HN-STAR for Head and Neck Cancer

(HN-STAR Trial)

Not currently recruiting at 53 trial locations

Overseen By Karen Craver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Active cancer treatment, Prior cancer, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for individuals who have survived head and neck cancer. It tests a tool called HN-STAR (Head and Neck Survivorship Tool: Assessment and Recommendations), which assists patients and doctors in identifying and managing symptoms and health concerns during routine visits. Participants will either use HN-STAR or receive the usual care to determine which method more effectively improves well-being and symptom management. The trial seeks individuals who completed treatment for head and neck cancer within the last two years and are currently disease-free. As an unphased trial, this study offers participants the chance to contribute to innovative care strategies that could enhance survivorship experiences for others.

Do 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.

What prior data suggests that the HN-STAR intervention is safe for head and neck cancer survivors?

Research has shown that HN-STAR is a safe, digital tool for head and neck cancer survivors. It enables them to report symptoms and health concerns, allowing doctors to create personalized care plans. As a computer program, not a medication or medical procedure, it has no reported physical side effects.

Studies have found that survivors consider HN-STAR useful for managing ongoing care. The goal is to enhance quality of life without introducing new health risks. In past studies, participants used HN-STAR without safety issues. It primarily improves communication between patients and healthcare providers and ensures care aligns with the latest guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HN-STAR intervention for head and neck cancer because it could offer new insights into improving patient care. Unlike traditional treatments that often focus solely on medical interventions like surgery, radiation, or chemotherapy, HN-STAR might explore innovative ways to enhance the overall treatment experience. This could involve better integration of supportive care, personalized treatment plans, or novel therapeutic combinations. By focusing on these aspects, the trial aims to uncover methods that could lead to improved outcomes and quality of life for patients with head and neck cancer.

What evidence suggests that HN-STAR is effective for head and neck cancer survivors?

This trial will compare the HN-STAR tool with usual care for head and neck cancer survivors. Research has shown that the HN-STAR tool can enhance care by managing symptoms and boosting overall well-being more effectively than usual care. Patients using HN-STAR are more likely to receive care aligned with proven guidelines. This tool helps doctors and patients decide on the best tests or treatments based on individual needs. Early results suggest that this approach can increase patient satisfaction and improve health outcomes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 willing to complete study check-ins online or at the clinic at 3, 6, and 9 months.

You have a scheduled clinic appointment with a doctor who has agreed to participate in this study and can provide routine follow-up care for your assigned study arm.

My last health check showed no signs of disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys to assess quality of life and symptom burden

1 week

1 visit (in-person or virtual)

Intervention

Participants use HN-STAR to report symptoms and receive a survivorship care plan during routine visits

12 months

Routine visits every 3 months

Follow-up

Participants are monitored for changes in quality of life and symptom burden

1 year

Surveys at baseline and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• HN-STAR Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: HN-STAR Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

There are approximately 436,000 survivors of head and neck cancer in the U.S., highlighting the importance of addressing their unique long-term care needs as survival rates improve.

Survivorship care plans (SCPs) are essential for managing late effects of treatment, monitoring for cancer recurrence, and promoting healthy lifestyles, yet there is a need for better integration of these plans into oncology practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship Care Planning and Quality of Life. Economou, D., Sun, V.[2019]

Cancer survivors, especially those treated for head and neck cancers, face a range of challenges including medical, psychosocial, and financial issues, highlighting the need for comprehensive survivorship care.

The American Head and Neck Society has recognized the importance of survivorship and is working to establish guidelines and initiatives to improve care and research for head and neck cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship in Head and Neck Cancer: A Primer. Miller, MC., Shuman, AG.[2018]

A total of 602 head and neck cancer survivors provided patient-reported outcomes through an Internet-based survivorship care plan program, highlighting the effectiveness of this approach in gathering valuable data.

The most common treatment-related toxicities reported were difficulty swallowing (61.5%) and changes in skin color/texture (49.7%), indicating that these issues, along with fatigue, are significant concerns that need to be addressed in survivorship care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. Peach, MS., Trifiletti, DM., Vachani, C., et al.[2022]

The Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) is an electronic platform designed to streamline and standardize comprehensive care for head and neck cancer survivors, addressing their complex health needs through personalized care.

This feasibility study will assess the usability and practicality of HN-STAR in clinical settings, with the goal of informing a larger trial to improve survivorship care, potentially benefiting survivors of other complex cancers as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study. Salz, T., McCabe, MS., Oeffinger, KC., et al.[2020]

In a study of 44 head and neck cancer patients, younger patients (under 45 years) experienced significantly higher rates and severity of oral mucositis (OM) and trismus during treatment compared to older patients (over 58 years), despite similar treatment protocols.

