NCT04208490Completed
Implementation and Effectiveness Trial of HN-STAR
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 357 (actual)
- First submitted
- 4 Dec 2019
- Start date
- 23 Feb 2021
- Primary completion date
- 12 May 2026
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT04208490
What you commit to
- Study type: Interventional
- Participants enrolled: 357
- From 23 Feb 2021 to the primary completion date, 12 May 2026
- 49 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Survivor Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary.
- Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
- Deemed free of disease at last assessment.
- Cognitively and physically able to complete study survey per local NCORP site staff discretion.
- Scheduled for a clinic visit with a provider who has agreed to participate in this study and meets requirements for the arm to which their practice has been assigned (the practice designated clinician) for routine follow-up.
- Willing to complete study assessments 3, 6, and 9 months after the designated clinic visit either 1) remotely (via telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
- Survivor Exclusion Criteria:
- In active cancer treatment (including hormone therapy) for any other cancer, excluding local therapy for non-melanoma skin cancer.
- Evidence of prior cancer (excluding non-melanoma skin cancer) within 3 years of the designated clinician visit.
- Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
- Recurrent, persistent, or progressive disease at last assessment (per scan or clinical assessment).
- Does not speak or read English, because the HN-STAR tool is only available in English at this time.
- Received only surgery as treatment for head and neck cancer.
- Current, planned enrollment, or in follow-up on another interventional symptom management study protocol, as per patient self-report or research staff members' knowledge at the time of consent. Concurrent participation in treatment or imaging studies is allowed.
- Designated Clinician Inclusion Criteria:
- Age \> = 18 years
- MD, DO, NP, or PA
- Able to speak and read English, because the HN-STAR tool is only available in English at this time.
- Routinely provides care for cancer patients or survivors.
- Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
- Stakeholders Inclusion Criteria:
- Age \> = 18
- Member of the practice clinical or administrative team who is involved in the oversight of the delivery of head and neck cancer survivorship care or who would make decisions about implementing head and neck survivorship tools such as HN-STAR. This could include clinic administrators, nurse navigators, key clinical team members, program directors, and other staff (e.g., service line or nursing leaders).
- Employed for at least one month at the practice.
- Able to speak and reads English, because the HN-STAR tool is only available in English at this time.
- Stakeholder Exclusion Criteria:
- Is the designated clinician at the practice.
- Primary Care Provider Inclusion Criteria:
- Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
- Age \>= 18
- MD, DO, NP, or PA
- Primary Care Provider Exclusion Criteria:
- Provides Oncology Care
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Phoebe Putney Memorial Hospital Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| AnMed Health Cancer Center Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Aspirus Langlade Hospital Coordinator of this site? Confirm its status | Antigo | United States | Unknown status |
| Ascension Saint Elizabeth Hospital Coordinator of this site? Confirm its status | Appleton | United States | Unknown status |
| ThedaCare Regional Cancer Center Coordinator of this site? Confirm its status | Appleton | United States | Unknown status |
| Harold Alfond Center for Cancer Care Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Rocky Mountain Cancer Centers-Boulder Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| John H Stroger Jr Hospital Cook County Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Carle on Vermilion Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Mercy Medical Center - Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Sanford Roger Maris Cancer Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Beebe South Coastal Health Campus Coordinator of this site? Confirm its status | Frankford | United States | Unknown status |
| Ascension Saint Francis - Reiman Cancer Center Coordinator of this site? Confirm its status | Franklin | United States | Unknown status |
| Saint Vincent Hospital Cancer Center Green Bay Coordinator of this site? Confirm its status | Green Bay | United States | Unknown status |
| Saint Francis Hospital Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Saint Francis Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Prisma Health Cancer Institute - Faris Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Prisma Health Cancer Institute - Butternut Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| OptumCare Cancer Care at Seven Hills Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Queen's Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Kingman Regional Medical Center Coordinator of this site? Confirm its status | Kingman | United States | Unknown status |
| OptumCare Cancer Care at Fort Apache Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| OptumCare Cancer Care at Charleston Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Unknown status |
| Bon Secours Saint Francis Medical Center Coordinator of this site? Confirm its status | Midlothian | United States | Unknown status |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Licking Memorial Hospital Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Maine Medical Partners Otolaryngology Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Beebe Health Campus Coordinator of this site? Confirm its status | Rehoboth Beach | United States | Unknown status |
| Aspirus Cancer Care - James Beck Cancer Center Coordinator of this site? Confirm its status | Rhinelander | United States | Unknown status |
| Reid Health Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Park Nicollet Clinic - Saint Louis Park Coordinator of this site? Confirm its status | Saint Louis Park | United States | Unknown status |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Maine Medical Partners - South Portland Coordinator of this site? Confirm its status | South Portland | United States | Unknown status |
| Spartanburg Medical Center Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Aspirus Cancer Care - Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Aspirus Regional Cancer Center Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.