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

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.

Study Overview

• Status: Completed
• Conditions: Head Neck Cancer
• Intervention / Treatment: Other: Virtual Coach

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Dana-Farber Cancer Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	19 weeks
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.	19 weeks
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)	7 weeks
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.	19 weeks
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.	19 weeks
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.	7 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heather Starmer, Stanford Universiy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: IRB-48015; ENT0070 (Other Identifier: OnCore); NCI-2019-04958 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No