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NCT Number: NCT04617678

A Comprehensive Approach to Head and Neck Cancer Prehabilitation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanford Health, Fargo, North Dakota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation program

Other

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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Collaborators

  • University of North Dakota

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2020
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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