Major Program
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Wake Forest University Health Sciences
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT04208490
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 ≥30 oncology practices from the National Community Oncology Research
Program to use HN-STAR or provide usual care to 350 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.
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 ≥30 oncology practices from the National Community Oncology Research
Program to use HN-STAR or provide usual care to 350 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.
Intervention
HN-STAR Intervention
Condition
Head and Neck Cancer
Investigators
Richard L. Deming, Pamala A. Pawloski, Preston D. Steen, Leander Cannick, Robert D. Siegel, Jeffrey K. Giguere, Amarinthia (Amy) Curtis, William J. Irvin, Tanmay Sahai, Vatche Tchekmedyian, Evan M. Graboyes, Harsha V. Poola, Bryan A. Faller, Dr. Sharad A Ghamande, Joshua Luckenbill, Ki Young Chung, Nicholas DiBella, Howard M Gross, Marcus S Noel, Sorab Gupta, Gregory A Masters, Christa Braun-Inglis, Timothy D Moore, Anthony J Jaslowski