Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04208490 · ClinicalTrials.gov registry record · NA
Implementation and Effectiveness Trial of HN-STAR
A NA study of Head and Neck Cancer, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- NA
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT04208490 is a NA study of Head and Neck Cancer that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 357 participants, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT04208490, a NA study of Head and Neck Cancer, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (38% higher). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
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.
NCT04208490 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Illinois, Delaware, District of Columbia.
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.
What interventions are being tested in trial NCT04208490?
The interventions under investigation include: HN-STAR Intervention (OTHER).
Who is sponsoring clinical trial NCT04208490?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
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.
-
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
RECRUITING · NA
-
Improving Care for Rural Patients With Solid Tumors
RECRUITING · NA
-
Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck
RECRUITING · NA
-
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
RECRUITING · NA
-
Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients
RECRUITING · NA
-
Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.