Implementation and Effectiveness Trial of HN-STAR (HN-STAR)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2024
  • participants needed
    470
  • sponsor
    Wake Forest University Health Sciences
Updated on 7 October 2022
Investigator
Karen Craver
Primary Contact
Park Nicollet Clinic - Saint Louis Park (4.1 mi away) Contact
+24 other location
carcinoma
squamous cell carcinoma
dental caries
squamous cell carcinoma of head and neck

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 ≥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.

Details
Condition Head and Neck Cancer
Treatment HN-STAR Intervention
Clinical Study IdentifierNCT04208490
SponsorWake Forest University Health Sciences
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study
Age >= 18
MD, DO, NP, or PA

Exclusion Criteria

Provides Oncology Care
Clear my responses

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