HN-STAR for Head and Neck Cancer (HN-STAR Trial)
Recruiting in Palo Alto (17 mi)
+49 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
Is the HN-STAR tool safe for use in humans?
The available research does not provide specific safety data for the HN-STAR tool, as it focuses on improving care for head and neck cancer survivors rather than evaluating safety.
26789What data supports the effectiveness of the HN-STAR treatment for head and neck cancer?
The HN-STAR tool is designed to improve the care of head and neck cancer survivors by incorporating patient feedback into a care plan, which can help manage long-term effects and improve quality of life. Survivorship care plans like HN-STAR are important for coordinating care and promoting healthy lifestyles, which are crucial for long-term survival and quality of life in cancer survivors.
3481011What makes the HN-STAR treatment unique for head and neck cancer?
HN-STAR is unique because it is an electronic tool that helps create personalized care plans for head and neck cancer survivors by using patient feedback to guide decisions, unlike traditional treatments that focus solely on medical interventions.
145810Do I have to stop taking my current medications for the HN-STAR trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your healthcare provider.
Eligibility Criteria
This trial is for adults over 18 who've been treated for head and neck cancer, are currently free of disease, and have finished chemo or radiation within the last two years. They must be able to complete surveys and attend follow-up clinic visits.Inclusion Criteria
I am 18 years old or older.
My last health check showed no signs of disease.
I have been diagnosed with a specific type of throat or mouth cancer.
Participant Groups
HN-STAR, a digital tool designed to improve care for head and neck cancer survivors by tailoring ongoing care based on their reported symptoms. The study compares HN-STAR's effectiveness against usual care in improving patient outcomes over one year.
2Treatment groups
Experimental Treatment
Active Control
Group I: HN-STARExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
HN-STAR Intervention is already approved in United States for the following indications:
🇺🇸 Approved in United States as HN-STAR for:
- Survivorship care for head and neck cancer survivors
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
ThedaCare Regional Cancer CenterAppleton, WI
Medical University of South CarolinaCharleston, SC
Saint Vincent Hospital Cancer Center Green BayGreen Bay, WI
Bon Secours Saint Francis Medical CenterMidlothian, VA
More Trial Locations
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
Memorial Sloan Kettering Cancer CenterCollaborator
National Cancer Institute (NCI)Collaborator
References
Survivorship in Head and Neck Cancer: A Primer. [2018]Survivors of cancer and cancer-directed therapies may encounter substantial medical, psychosocial, interpersonal, financial, and functional consequences. The collective experience of being a cancer survivor has been dubbed survivorship. As a unique discipline, cancer survivorship has garnered much attention in recent years. However, its constructs have yet to be formally introduced or applied to head and neck oncology. Recognizing this, the American Head and Neck Society (AHNS) has convened a committee on survivorship. The concept of survivorship is reviewed and placed into historical perspective to identify current gaps in head and neck survivor care and to provide a roadmap for future initiatives in survivorship care and research.
A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study. [2020]Head and neck cancer survivors commonly experience severe long-term toxicities, late-occurring symptoms, and significant risks of the second primary malignancy and comorbid illnesses. With multiple simultaneous health issues, these complex cancer survivors often do not receive comprehensive health care that addresses their needs. A tool is needed to streamline and standardize comprehensive care for this cohort.
Development of a survivorship needs assessment planning tool for head and neck cancer survivors and their caregivers: a preliminary study. [2018]The purpose of this study was to characterize primary end-of-treatment challenges in head and neck cancer (HNC) to drive the development of a survivorship needs assessment planning (SNAP) tool and evaluate its acceptability and feasibility.
Survivorship Care Planning and Quality of Life. [2019]Roughly 436,000 survivors are living with a history of head and neck cancer (HNC), accounting for approximately 3% of all cancer survivors in the United States [1, 2]. With advances in treatment, long-term survival is increasingly common in HNC populations. Despite increasing awareness of survivorship issues, many challenges remain. These include lack of knowledge on late and long-term effects of treatment, and poor integration of survivorship care guidelines into oncology practice. Survivorship care plans (SCPs) are increasingly important for HNC survivors to improve quality of long-term survival. Quality survivorship care should focus on management of late and long-term effects of treatment, surveillance for cancer recurrence and second primaries, promotion of healthy lifestyle, and care coordination between providers. This chapter will describe common quality of life (QOL) issues in HNC survivorship, and review the current survivorship care guidelines in HNC.
Head and Neck Squamous Cell Carcinoma in Adolescents and Young Adults: Survivorship Patterns and Disparities. [2022]Adolescent and young adult (AYA) head and neck cancer (HNC) patients require longer term follow-ups as they age; yet, little is known about factors associated with survivorship in this population. We aimed to describe nonclinical factors associated with HNC survivorship among AYAs.
Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. [2022]Head and neck cancer is occurring in an increasingly younger patient population, with treatment toxicity that can cause significant morbidity. Using a patient guided, Internet-based survivorship care plan program, we obtained and looked at patterns of patient-reported outcomes data from survivors seeking information after treatment for head and neck cancer.
Burden of treatment: Reported outcomes in a head and neck cancer survivorship clinic. [2020]With the intensification and utilization of multimodal treatment, acute toxicities have increased; however, the frequency of treatment sequelae in long-term head and neck cancer (HNC) survivors are poorly described. The purpose of this analysis was to determine the prevalence and predictors of patient-reported late and long-term treatment-related sequelae in HNC survivors.
Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer. [2019]To improve the care of survivors of head and neck cancer, we developed the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR). HN-STAR is an electronic platform that incorporates patient-reported outcomes into a clinical decision support tool for use at a survivorship visit. Selections in the clinical decision support tool automatically populate a survivorship care plan (SCP). We aimed to refine HN-STAR by eliciting and incorporating feedback on its ease of use and usefulness.
Young head and neck cancer patients are at increased risk of developing oral mucositis and trismus. [2020]To evaluate cancer treatment-related toxicities in young head and neck cancer (HNC) patients.
Head and neck cancer survivorship from the patient perspective. [2021]Survivorship is a critical part of head and neck cancer (HNC) care. In order to design better processes, we assessed care provided to long-term HNC survivors and their priorities for ongoing care.
Subjective and Objective Measures in Assessing Neck Disability and Pain in Head and Neck Cancer. [2021]The intensification of treatment for head and neck cancers (HNCs) has created a cohort of patients living with short- and long-term comorbidities and functional deficits. This study aimed to determine whether there is a relationship between patient-reported outcomes (PROs) and objective measures of neck function in survivors of HNCs.