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NCT04617678 · ClinicalTrials.gov registry record · NA
A Comprehensive Approach to Head and Neck Cancer Prehabilitation
A NA study of Cancer of Head and Neck, sponsored by Sanford Health.
- Active
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT04617678: Active NA study of Cancer of Head and Neck, sponsored by Sanford Health.
NCT04617678 is a NA study of Cancer of Head and Neck that is active but no longer recruiting, run by Sanford Health. The registered enrollment target is 80 participants, below the 240-participant average among 9 other Cancer of Head and Neck trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04617678, a NA study of Cancer of Head and Neck, is active but no longer recruiting, sponsored by Sanford Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Prehabilitation Program
Study Locations (2)
North Dakota
- Sanford Health - Fargo
South Dakota
- Sanford Health - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT04617678 still lists
NCT04617678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 240-participant average among 9 other Cancer of Head and Neck trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Cancer of Head and Neck appearing as the primary indexed condition, and to 1 intervention - of which Prehabilitation Program is the first listed.
NCT04617678 reports a single indexed study location in North Dakota, South Dakota.
Frequently Asked Questions
What is clinical trial NCT04617678 about?
NCT04617678 is a clinical study titled "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...
What is the current status of trial NCT04617678?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-10-21. Estimated completion is 2026-12.
What conditions does trial NCT04617678 study?
This clinical trial studies the following conditions: Cancer of Head and Neck.
What interventions are being tested in trial NCT04617678?
The interventions under investigation include: Prehabilitation Program (OTHER).
Who is sponsoring clinical trial NCT04617678?
This trial is sponsored by Sanford Health, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04617678 being conducted?
This trial has 2 study locations across North Dakota, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer of Head and Neck
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04617678's enrollment target sits among peer trials
80 4th of 9 higher than 6 of 9 other Cancer of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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