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A Comprehensive Approach to Head and Neck Cancer Prehabilitation

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2025 to Dec 5, 2025
    v8
  2. Notable Trial status: Active, Not Recruiting to Enrolling by Invitationv7
  3. Notable Primary completion date: Aug 2024 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2026
    v6
  4. Notable Primary completion date: Aug 2023 to Aug 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2023 to Dec 2024
    • Site details revised at 2 of 2 sites
    v5
  5. Notable Primary completion date: Aug 2022 to Aug 2023
    • Study completion date: Dec 2022 to Dec 2023
    v4
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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Enrollment target: 200 to 80
    • Start date changed from estimate of May 2021 to Oct 21, 2021
    • Primary endpoints: 1 to 5
    • Study sites: 1 to 2
    • Primary completion date: Dec 2022 to Aug 2022
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints expanded, about 115 words
    • Publications: 4 to 14
  2. Minor Study Status, Outcome Measures, Referencesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04617678
Lead Sponsor Sanford Health
Collaborators: University of North Dakota
Conditions
(from sponsor)
Cancer of Head and Neck
Related terms Head and Neck Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov