Clinical Trial

A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Active, Not Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-10-30; most recent amendment 2026-01-14.
Status change: Enrolling by Invitation → Active, Not Recruiting 2026-01-14
Status change: Active, Not Recruiting → Enrolling by Invitation 2025-01-19
Status change: Recruiting → Active, Not Recruiting 2023-10-19
Status change: Not Yet Recruiting → Recruiting 2021-11-24
Trial Details
NCT Number NCT04617678
Lead Sponsor Sanford Health
Collaborators: University of North Dakota
Conditions Cancer of Head and Neck
Enrollment 80 participants
Start Date 2021-10-21
Primary Completion 2025-12-05 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-16