Clinical trial NCT04208490: Implementation and Effectiveness Trial of HN-STAR
Official title: Implementation and Effectiveness Trial of HN-STAR
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Survivorship
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Memorial Sloan Kettering Cancer Center
First posted: 2019-12-23
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HNC-Specific QOL
timeFrame: Baseline & 1 year
Secondary outcomes:
measure: Change in QoL
timeFrame: Baseline & 1 year
measure: Change in QoL
timeFrame: Baseline & 1 year
measure: Change symptom burden
timeFrame: Baseline & 1 year
measure: Change in symptom burden
timeFrame: Baseline & 1 year
measure: Change in pain
timeFrame: Baseline & 1 year
measure: Change in patient activation
timeFrame: Baseline & 1 year
measure: Change in perceived quality of cancer care
timeFrame: Baseline & 1 year
measure: Adherence and surveillance of guideline concordant care
timeFrame: These variables will be derived from the medical record during the year following the initial visit.
Other outcomes:
Locations:
city: Kingman
country: United States
facility: Kingman Regional Medical Center
state: Arizona
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers-Boulder
state: Colorado
city: Frankford
country: United States
facility: Beebe South Coastal Health Campus
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: John H Stroger Jr Hospital Cook County
state: Illinois
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Richmond
country: United States
facility: Reid Health
state: Indiana
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Medical Center - Des Moines
state: Iowa
city: Augusta
country: United States
facility: Harold Alfond Center for Cancer Care
state: Maine
city: Portland
country: United States
facility: Maine Medical Partners Otolaryngology
state: Maine
city: South Portland
country: United States
facility: Maine Medical Partners - South Portland
state: Maine
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Henderson
country: United States
facility: OptumCare Cancer Care at Seven Hills
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Charleston
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Fort Apache
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Cancer Center
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Midlothian
country: United States
facility: Bon Secours Saint Francis Medical Center
state: Virginia
city: Antigo
country: United States
facility: Aspirus Langlade Hospital
state: Wisconsin
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Appleton
country: United States
facility: Ascension Saint Elizabeth Hospital
state: Wisconsin
city: Franklin
country: United States
facility: Ascension Saint Francis - Reiman Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Milwaukee
country: United States
facility: Ascension Columbia Saint Mary's Hospital - Milwaukee
state: Wisconsin
city: Rhinelander
country: United States
facility: Aspirus Cancer Care - James Beck Cancer Center
state: Wisconsin
city: Stevens Point
country: United States
facility: Aspirus Cancer Care - Stevens Point
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Regional Cancer Center
state: Wisconsin
Study officials:
References: