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Validation of Smartphone App for Head and Neck Cancer Control and Patient Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03832686
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : January 6, 2020
Stanford University
Johns Hopkins University
Massachusetts General Hospital
Information provided by (Responsible Party):
Vibrent Health

Brief 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.

Condition or disease Intervention/treatment Phase
Head Neck Cancer Other: Virtual Coach Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Validation of Cancer Prevention, Control and Intervention RCT With Smartphones, Cognitive Computing & Family Social Support
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Virtual Coach App
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.
Other: Virtual Coach
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.

No Intervention: Standard of Care
The 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.

Primary Outcome Measures :
  1. Overall adherence to prescribed exercise protocol measured as percentage of prescribed exercises completed [ Time Frame: up to 7 weeks ]
    Percentage of prescribed exercises completed over a 7-week treatment period

Secondary Outcome Measures :
  1. Patient perceived swallowing impairment as measured by the MD Anderson Dysphagia Inventory [ Time Frame: 7 weeks ]
    Mean MD Anderson Dysphagia Inventory score by treatment group

  2. Diet level as defined by the Functional Oral Intake Scale [ Time Frame: 7 weeks ]
    Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 with higher numbers indicating more normal diet

  3. Diet restrictions as measured by the Performance Status Scale Head and Neck [ Time Frame: 7 weeks ]
    Performance Status Scale Head and Neck provides a measure of eating in public (range 0-100; higher number is indicative of better function), understandability of speech (range 0-100, higher number is indicative of more normal function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)

  4. Physiological oropharyngeal swallowing impairment as measured by the Modified Barium Swallow Impairment Profile (MBS-ImP) [ Time Frame: 7 weeks ]
    Mean composite Modified Barium Swallow Impairment Profile score by treatment group

  5. Depth of bolus entry into the laryngeal vestibule as measured using the Penetration-Aspiration Scale (PAS) [ Time Frame: 7 weeks ]
    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.

  6. Severity of impairment of swallowing safety and efficiency as measured using the Dynamic Imaging Grade of Swallowing Toxicity scale [ Time Frame: 7 weeks ]
    Dynamic Imaging Grade of Swallowing Toxicity rates the safety and efficiency of the swallow. Each parameter is rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale includes the safety score, the efficiency score, and an overall impairment score which takes into consideration the safety and efficiency grade.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03832686

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Contact: Nikita Bedi 650-723-5957

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United States, California
Stanford Cancer Institute Recruiting
Palo Alto, California, United States, 94304
Contact: Nikita Bedi    650-723-5957   
Sponsors and Collaborators
Vibrent Health
Stanford University
Johns Hopkins University
Massachusetts General Hospital

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Responsible Party: Vibrent Health Identifier: NCT03832686    
Other Study ID Numbers: HHSN261201700003C_SBIR342
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site