Implementation and Effectiveness of HN-STAR in Managing the Health of Head and Neck Squamous Cell Cancer Survivors
18 Years and older, Male and Female
WF-1805CD (primary)
WF-1805CD
WF-1805CD
NCI-2019-03600
Summary
This trial studies how a computer program, the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) works in helping health care providers care for survivors of head and neck squamous cell cancer. HN-STAR is a type of survivorship tool that survivors and their health care providers may use together to better manage the survivors' health.
Objectives
PRIMARY OBJECTIVE:
I. Evaluate the impact of HN-STAR, compared to controls, on change in patient-centered outcomes from baseline to one-year follow-up.
SECONDARY OBJECTIVES:
I. Evaluate the impact of HN-STAR, compared to controls, on receipt of guideline-concordant care in the year after enrollment, including a visit to a primary care provider in the year following the designated clinic visit.
II. Conduct a robust, mixed methods evaluation of the implementation process, including assessments of survivor, health care provider (oncology and primary care), and organizational barriers and facilitators that may influence integration of HN-STAR in various National Cancer Institute Community Oncology Research Program (NCORP) settings.
OUTLINE: Clinics are randomized to 1 of 2 arms. Patients are assigned to Arm I or II based on clinic randomization.
ARM I: Within 6 months of patient completing treatment, patients meet with the designated clinician for routine clinic visit in accordance with usual care.
ARM II: Within 6 months of patient completing treatment, patients complete a Survivor Health Assessment before meeting with the designated clinician for a clinic visit. Patients receive a survivorship care plan from HN-STAR at the clinic visit that summarizes the patient's cancer history and outlines a plan for ongoing care. Patients then complete Survivor Health Assessments and receive survivorship care plans at 3, 6, and 9 months after clinic visit.
After completion of study, patients are followed up at 1 year.
Eligibility
- NCORP PRACTICE: Willing to incorporate the web-based HN-STAR into their clinical practice
- NCORP PRACTICE: Treated >= 12 newly diagnosed cases of head and neck cancer patients within the last 12 months (or the last 12 months of available data)
- NCORP PRACTICE: Can identify at least one designated clinician who is willing to be trained on and use HN-STAR or conduct usual care for enrolled survivors
- SURVIVOR: Age >= 18 years
- SURVIVOR: Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary
- SURVIVOR: Completed chemotherapy and/or radiation therapy (with or without surgery) with curative intent for head and neck squamous cell carcinoma =< 24 months prior to designated clinician visit
- SURVIVOR: Deemed free of disease at last assessment (per scan or clinical assessment)
- SURVIVOR: Cognitively and physically able to complete study survey per local NCORP site staff discretion
- SURVIVOR: Scheduled for a clinic visit with a provider who has agreed to participate in this study
- SURVIVOR: Willing to complete study assessments after the designated clinic visit either 1) remotely (via telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic on a clinic tablet or computer
- DESIGNATED CLINICIAN: Age >= 18 years
- DESIGNATED CLINICIAN: Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), nurse practitioner (NP), or physician's assistant (PA)
- DESIGNATED CLINICIAN: Able to speak and read English, because the HN-STAR tool is only available in English at this time
- DESIGNATED CLINICIAN: Routinely provides care for cancer patients or survivors
- DESIGNATED CLINICIAN: Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
- STAKEHOLDERS: Age >= 18 years
- STAKEHOLDERS: 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)
- STAKEHOLDERS: Employed for at least one month at the practice
- STAKEHOLDERS: Able to speak and read English, because the HN-STAR tool is only available in English at this time
- PRIMARY CARE PROVIDER: Provides primary care (general preventive care) to a survivor enrolled in the HN-STAR study
- PRIMARY CARE PROVIDER: Age >= 18 years
- PRIMARY CARE PROVIDER: MD, DO, NP, or PA
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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