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

Summary

Participation Requirements

Description

Background 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%), stroke patients (78%), people with Parkinson's disease (82%) and those who've had a traumatic brain injury (65...

Background 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%), stroke patients (78%), people with Parkinson's disease (82%) and those who've had a traumatic brain injury (65%). Left untreated, dysphagia has serious health consequences, such as malnutrition, aspiration pneumonia, and even death. The associated longer hospital stays and complications result in an estimated annual burden of care of $547 billion in USA. In Alberta, managing just one consequence of dysphagia (aspiration pneumonia) in patients with head and neck cancer and stroke cost the healthcare system $2.53 million CAD a year. Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. Patients with dysphagia avoid social situations that involve eating, are disproportionately affected by depression, and miss more than 3 times the number of workdays than individuals without swallowing difficulties. To regain swallowing function and avoid or reduce the aforementioned 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). sEMG biofeedback lets patients know how hard their muscles are contracting and for how long during a given exercise. sEMG biofeedback is used to teach patients how to perform exercises correctly, elicit maximum effort, and demonstrate incremental improvements in performance. Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it. This limited access stems from poor patient and clinician resources. For patients, getting to the clinic to access a clinician and the equipment is inconvenient and costly. In our clinic, the investigators estimated that only 10% of patients who would benefit from one-on-one in-clinic therapy actually came in for it. In order to cope with limited patient engagement, clinicians are more likely to manage dysphagia by providing diet modifications, by prescribing feeding tubes, and by giving patients maneuvers and exercises on a printed sheet of paper. First, these approaches to the management of dysphagia are inadequate to meet the needs of patients. Furthermore, a recent systematic review found that average adherence to dysphagia management recommendations was between 22% and 52%. Second, there will never be enough trained clinicians to meet the global need for swallowing rehabilitation. Few clinicians have the equipment needed or the time to see patients with the intensity and consistency required for improvement. This means that the solution must be mobile, must scale exponentially, and must avoid the human and resource bottleneck. Mobile swallowing therapy system The Mobili-T is a mobile swallowing therapy system that provides equitable access to therapy for patients with swallowing difficulties. Mobili-T allows patients to reliably complete their prescribed intensive swallowing therapy on a daily basis, from the comfort of their own home, all while still being connected to a clinician. The Mobili-T system is comprised of a mobile device, a smartphone patient app, proprietary software, and a clinician portal. The patient wears the mobile device during exercise. The mobile device uses clinical grade surface electromyography (sEMG) and sticks under the chin with an adhesive. The sEMG hardware comes with a charging dock that doubles as a carrying case. The sEMG signal is wirelessly transmitted to the smartphone app. Here, the sEMG is shown to the patient customer as visual biofeedback, where the deflection of the biofeedback signal reflects the strength and duration of muscle contraction. The muscles monitored are found under the chin (submental area) and are those targeted during swallowing rehabilitation. The app uses a smart software that walks patients through a set of clinically proven swallowing exercises, uses a back-end algorithm to detect whether or not the sEMG signal collected was elicited by a swallow (as opposed to other extraneous movements such as head movements), and calculates effort targets based on the patient's abilities. Clinicians can remotely monitor patient progress, adherence, and adjust prescriptions. One of the unique aspects of Mobili-T is that the investigators have involved patients and clinicians in the design from the inception of the project. The investigators also have conducted usability and feasibility research testing. Our first study was a feasibility trial with 20 patients with dysphagia secondary to head and neck cancer (submitted). The investigators evaluated whether or not patients could successfully complete swallowing therapy using the Mobili-T at home under the remote clinical supervision of our speech language pathologist. The investigators found that patients successfully used Mobili-T. Our results also showed that patients reported improved swallowing, improved confidence when eating, shorter mealtimes, and increased selection of food options. Next, the investigators will conduct a pan-Alberta trial with head and neck cancer patients with the aims stated below. Adherence and Swallowing outcomes research hypotheses: Hypothesis 1. Adherence for swallowing therapy will be higher when using the Mobili-T system than when using the standard of care recommendations (pen and paper): as measured by diary format and objective data capture from the Mobili-T system Hypothesis 2. Swallowing outcomes, as measured by patient self-perception, will see the greatest change from pre- to post-therapy in patients who have high treatment adherence. Economic outcomes research hypotheses: Hypothesis 3. As a group, head and neck cancer patients will span all socioeconomic circumstances; however, sustained weekly adherence of 80% or higher to therapy will be associated with a higher socioeconomic subgroup. The cost of administering swallowing therapy remotely will be estimated. General study details for ITA A total for 60 patient participants will be recruited, 30 per study arm. The study will last 3 months and one week (or 13 weeks). However, the study will remain open until all participants have been recruited and have completed the trial (expected to take 1 year). Participants 1.1 Recruitment. Participants will be recruited at the University of Alberta Hospital, Cross Cancer Institute, Institute for Reconstructive Sciences in Medicine, and Home Nutrition Support Program, Foothills Medical Center, Tom Baker Cancer Center and Central Alberta Cancer Center. Participants will be identified by their physicians or speech-language pathologists (SLPs). Participants also will be recruited from a pool of individuals who have contacted the research team during the feasibility trial or following media events, wishing to be notified about upcoming trials. 