neck rehabilitation program to usual supportive care for patients treated with concomitant chemo- or bioradiotherapy. BMC Cancer. 2019 Jul 3;19(1):655. doi: 10.1186/s12885-019-5874-z.
Results Reference
background
PubMed Identifier
31185387
Citation
Jung AR, Roh JL, Kim JS, Kim SB, Choi SH, Nam SY, Kim SY. Prognostic value of body composition on recurrence and survival of advanced-stage head and neck cancer. Eur J Cancer. 2019 Jul;116:98-106. doi: 10.1016/j.ejca.2019.05.006. Epub 2019 Jun 10.
Results Reference
background
PubMed Identifier
31380686
Citation
Barrett-Bernstein M, Carli F, Gamsa A, Scheede-Bergdahl C, Minnella E, Ramanakumar AV, Tourian L. Depression and functional status in colorectal cancer patients awaiting surgery: Impact of a multimodal prehabilitation program. Health Psychol. 2019 Oct;38(10):900-909. doi: 10.1037/hea0000781. Epub 2019 Aug 5.
Results Reference
background
PubMed Identifier
11448365
Citation
Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6.
Results Reference
background
PubMed Identifier
8615964
Citation
D'Antonio LL, Zimmerman GJ, Cella DF, Long SA. Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1996 May;122(5):482-7. doi: 10.1001/archotol.1996.01890170018005.
Results Reference
background
PubMed Identifier
8635098
Citation
List MA, D'Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E. The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer. 1996 Jun 1;77(11):2294-301. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-S.
Results Reference
background
PubMed Identifier
30193337
Citation
Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
Results Reference
background
PubMed Identifier
28821385
Citation
Mordarski BA, Hand RK, Wolff J, Steiber AL. Increased Knowledge, Self-Reported Comfort, and Malnutrition Diagnosis and Reimbursement as a Result of the Nutrition-Focused Physical Exam Hands-On Training Workshop. J Acad Nutr Diet. 2017 Nov;117(11):1822-1828. doi: 10.1016/j.jand.2017.06.362. Epub 2017 Aug 16. No abstract available.
Results Reference
background
PubMed Identifier
22193671
Citation
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
Results Reference
background
PubMed Identifier
30846324
Citation
Sealy MJ, Dechaphunkul T, van der Schans CP, Krijnen WP, Roodenburg JLN, Walker J, Jager-Wittenaar H, Baracos VE. Low muscle mass is associated with early termination of chemotherapy related to toxicity in patients with head and neck cancer. Clin Nutr. 2020 Feb;39(2):501-509. doi: 10.1016/j.clnu.2019.02.029. Epub 2019 Feb 22.
Results Reference
background
PubMed Identifier
24078216
Citation
Wall LR, Ward EC, Cartmill B, Hill AJ. Physiological changes to the swallowing mechanism following (chemo)radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2013 Dec;28(4):481-493. doi: 10.1007/s00455-013-9491-8.
Results Reference
background

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A Comprehensive Approach to Head and Neck Cancer Prehabilitation

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