Virtual Coach for Head Neoplasms

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts Eye and Ear Infirmary, Boston, MA
Head Neoplasms+1 More
Virtual Coach - Other
Eligibility
18+
All Sexes
Eligible conditions
Head Neoplasms

Study Summary

This study is evaluating whether a mobile app can help patients with head and neck cancer adhere to their treatment plan.

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Eligible Conditions

  • Head Neoplasms
  • Head and Neck Neoplasms
  • Head Neck Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Virtual Coach will improve 1 primary outcome and 6 secondary outcomes in patients with Head Neoplasms. Measurement will happen over the course of up to 7 weeks.

7 weeks
Depth of bolus entry into the laryngeal vestibule as measured using the Penetration-Aspiration Scale (PAS)
Diet level as defined by the Functional Oral Intake Scale
Diet restrictions as measured by the Performance Status Scale Head and Neck
Patient perceived swallowing impairment as measured by the MD Anderson Dysphagia Inventory
Physiological oropharyngeal swallowing impairment as measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
Severity of impairment of swallowing safety and efficiency as measured using the Dynamic Imaging Grade of Swallowing Toxicity scale
up to 7 weeks
Overall adherence to prescribed exercise protocol measured as percentage of prescribed exercises completed

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Virtual Coach App

This trial requires 176 total participants across 2 different treatment groups

This trial involves 2 different treatments. Virtual Coach is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Virtual Coach App
Other
Participants in the experimental arm (Group A) will receive a comprehensive swallowing rehabilitation app. This study seeks to determine if a mobile application may enhance adherence to swallowing therapy in patients undergoing radiation therapy for head and neck cancer. No devices - outside of the Smartphone already owned by the participant - will be used in this study. Similarly, no drugs, biological materials, or other substances will be used.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 weeks for reporting.

Closest Location

Massachusetts Eye and Ear Infirmary - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Head Neoplasms or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive course of radiotherapy requiring a prescribed dose of 60Gy or greater.
Study subjects ≥ 18 years of age.
Fluent English speaking subjects.
Study subjects capable of providing informed consent.
Patients with newly diagnosed non-metastatic head and neck cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, and larynx that require bilateral neck radiation. Individuals with unknown primary head and neck cancer with nodal disease necessitating bilateral radiation will also be included.
Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the Vibrent application.
Study subjects who have access to a sufficient monthly data plan (approximately 200 MB/month), or Internet connection.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for head neoplasms?

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The treatment strategies of head neoplasms consist of many types of surgical intervention, radiation therapy, chemotherapy, and targeted medication therapy. There are different treatment options that can be selected for treatment depending on individual factors of the patients, comorbidities, and tumor sites. The combination chemotherapy regimen including fluoropyrimidine and vincristine is the first-line treatment in some patients; meanwhile, radiotherapy plus chemotherapy is the second-line treatment in some patients.

Unverified Answer

What is head neoplasms?

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Head neoplasms are a common cause of significant morbidity and mortality, primarily due to their impact on facial appearance and functionality. Although many head neoplasms are benign, the more aggressive head brain tumor types can have significant negative effects on facial and life quality.

Unverified Answer

What causes head neoplasms?

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answer: A causal association between herpes simplex virus infection, use of acyclovir or the use of cidofovir and herpes labialis, human papillomaviruses, use of acyclovir and the use of cidofovir with warts and the incidence of head and neck cancer could not be demonstrated.

Unverified Answer

Who should consider clinical trials for head neoplasms?

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All patients should receive full clinical information and discuss and approve clinical trial results, as they will greatly help make their own healthcare decisions. Those with neurological deficits and who are unable to make medical decisions for care and treatment after a brain tumor diagnosis are those most likely to benefit from clinical trial treatment.

Unverified Answer

Have there been other clinical trials involving virtual coach?

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Given the successful pilot study of this novel virtual coach system, and its potential for future enhancements, we believe that virtual coach may be an ideal and valuable method to study cancer rehabilitation in future randomized clinical trial, and to teach medical students about cancer rehabilitation.

Unverified Answer

How many people get head neoplasms a year in the United States?

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There is no estimate of the number of people who get head neoplasms with certainty. Based on the reported incidence of head or neck cancers, it is estimated 3,000 people die in the United States each year from head and neck neoplasms.

Unverified Answer

Can head neoplasms be cured?

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Some common neoplasms can be totally curable when first diagnosed. However, given the difficulty in diagnosing some neoplasms, treatment for the disease remains a challenge, even for specialists.

Unverified Answer

What are the signs of head neoplasms?

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The main signs and symptoms of head neoplasms are usually vague and nonspecific, and nonspecific clinical tests are often needed before the correct diagnosis of these lesions. Diagnostic procedures for head neoplasms including CT scanning and PET/CT scans, need to be more frequently performed on cases of unknown origin.

Unverified Answer

How quickly does head neoplasms spread?

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Despite the rarity of head neoplasms, their rapid progress is often detected by early imaging techniques. This may lead to early referral for treatment. Head CT is the main modality for imaging head cancers and the main tool for detecting early stages.

Unverified Answer

How serious can head neoplasms be?

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Primary [brain tumor](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/brain-tumor)s are much more common and more serious than previously thought, and the overall five-year survival rate is only about 50%. The most common malignancy of CNS are astrocytomas (about 40%), followed by ependymomas (about 19%). When a tumor is found, it should be removed by surgical resection for diagnosis and treatment, because chemotherapy has not been shown to be effective. Patients who have a glioma in a second location, especially of a brainstem location, also have poor five-year survival. Most survivors have symptomatic symptoms and need treatment. The best method of diagnosing a brain tumor is by using scans and blood samples.

Unverified Answer

What are the latest developments in virtual coach for therapeutic use?

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Data from a recent study of this study demonstrate that it has not yet been found the best option for a virtual coach, but it may show clinical utility in improving adherence to treatment. In addition, using virtual coaches may enhance the quality of patient care and lead to cost savings among health plans.

Unverified Answer
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