AzTrials
AzTrials

Head Neck CancerNCT03832686

Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer

A study testing Virtual Coach in people with Head Neck Cancer, run by Stanford University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head Neck Cancer
What is being tested?
Virtual Coach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
3 sitesUnited States
Study dates
22 Apr 2019to 6 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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 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.

Who cannot join

  • Non-English speaking, or incapable of providing informed consent.
  • Lack of smartphone, tablet, or Internet connection.
  • Inability to use the Vibrent application.
  • Patients being treated for head and neck cancer who do not receive some form of primary, adjuvant, or neo-adjuvant radiation therapy will not be considered for the study.
  • Patients with recurrent disease.
  • Pregnant women.
  • Individuals under the age of 18.
  • Individuals with contraindications to radiation therapy.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02114

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer.

Read the detailed description

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has recently seen a dramatic rise in the United States due to a rise in the incidence of oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients diagnosed with HNC receive radiation therapy at some point in their treatment, either in the definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC, experienced by approximately 50% of patients treated with radiation therapy. Post-treatment dysphagia has been associated with increased risk of morbidity/mortality as well as well-recognized deterioration of quality of life. Performance of swallowing exercises during radiation significantly reduces dysphagia risk; however, patient adherence to swallowing exercises during radiation treatment is limited. Thus, poor adherence stands as a major obstacle to achieving the best swallowing outcomes. In response to this, a mobile health application was developed to directly address barriers cited by patients as reasons for non-adherence. The objective is to conduct a randomized controlled trial to test the impact of the mobile application on adherence to prophylactic swallowing therapy during radiation for HNC.

Being tested
Virtual Coach
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual CoachOther

    The smartphone application, tailored to patients with HNC, will monitor patient progress while also providing a direct line to health care providers should any questions or concerns arise concerning their treatment. The mobile application will also feature instructional videos that describe the swallowing exercises in detail, providing patients with another resource to help improve their overall rehabilitation experience. Finally, home practice reminders and prompts will be used to help patients integrate the exercises into their daily routine.

Study groups in NCT03832686
Study groupRoleWhat they receive
Virtual Coach AppExperimentalParticipants 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.
Receives: Other: Virtual Coach
Standard of CareNo interventionThe paper group (Group B) will be given paper exercise logs to fill out Participants will be educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP. The paper log treatment group will serve as a standard treatment group. As adherence is a primary goal of the target intervention, paper logging will be necessary to determine relative adherence while minimizing reporting bias.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises

    Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week.

    Measured: 7 weeks

Secondary outcomes (6)

  1. Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)

    The MD Anderson Dysphagia Inventory (MDADI) was selected to capture and quantify the patient perception of swallowing dysfunction. It is a 20-item patient reported survey that measures the impact of dysphagia on patients with HNC. Each item is scored on a 5 point scale with 1=lower function and 5=higher function. Possible scores range from 20-100 with higher scores indicating more normal swallowing function.

    Measured: 19 weeks

  2. Diet Level as Defined by the Functional Oral Intake Scale (FOIS)

    Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 where lower scores reflect more limited oral intake and higher scores reflect more normal diet levels.

    Measured: 19 weeks

  3. Diet Restrictions as Measured by the Performance Status Scale Head and Neck

    Performance Status Scale Head and Neck measures eating in public (range 0-100; higher number is indicative of better function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)

    Measured: 7 weeks

  4. Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)

    The Modified Barium Swallow Impairment Profile is a tool designed to quantify degree of impairment on 13 individual physiologic components visualized during a modified barium swallow where higher numbers reflect greater dysfunction. Score range: 0-4 for each physiologic component. The maximum possible Oral score is 22 and the maximum possible pharyngeal score is 29.

    Measured: 19 weeks

  5. Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)

    The Penetration Aspiration Scale measures the presence and depth of food/liquid material entering the airway and patient response to that material. This scale ranges from 1-8 with higher numbers indicating more abnormal function.

    Measured: 19 weeks

  6. Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale

    Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) rates the safety and efficiency of the swallow. Safety and efficiency are rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale also includes an overall impairment score which takes into consideration the safety and efficiency grade.

    Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2019
  2. Study start22 Apr 2019
  3. Primary completion3 Mar 2022
  4. Study completion6 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03832686
Sponsor's protocol ID
IRB-48015
Other IDs
ENT0070, NCI-2019-04958
Status last verified
Apr 2024
First submitted
28 Jan 2019
Last updated
10 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Starmer HM, Klein D, Montgomery A, Goldsmith T, McCarroll L, Richmon J, Christopher Holsinger F, Beadle B, Jain P. Head and Neck Virtual Coach: A Randomized Control Trial of Mobile Health as an Adjunct to Swallowing Therapy During Head and Neck Radiation. Dysphagia. 2023 Jun;38(3):847-855. doi: 10.1007/s00455-022-10506-5. Epub 2022 Aug 12.

    PubMed 35960394

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Coach in people with Head Neck Cancer, run by Stanford University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03832686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in