~11 spots leftby Dec 2025

Prehabilitation Program for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)
+1 other location
CH
Overseen byCheryl Hysjulien, PsyD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Sanford Health
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

CH

Cheryl Hysjulien, PsyD

Principal Investigator

Sanford Health

Eligibility Criteria

This trial is for adults over 18 with a diagnosis of head and neck cancer who are seeking treatment aimed at curing their disease. They must be able to consent to participate. It's not open to those over 375 lbs, with metal allergies, certain heart conditions, pregnant women, or individuals with implanted electronic devices.

Inclusion Criteria

Willing and able to provide written consent
I am 18 years old or older.
I am currently seeking treatment to cure my cancer.
See 1 more

Exclusion Criteria

You are currently receiving treatment with an external defibrillator.
Pregnant women (per BIS instructions for use, pregnant women should not participate)
Patient weight exceeding 375 lbs.
See 3 more

Treatment Details

Interventions

  • Prehabilitation Program (Behavioural Intervention)
Trial OverviewThe study is testing a prehabilitation program designed for patients with head and neck cancer. The program includes personalized education and interventions based on standardized screenings aiming to improve physical, social, and emotional functioning before starting rigorous treatments.
Participant Groups
2Treatment groups
Active Control
Group I: Prospective ControlActive Control1 Intervention
Prospectively enrolling patients to a control arm with no intervention.
Group II: Prospective PrehabilitationActive Control1 Intervention
Prospectively enrolling patients into a prehabilitation program for head and neck cancer.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials
53
Recruited
2,067,000+

University of North Dakota

Collaborator

Trials
17
Recruited
1,200+