A Comprehensive Approach to Head and Neck Cancer Prehabilitation

October 19, 2023 updated by: Sanford Health
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Sanford Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prospective Prehabilitation
Prospectively enrolling patients into a prehabilitation program for head and neck cancer.
Other: Prehabilitation Program
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.
No Intervention: Prospective Control
Prospectively enrolling patients to a control arm with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the MDADI to after treatment.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of sarcopenia on functioning
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months
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.
Baseline; post-treatment, ranging from 2 weeks to 6 months
Difference between treatment and control group on sarcopenia measures
Time Frame: Post-treatment, ranging from 2 weeks to 6 months
Sarcopenia measures collected via computed tomography will be used to compare patients who completed the prehabilitation program and those who have not.
Post-treatment, ranging from 2 weeks to 6 months
Change from baseline to after treatment on the BHS-6.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the C-SSRS.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the NCCN Distress Thermometer.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the 2-min walk test.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
The 2-min walk test is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the 30 seconds sit to stand.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
The 30 seconds sit to stand is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the grip strength.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
The grip strength is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the NFPE.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
The Nutrition Focused Physical Exam (NFPE) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the MDADI.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the BIS.
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
The Bioelectic impedance spectroscopy (BIS) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the FACT-H&N (Version 4).
Time Frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
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).
Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Collaborators

University of North Dakota

Investigators

  • Principal Investigator: Cheryl Hysjulien, PsyD, Sanford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTR H&N Cancer Prehab

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer of Head and Neck

Clinical Trials on Prehabilitation Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe