Swallowing Therapy With the Assistance of a Mobile Health Device in Head and Neck Cancer Patients: a Pan-Alberta Study

NCT04698499 | Completed DMC

• 1 other identifier: HREBA.CC-21-0054
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Dysphagia affects 22% of those over the age of 50, which equates to 250 million people worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%). Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. To regain swallowing function and avoid or reduce the consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it. The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated. Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in the study. This study will follow a cross over randomized design such that all participants will be provided with both types of treatment: using pen and paper (Treatment Arm A) and using the mobile health system (Treatment Arm B).

Conditions

Dysphagia; Head and Neck Cancer

Keywords

Adherence; Remote care

Outcome Measures

Primary Outcomes (4)

• Percent adherence to recommended number of exercises

  Daily adherence logs will be collected via diary forms completed using pen and paper for Treatment Arm A. For Treatment Arm B, daily adherence logs will be collected remotely, by the Mobili-T system Adherence can range from 0% (no adherence) to 100% (best adherence).

  The duration of the trial, up to approximately 13 weeks

• Change in the MD Anderson Dysphagia Inventory (MDADI)

  Patient questionnaire The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of head and neck cancer. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Scores are summed, and a mean score is calculated. This mean score is multiplied by 20 to obtain a score with a range of 0 (extremely low functioning) to 100 (high functioning).

  Basline (Pre-treatment)

• Change in the MD Anderson Dysphagia Inventory (MDADI)

  Patient questionnaire The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of head and neck cancer. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Scores are summed, and a mean score is calculated. This mean score is multiplied by 20 to obtain a score with a range of 0 (extremely low functioning) to 100 (high functioning).

  6 weeks post-baseline

• Change in the MD Anderson Dysphagia Inventory (MDADI)

  Patient questionnaire The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of head and neck cancer. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Scores are summed, and a mean score is calculated. This mean score is multiplied by 20 to obtain a score with a range of 0 (extremely low functioning) to 100 (high functioning).

  13 weeks post-baseline

Secondary Outcomes (6)

• Three-Day Dietary Intake Record

  Baseline (Pre-treatment)

• Three-Day Dietary Intake Record

  6 weeks post-baseline

• Three-Day Dietary Intake Record

  13 weeks post-baseline

• The Health Questionnaire (EuroQoL EQ-5D)

  Baseline (Pre-treatment)

• The Health Questionnaire (EuroQoL EQ-5D)

  6 weeks post-baseline

Study Arms (2)

Pen and Paper

ACTIVE COMPARATOR

Participants will complete swallowing exercises using printed materials and diary for tracking.

Other: Swallowing exercise from home

Mobile health system

EXPERIMENTAL

Participants will complete swallowing exercises using a mobile health system with surface electromyography (sEMG) biofeedback.

Other: Swallowing exercise from home

Interventions

Swallowing exercise from home OTHER

Treatment Arm A will consist of using pen and paper to complete the exercises. This is considered standard care. Treatment Arm B will consist of using Mobili-T to complete the exercises.

Mobile health system; Pen and Paper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prior diagnosis of oropharyngeal dysphagia secondary to treatment for squamous cell carcinoma (OPSCC)
• months or later post-surgery or post-(chemo)radiation therapy
• received treatment for head and neck cancer (e.g., +/-surgery, +/-radiation therapy, +/- chemotherapy)
• attending speech-language pathologist has confirmed from a Modified Barium Swallow (MBS) assessment or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) that the patient is a candidate for the effortful swallow and/or the Mendelsohn maneuver therapy.

You may not qualify if:

• have a history of cognitive delay (patient or SLP reported)
• have a history of stroke or traumatic brain injury (patient or SLP reported)
• cannot reliably navigate the Mobili-T system after the training session
• attending SLP confirms planned swallowing exercises or procedures to address dysphagia like esophageal dilation
• have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators
• have irritated skin or skin with open wounds under the chin
• have an allergy to silver
• have a beard or not willing to shave or partially shave
• unable to travel to Edmonton 3 times during a 3 month period

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Cancer Foundation: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Jana Rieger, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 7, 2021
• Study Start: October 27, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)