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A Comprehensive Approach to Head and Neck Cancer Prehabilitation

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Sanford Health

Status

Active, not recruiting

Conditions

Cancer of Head and Neck

Treatments

Other: Prehabilitation Program

Study type

Interventional

Funder types

Other

Identifiers

NCT04617678
CTR H&N Cancer Prehab

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

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

Trial contacts and locations

2

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Central trial contact

Amy Schmidt, RN

Data sourced from clinicaltrials.gov

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