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Brief Title: Implementation and Effectiveness Trial of HN-STAR
Official Title: Implementation and Effectiveness Trial of HN-STAR
Study ID: NCT04208490
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kingman Regional Medical Center, Kingman, Arizona, United States
Beebe South Coastal Health Campus, Frankford, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
MedStar Washington Hospital Center, Washington, District of Columbia, 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 on Vermilion, Danville, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Carle Cancer Center, Urbana, Illinois, 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, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, 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
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, 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