Neoplasms

All Conditions

Head and Neck Neoplasms

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.

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.

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.

Virtual Coach

Heather Starmer

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.

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.

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

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

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.

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.

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)

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.

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.

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.

National Cancer Institute (NCI)

Stanford University

Clinical Associate Professor and Director of the Head and Neck Cancer Speech and Swallowing Rehabilitation Center

Per protocol, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.

Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.

Virtual Coach App

Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.

Standard of Care

Total

Age, Continuous

Female

Male

Unknown/Not Reported

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Heather Starmer, MD

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Participants with available data at each respective timepoint.

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

Participants who completed the intervention and were blinded at consent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer	NCT03832686	Head Neck Cance...	Virtual Coach	18 Years -	Stanford University
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer	NCT03832686	Head Neck Cance...	Virtual Coach	18 Years -	Stanford University

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