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Implementation and Effectiveness Trial of HN-STAR
NCT04208490 · View on ClinicalTrials.gov ↗
Study Summary
People who have been treated for head and neck cancer (HNC survivors) can experience serious consequences from their cancer and its treatment, ongoing risks of new cancers, and other unrelated illnesses. These concerns pose challenges to the provision of comprehensive care to HNC survivors. We created HN-STAR to facilitate and tailor the ongoing care of HNC survivors. Survivors use HN-STAR on a computer or tablet to answer questions about symptoms and health concerns before a routine visit with a cancer care provider. During the clinic visit, the provider uses HN-STAR to see evidence-based recommendations for managing each concern reported by the survivor. The provider and survivor discuss recommendations and select appropriate actions (e.g., testing, referrals, prescriptions, self-management). HN-STAR produces a survivorship care plan that includes all reported concerns and the actions selected in clinic. The survivorship care plan is given to the survivor and the primary care provider. Three months, six months, and nine months later, the survivor uses HN-STAR from home (or clinic) to report their concerns again, and a new survivorship care plan is created each time. Our trial randomizes 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 recent survivors of head and neck cancer. We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes (including cancer-related well-being, symptoms, and patient activation) over one year compared to survivors in the usual care arm, measured by surveys at baseline and one year later. We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm. Our final aim investigates the implementation of HN-STAR in clinical practice, using interviews and surveys of survivors,
Conditions Studied
Interventions
- OTHER HN-STAR Intervention
Study Locations (20)
Illinois
- John H Stroger Jr Hospital Cook County — Chicago
- Carle at The Riverfront — Danville
- Carle on Vermilion — Danville
- Decatur Memorial Hospital — Decatur
- Carle Physician Group-Mattoon/Charleston — Mattoon
- Carle Cancer Center — Urbana
Delaware
- Beebe South Coastal Health Campus — Frankford
- Beebe Health Campus — Rehoboth Beach
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
- MedStar Washington Hospital Center — Washington D.C.
Georgia
- Phoebe Putney Memorial Hospital — Albany
- Augusta University Medical Center — Augusta
Iowa
- Iowa Methodist Medical Center — Des Moines
- Mercy Medical Center - Des Moines — Des Moines
Maine
- Harold Alfond Center for Cancer Care — Augusta
- Maine Medical Partners Otolaryngology — Portland
Arizona
- Kingman Regional Medical Center — Kingman
Colorado
- Rocky Mountain Cancer Centers-Boulder — Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04208490
The ClinicalTrials.gov registry entry for NCT04208490 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention — of which HN-STAR Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04208490 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Illinois, Delaware, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04208490 about?
NCT04208490 is a clinical study titled "Implementation and Effectiveness Trial of HN-STAR". People who have been treated for head and neck cancer (HNC survivors) can experience serious consequences from their cancer and its treatment, ongoing risks of new cancers, and other unrelated illnesses. These concerns pose challenges to the provision of comprehensive care to HNC survivors. We creat...
What is the current status of trial NCT04208490?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 357 participants. The study started on 2021-02-23. Estimated completion is 2027-06-30.
What conditions does trial NCT04208490 study?
This clinical trial studies the following conditions: Head and Neck Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04208490?
The interventions under investigation include: HN-STAR Intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04208490?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04208490 being conducted?
This trial has 20 study locations across Arizona, Colorado, Delaware, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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