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Completed Not applicable Interventional

Implementation and Effectiveness Trial of HN-STAR

ClinicalTrials.gov ID: NCT04208490

Public ClinicalTrials.gov record NCT04208490. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 2:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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, providers, and other clinic staff to understand the feasibility, acceptability, appropriateness, and other aspects of providing survivorship care to head and neck cancer survivors.

Study identification

NCT ID
NCT04208490
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
357 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 22, 2021
Primary completion
May 11, 2026
Completion
May 20, 2026
Last update posted
Jul 23, 2026

2021 – 2026

United States locations

U.S. sites
49
U.S. states
20
U.S. cities
40
Facility City State ZIP Site status
Kingman Regional Medical Center Kingman Arizona 86401
Rocky Mountain Cancer Centers-Boulder Boulder Colorado 80304
Beebe South Coastal Health Campus Frankford Delaware 19945
Beebe Health Campus Rehoboth Beach Delaware 19971
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010
Phoebe Putney Memorial Hospital Albany Georgia 31701
Augusta University Medical Center Augusta Georgia 30912
Queen's Medical Center Honolulu Hawaii 96813
John H Stroger Jr Hospital Cook County Chicago Illinois 60612
Carle at The Riverfront Danville Illinois 61832
Carle on Vermilion Danville Illinois 61832
Decatur Memorial Hospital Decatur Illinois 62526
Carle Physician Group-Mattoon/Charleston Mattoon Illinois 61938
Carle Cancer Center Urbana Illinois 61801
Reid Health Richmond Indiana 47374
Iowa Methodist Medical Center Des Moines Iowa 50309
Mercy Medical Center - Des Moines Des Moines Iowa 50314
Harold Alfond Center for Cancer Care Augusta Maine 04330
Maine Medical Partners Otolaryngology Portland Maine 04101
Maine Medical Partners - South Portland South Portland Maine 04106
Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota 55416
Regions Hospital Saint Paul Minnesota 55101
OptumCare Cancer Care at Seven Hills Henderson Nevada 89052
OptumCare Cancer Care at Charleston Las Vegas Nevada 89102
OptumCare Cancer Care at Fort Apache Las Vegas Nevada 89148
Montefiore Medical Center-Einstein Campus The Bronx New York 10461
Montefiore Medical Center - Moses Campus The Bronx New York 10467
Sanford Roger Maris Cancer Center Fargo North Dakota 58122
Licking Memorial Hospital Newark Ohio 43055
Geisinger Medical Center Danville Pennsylvania 17822
AnMed Health Cancer Center Anderson South Carolina 29621
Medical University of South Carolina Charleston South Carolina 29425
Saint Francis Hospital Greenville South Carolina 29601
Prisma Health Cancer Institute - Butternut Greenville South Carolina 29605
Prisma Health Cancer Institute - Faris Greenville South Carolina 29605
Saint Francis Cancer Center Greenville South Carolina 29607
Spartanburg Medical Center Spartanburg South Carolina 29303
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134
Bon Secours Saint Francis Medical Center Midlothian Virginia 23114
Aspirus Langlade Hospital Antigo Wisconsin 54409
ThedaCare Regional Cancer Center Appleton Wisconsin 54911
Ascension Saint Elizabeth Hospital Appleton Wisconsin 54915
Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin 53132
Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin 54301
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin 53211
Aspirus Cancer Care - James Beck Cancer Center Rhinelander Wisconsin 54501
Aspirus Cancer Care - Stevens Point Stevens Point Wisconsin 54481
Aspirus Regional Cancer Center Wausau Wisconsin 54401

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04208490, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 23, 2026 · Synced Sep 8, 2026

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Open the official record

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