HN-STAR for Head and Neck Cancer

(HN-STAR Trial)

Recruiting at 49 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

357 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

What 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. ^{1 3 4 10 11}

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.

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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer. [2019]

2. United States 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Head and neck cancer survivorship from the patient perspective. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Survivorship Care Planning and Quality of Life. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Subjective and Objective Measures in Assessing Neck Disability and Pain in Head and Neck Cancer. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Young head and neck cancer patients are at increased risk of developing oral mucositis and trismus. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Burden of treatment: Reported outcomes in a head and neck cancer survivorship clinic. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Head and Neck Squamous Cell Carcinoma in Adolescents and Young Adults: Survivorship Patterns and Disparities. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Survivorship in Head and Neck Cancer: A Primer. [2018]