Validation of Smartphone App for Head and Neck Cancer Control and Patient Support
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|ClinicalTrials.gov Identifier: NCT03832686|
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head Neck Cancer||Other: Virtual Coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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
- 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
- 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
- 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)
- 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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03832686
|Contact: Nikita Bediemail@example.com|
|United States, California|
|Stanford Cancer Institute||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Nikita Bedi 650-723-5957 firstname.lastname@example.org|