Implementation and Effectiveness Trial of HN-STAR

Head and Neck Cancer Clinical Trial

— HN-STAR  

Official title:

Implementation and Effectiveness Trial of HN-STAR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208490
• Other study ID #: IRB00060694
• Secondary ID: NCI-2019-03600WF
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Karen Craver
• Phone: 336-716-0891
• Email: NCORP[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Aspirus Langlade Hospital	Antigo	Wisconsin
United States	Augusta University Medical Center	Augusta	Georgia
United States	Harold Alfond Center for Cancer Care	Augusta	Maine
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center-Einstein Campus	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	John H Stroger Jr Hospital Cook County	Chicago	Illinois
United States	Carle on Vermilion	Danville	Illinois
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	Beebe South Coastal Health Campus	Frankford	Delaware
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
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	Saint Francis Hospital	Greenville	South Carolina
United States	OptumCare Cancer Care at Seven Hills	Henderson	Nevada
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Kingman Regional Medical Center	Kingman	Arizona
United States	OptumCare Cancer Care at Charleston	Las Vegas	Nevada
United States	OptumCare Cancer Care at Fort Apache	Las Vegas	Nevada
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Bon Secours Saint Francis Medical Center	Midlothian	Virginia
United States	Licking Memorial Hospital	Newark	Ohio
United States	Maine Medical Partners Otolaryngology	Portland	Maine
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Aspirus Cancer Care - James Beck Cancer Center	Rhinelander	Wisconsin
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Maine Medical Partners - South Portland	South Portland	Maine
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Aspirus Cancer Care - Stevens Point	Stevens Point	Wisconsin
United States	Carle Cancer Center	Urbana	Illinois
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in symptom burden	Measured using PRO-CTCAE items for relevant symptoms.	Baseline & 1 year
Secondary	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
Secondary	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
Secondary	Change in perceived quality of cancer care	Measured using the CAHPS® Cancer Care Survey.	Baseline & 1 year
Secondary	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.