Implementation and Effectiveness Trial of HN-STAR (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 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 Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: HN-STAR Intervention

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Other: HN-STAR	Other: HN-STAR Intervention; The Head and Neck Survivorship Tool (HN-STAR) is a web-based tool used to assist clinicians in implementing the ACS/ASCO HNC survivorship guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HNC-Specific QOL	Measured using Trial Outcome Index from the Functional Assessment of Cancer Therapy Head and Neck. It is a 23-item summary measure that ranges from 0 to a maximum of 96 where higher scores indicate better overall physical and functional outcomes.	Baseline & 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QoL	Measured using domains and overall measures from the FACT H&N. The total score evaluates overall QoL in Head and Neck Cancer patients and ranges from 0 to 144, with higher scores indicating better overall QoL. Subscales are calculated by summing the relevant questions [answered using a Likert scale ranging from 0 (Not at all) to 4 (Very much)]. Higher scores on subscales represent a better health state.	Baseline & 1 year
Change in QoL	Measured using scales from the EORTC QLQ-C30. Scales from the EORTC QLQ-C30 evaluate functional status, global health status and symptoms. All scales range from 0 to 100, with higher scores representing higher functioning, QoL or symptoms.	Baseline & 1 year
Change symptom burden	Measured using scales from the EORTC QLQ-HN43. Symptom subscales from the EORTC QLQ- HN43 range from 0 to 100, with higher scores representing higher symptom burden.	Baseline & 1 year
Change in symptom burden	Measured using PRO-CTCAE items for relevant symptoms.	Baseline & 1 year
Change in pain	Measured using Brief Pain Inventory Short Form. Pain severity and interference items are measured using a scale from 0 to 10, with higher scores indicating worse pain or interference. The average is used as a summary measure of pain severity and pain interference.	Baseline & 1 year
Change in patient activation	Measured using Patient Activation Measure Short Form. PAM score ranges from 0 to 100, with higher score meaning higher level of activation.	Baseline & 1 year
Change in perceived quality of cancer care	Measured using the CAHPS® Cancer Care Survey.	Baseline & 1 year
Adherence and surveillance of guideline concordant care	Rate at which survivors had ≥1 visit to a primary care provider in the year following the initial visit will be compared by arm. Receipt or non-receipt of guideline-concordant cancer surveillance will be derived from the oncology medical records and compared by arm.	These variables will be derived from the medical record during the year following the initial visit.

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Survivorship
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: IRB00060694; NCI-2019-03600 (Registry Identifier: NCI CTRP); 5UG1CA189824 (U.S. NIH Grant/Contract); WF-1805CD (Other Identifier: WF NCORP RB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
• IPD Sharing Time Frame: 6 months after publication for a 2 year duration
• IPD Sharing Access Criteria: upon request to NCORP@wakehealth.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No