Both age groups showed high incidences of oral toxicities, with OM and xerostomia being the most common, but the younger group had worse outcomes, particularly at the 21st and 35th days of treatment, indicating a need for tailored management strategies for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young head and neck cancer patients are at increased risk of developing oral mucositis and trismus. Morais-Faria, K., Palmier, NR., de Lima Correia, J., et al.[2020]

In a study of 228 head and neck cancer survivors, 56% reported at least three treatment-related effects that significantly impacted their daily lives, highlighting the high prevalence of long-term treatment sequelae.

Longer time since treatment was associated with improved quality of life and reduced anxiety symptoms, but after approximately 6 years, survivors experienced worsening swallowing dysfunction, particularly those diagnosed with advanced stage disease (stage III-IV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burden of treatment: Reported outcomes in a head and neck cancer survivorship clinic. Nilsen, ML., Mady, LJ., Hodges, J., et al.[2020]

A survey of 168 head and neck cancer survivors revealed that 75% prioritize surveillance for cancer recurrence as their main concern, highlighting the importance of monitoring for potential return of the disease.

Only about 10% of survivors reported current opioid use, and many indicated a lack of communication with primary care providers regarding their ongoing cancer care needs, suggesting a gap in comprehensive survivorship planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and neck cancer survivorship from the patient perspective. Pagedar, NA., Kendell, N., Christensen, AJ., et al.[2021]

In a study of 1,777 adolescent and young adult head and neck cancer patients, survival rates were found to be 73% after 8 years, indicating a significant level of survivorship in this population.

Health insurance status was identified as a critical nonclinical factor affecting survival, with patients on Medicaid or uninsured having a higher risk of death compared to those with private insurance, highlighting the need for improved support for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and Neck Squamous Cell Carcinoma in Adolescents and Young Adults: Survivorship Patterns and Disparities. Challapalli, SD., Simpson, MC., Adjei Boakye, E., et al.[2022]

The Head and Neck Survivorship Tool (HN-STAR) is an electronic platform designed to enhance care for head and neck cancer survivors by integrating patient-reported outcomes into a clinical decision support tool, which helps create personalized survivorship care plans.

Feedback from HCI experts, nurse practitioners, and cancer survivors led to significant improvements in HN-STAR's usability, focusing on user interface design, assessment completion ease, and overall efficiency during clinic visits, ensuring the tool is both user-friendly and clinically relevant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer. Salz, T., Schnall, RB., McCabe, MS., et al.[2019]

The study identified key post-treatment challenges for head and neck cancer survivors, caregivers, and healthcare providers, emphasizing the need for a comprehensive survivorship needs assessment tool (SNAP) to address physical, emotional, and social issues.

Participants found the SNAP tool acceptable and feasible, with over 75% expressing comfort using it on a tablet, indicating that technology can effectively support personalized survivorship care plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a survivorship needs assessment planning tool for head and neck cancer survivors and their caregivers: a preliminary study. Sterba, KR., Zapka, J., LaPelle, N., et al.[2018]

In a study of 31 head and neck cancer survivors, a moderate correlation was found between self-reported neck disability and objective measures of neck function, indicating that higher perceived disability is associated with reduced range of motion and velocity in neck movements.

Patients reporting greater neck pain and disability demonstrated significantly lower neck movement capabilities, suggesting that addressing these subjective experiences could enhance treatment planning and improve functional outcomes for survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective and Objective Measures in Assessing Neck Disability and Pain in Head and Neck Cancer. Magaña, LC., Murati, S., Riffitts, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8543489/

The Head and Neck Survivorship Tool (HN-STAR) Trial (WF ... Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic ...

2. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.509

Impact of an ePRO-informed clinical decision support tool ... ... head and neck cancer survivors: Results from the HN-STAR trial (WF-1805CD). Authors: Talya Salz, Emily Van Meter Dressler, Carol A. Kittel ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421001841

The Head and Neck Survivorship Tool (HN-STAR) Trial ... The trial will evaluate differences in key survivorship outcomes between HNC participants who use HN-STAR and those who receive usual care. Section snippets.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02571673

Feasibility Study of the Head and Neck Survivorship Tool ... This study is being done to understand how survivors of head and neck cancer think they can make HN-STAR (the Survivor Self-Assessment, the survivorship clinic ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-03600

Implementation and Effectiveness of HN-STAR in ... This trial studies how a computer program, the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) works in helping health care ...

6. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2021/09/09/study-aims-to-improve-care-for-head-and-neck-cancer-survivors

Study aims to improve care for head and neck cancer survivors Hollings taking part in study to improve the delivery of patient-centered care for head and neck cancer survivors.

7. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-1-2021-04120

HN-STAR for Head and Neck Cancer · Info for Participants Trial Overview HN-STAR, a digital tool designed to improve care for head and neck cancer survivors by tailoring ongoing care based on their reported symptoms.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34023515/

The Head and Neck Survivorship Tool (HN-STAR) Trial (WF ... The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care.