1.2 Inclusion/ Exclusion Criteria. Participants will be enrolled in the study if they have a diagnosis of oropharyngeal dysphagia secondary to treatment for squamous cell carcinoma (OPSCC). SCCs make up 90% of all HNCs. Participants will be consecutively recruited, until the sample size is achieved. Participants will be recruited any time 3 months or later post-surgery or post-(chemo)radiation therapy. This time frame was selected to avoid duplication of services for patients who may receive swallowing therapy during their radiation therapy and to target patients with chronic and stable dysphagia. Participants will be included: 1) if they have received treatment for head and neck cancer (e.g., +/-surgery, +/-radiation therapy, +/- chemotherapy), 2) if their attending speech-language pathologist has confirmed from a Modified Barium Swallow (MBS) assessment that the patient is a candidate for the effortful swallow and/or the Mendelsohn maneuver therapy. These exercises target specific physiological impairments of the swallow that are common to OPSCC patients. Participants will be excluded: 1) if they have a history of cognitive delay, 2) a history of stroke or traumatic brain injury, and 3) if they cannot reliably navigate the Mobili-T system after the training session. Participants also will be excluded if they have a beard that they are not willing to shave or partially shave (as the device adheres under the chin, on the surface of the skin). Finally, participants will be excluded if they are unable to travel to Edmonton 3 times during a 3 month period). 1.3 Sample Size. The investigators used a previous study to guide our sample size selection. In the cited study, a total of 79 OPSCC patients were randomized to 3 treatment arms (26 or 27 patients participants per arm), where one of the treatment arms included swallowing therapy using an app. As the present study has 2 treatment arms, the investigators will recruit 52 to 60 participants. 2.0 General Procedure: 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 the mobile health system and using pen and paper. Randomized allocation will be determined using Sealed Envelope, a Randomization and online database for clinical trials (https://www.sealedenvelope.com/) Once a patient expresses interest in the study/ is referred to the study by their clinician (e.g., SLP), the clinician researcher on this study, Dr. Gabi Constantinescu, will contact the participants with more information and screening questions. An electronic or hard copy version of the Letter of Information and Consent form will be shared with the patient. The information and questions are meant to ensure that patients interested in the study fit most exclusion/ inclusion criteria before traveling to Edmonton. Consent will be obtained before participants are invited to Edmonton for their first appointment. The patient's attending SLP will be contacted to ensure that services are not duplicated elsewhere, that the patient is not booked for other procedures that may impact outcomes in this trial (e.g., esophageal dilation), that a swallow assessment was not recently completed and that the SLP believes the patient will be a good candidate for the swallowing therapy offered through this study. If the patient participant's Modified Barium Swallow (MBS) is available on ConnectCare, it will be further reviewed by the study team. All pre-, washout, and post-treatment sessions will take place in Edmonton. 2.1 Pre-treatment session. The Letter of Information and Consent will be reviewed again. The MD Anderson Dysphagia Inventory (MDADI) and a Socioeconomic Status questionnaire (both described in section 3.0 Outcome Measures) will be administered. Next, Dr. Constantinescu will: (1) determine the order of treatment blocks for the participant (i.e., Group1, or Group 2); (2) introduce the Mobili-T system (if applicable); (3) introduce the swallowing exercises and allow time for practice; (4) explain the treatment block format and associated documents. The swallowing therapy exercises will be explained and practiced until patients can demonstrate competency on their own. This ability is defined as the successful completion of five consecutive trials of each exercise, where the success will be judged by clinical visual inspection. Participants will be sent home with the Three-Day Dietary Intake Record to complete and return. Clinician(s) in this study (i.e., SLP research associate) will remotely monitor the session data sent by patient participants and will be available to answer questions and troubleshoot technology issues. Again, data will only include the number on the hardware, not patient identifiers. If patient participants are randomized to the Treatment Arm with the Mobili-T system, then training with the Mobili-T will conclude once the patient appears comfortable with the device, has shown that he/ she can set up the device and start the software independently, and has demonstrated competency with the exercises. Patients will not be identified on the device, app, or clinician portal. The app simply records the serial number on the device hardware (e.g., 001). This is noted in the researcher's records (e.g., J Smith - 001). 2.2 Treatment blocks A and B. Patients will be asked to practice at home for 3 months targeting a daily total of 8 sets of 3 exercise types with 3 repetitions of each. The daily total target will be 72 trials (8 sets * 3 exercise types * 3 repetitions of each). Exercise type and dose will be the same for all participants, for a daily total of 24 regular saliva swallows, 24 effortful saliva swallows, and 24 Mendelsohn maneuver saliva swallows. 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. 2.3 Post-treatment session. Following the first Treatment Arm, there will be a one week washout period. During this week, as well as following the second Treatment Arm, a post-treatment session will be booked and the Three-Day Dietary Intake Record provided for home completion. This session will consist of administering the MDADI, a patient treatment-attributable costs survey, and either returning or providing the Mobili-T system.

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