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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
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

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Phoebe Putney Memorial Hospital
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AlbanyUnited StatesUnknown status
AnMed Health Cancer Center
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AndersonUnited StatesUnknown status
Aspirus Langlade Hospital
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AntigoUnited StatesUnknown status
Ascension Saint Elizabeth Hospital
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AppletonUnited StatesUnknown status
ThedaCare Regional Cancer Center
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AppletonUnited StatesUnknown status
Harold Alfond Center for Cancer Care
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AugustaUnited StatesUnknown status
Augusta University Medical Center
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AugustaUnited StatesUnknown status
Rocky Mountain Cancer Centers-Boulder
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BoulderUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
John H Stroger Jr Hospital Cook County
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ChicagoUnited StatesUnknown status
Carle on Vermilion
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DanvilleUnited StatesUnknown status
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Iowa Methodist Medical Center
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Des MoinesUnited StatesUnknown status
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesUnknown status
Sanford Roger Maris Cancer Center
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FargoUnited StatesUnknown status
Beebe South Coastal Health Campus
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FrankfordUnited StatesUnknown status
Ascension Saint Francis - Reiman Cancer Center
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FranklinUnited StatesUnknown status
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesUnknown status
Saint Francis Hospital
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GreenvilleUnited StatesUnknown status
Saint Francis Cancer Center
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Faris
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Butternut
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GreenvilleUnited StatesUnknown status
OptumCare Cancer Care at Seven Hills
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HendersonUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Kingman Regional Medical Center
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KingmanUnited StatesUnknown status
OptumCare Cancer Care at Fort Apache
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at Charleston
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Las VegasUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
Bon Secours Saint Francis Medical Center
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MidlothianUnited StatesUnknown status
Ascension Columbia Saint Mary's Hospital - Milwaukee
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MilwaukeeUnited StatesUnknown status
Licking Memorial Hospital
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NewarkUnited StatesUnknown status
Maine Medical Partners Otolaryngology
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PortlandUnited StatesUnknown status
Beebe Health Campus
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Rehoboth BeachUnited StatesUnknown status
Aspirus Cancer Care - James Beck Cancer Center
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RhinelanderUnited StatesUnknown status
Reid Health
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RichmondUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Maine Medical Partners - South Portland
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South PortlandUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
Aspirus Cancer Care - Stevens Point
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Stevens PointUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
MedStar Washington Hospital Center
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Washington D.C.United StatesUnknown status
MedStar Georgetown University Hospital
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Washington D.C.United StatesUnknown status
Aspirus Regional Cancer Center
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WausauUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.