Implementation and Effectiveness Trial of HN-STAR

NCT ID: NCT04208490

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2027-06-30

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

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HN-STAR

Group Type: OTHER

HN-STAR Intervention

Intervention Type: OTHER

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.

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

• 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.

• Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
• Age >= 18
• MD, DO, NP, or PA

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.

• Is the designated clinician at the practice.

• Provides Oncology Care

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Decatur Memorial Hospital

Decatur, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Carle on Vermilion

Danville, Illinois, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

John H Stroger Jr Hospital Cook County

Chicago, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Reid Health

Richmond, Indiana, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Maine Medical Partners Otolaryngology

Portland, Maine, United States

Maine Medical Partners - South Portland

South Portland, Maine, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Licking Memorial Hospital

Newark, Ohio, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

AnMed Health Cancer Center

Anderson, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, United States

Aspirus Langlade Hospital

Antigo, Wisconsin, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Ascension Saint Elizabeth Hospital

Appleton, Wisconsin, United States

Ascension Saint Francis - Reiman Cancer Center

Franklin, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Ascension Columbia Saint Mary's Hospital - Milwaukee

Milwaukee, Wisconsin, United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Countries

United States

Other Identifiers

NCI-2019-03600

Identifier Type: REGISTRY

Identifier Source: secondary_id

WF-1805CD

Identifier Type: OTHER

Identifier Source: secondary_id

5UG1CA189824

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00060694

Identifier Type: -

Identifier Source: org_study_id