Implementation and Effectiveness Trial of HN-STAR
HN-STAR
4 other identifiers
interventional
357
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Feb 2021
Longer than P75 for not_applicable head-and-neck-cancer
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 15, 2026
April 1, 2026
5.4 years
December 4, 2019
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change in QoL
Baseline & 1 year
Change in QoL
Baseline & 1 year
Change symptom burden
Baseline & 1 year
Change in symptom burden
Baseline & 1 year
Change in pain
Baseline & 1 year
- +3 more secondary outcomes
Study Arms (2)
HN-STAR
OTHERUsual Care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centercollaborator
- Wake Forest University Health Scienceslead
- National Cancer Institute (NCI)collaborator
Study Sites (49)
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Beebe South Coastal Health Campus
Frankford, Delaware, 19945, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
John H Stroger Jr Hospital Cook County
Chicago, Illinois, 60612, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Reid Health
Richmond, Indiana, 47374, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Maine Medical Partners Otolaryngology
Portland, Maine, 04101, United States
Maine Medical Partners - South Portland
South Portland, Maine, 04106, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Aspirus Langlade Hospital
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 23, 2019
Study Start
February 23, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon request to NCORP@wakehealth.edu
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.