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Implementation and Effectiveness Trial of HN-STAR (WF-1805CD)

Testing the Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Overview

Overview

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.

Key Inclusion Criteria

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Survivor Inclusion Criteria:
    • Age ≥18 years.
    • Diagnosis of head and neck squamous cell carcinoma, specifically oral cavity, larynx, any part of pharynx and unknown squamous cell carcinoma primary.
    • Completed chemotherapy and/or radiation therapy for head and neck squamous cell carcinoma ≤ 6 months prior to enrollment.
    • Deemed free of disease at last assessment.
    • Cognitively and physically able to complete study survey per local NCORP site staff discretion.
    • Scheduled for a clinic visit with a provider who has agreed to participate in this study and meets requirements for the arm to which their practice has been assigned (the practice designated clinician) for routine follow-up.
    • Willing to complete study assessments 3, 6, and 9 months after the designated clinic visit either 1) remotely (via smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
  • Designated Clinician Inclusion Criteria:
    • Age > = 18 years
    • MD, DO, NP, or PA
    • Able to speak and read English, because the HN-STAR tool is only available in English at this time.
    • Routinely provides care for cancer patients or survivors.
    • Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
    • Agrees to participate in one confidential 1-on-1 semi-structured telephone interviews conducted by the Memorial Sloan Kettering (MSK) research associate, which will be taped, transcribed and qualitatively analyzed.
    • Agrees to complete brief post-visit surveys for each study participant.
    • Agrees to complete one brief, confidential telephone interview during completion of the Provider and Service List with the Memorial Sloan Kettering (MSK) research associate, which will be taped, transcribed and qualitatively analyzed.
  • Stakeholders Inclusion Criteria:
    • Age > = 18
    • 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, information technology specialists, and other staff (e.g., service line or nursing leaders).
    • Agrees to participate in two surveys (pre and post-implementation) and two confidential semi-structured telephone interviews conducted by the Memorial Sloan Kettering (MSK) research associate, which will be taped, transcribed and qualitatively analyzed.
    • Employed for at least one month at the practice.
    • Able to speak and reads English, because the HN-STAR tool is only available in English at this time.
  • Primary Care Provider Inclusion Criteria:
    • Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
    • Age >= 18
    • MD, DO, NP, or PA
    • Agrees to complete one brief, confidential telephone interview, conducted by the MSK research team, which will be tape, transcribed and qualitatively analyzed.
Key Exclusion Criteria

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Survivor Exclusion Criteria:
    • History of any other cancer, other than non-melanoma skin disease.
    • Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
    • Diagnosed with a prior primary head and neck cancer.
    • Does not speak or read English, because the HN-STAR tool is only available in English at this time.
    • Received only surgery as treatment for head and neck cancer.
    • Current, planned enrollment, or in follow-up on another interventional symptom management study protocol, as per patient self-report or research staff members' knowledge at the time of consent. Concurrent participation in treatment or imaging studies is allowed.
  • Stakeholder Exclusion Criteria:
    • Is the designated clinician at the practice.
  • Primary Care Provider Exclusion Criteria:
    • Provides Oncology Care
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

N/A

Principal Investigator(s)

Amarinthia Curtis, MD

Sponsor(s)

Wake Forest University Health Sciences

Contact Us

Contact Us

To participate in this study, please contact Mohsen Alqalam at
864-560-1056
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