Virtual Group Speech Therapy for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Disqualifiers: Metastases, Laryngectomy, Dysphagia, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This project aims to study an innovative intervention, the eG2 Intervention, developed by speech-language pathologists at the Centre hospitalier de l'Université de Montréal to improve therapeutic adherence and prevent dysphagia in patients treated with chemoradiotherapy for head and neck cancer.
The innovation consists in offering a speech therapy intervention that is 1) virtual, 2) group-based (whereas it is usually individual) and 3) involves a patient partner. This intervention has the potential to improve quality of care, accessibility to services and optimize health care resources.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.
What data supports the effectiveness of the treatment Virtual Group Speech Pathology Intervention for head and neck cancer?
The research indicates that speech pathology services, which include interventions like the Virtual Group Speech Pathology Intervention, can help improve speech and swallowing functions in patients after head and neck cancer treatment. This is supported by data showing optimal recovery of these functions at six months post-treatment, suggesting that such interventions can be beneficial.
12345Is virtual group speech therapy safe for head and neck cancer patients?
There is no specific safety data available for virtual group speech therapy in head and neck cancer patients, but general safety concerns for online speech therapy include potential voice strain for therapists, which suggests the need for careful monitoring and prevention strategies.
26789How is the Virtual Group Speech Pathology Intervention different from other treatments for head and neck cancer?
The Virtual Group Speech Pathology Intervention is unique because it uses a group setting to help patients practice and apply new speech techniques in a supportive environment, which may enhance the generalization of skills to everyday communication. Additionally, it is delivered virtually, improving access for patients who may face barriers to in-person therapy.
1011121314Eligibility Criteria
Adults over 18 with head or neck cancer starting chemoradiotherapy for cure can join. They need a radiation dose of at least 60 Grays and must speak French well enough for questionnaires. Those with distant cancer spread, planned total laryngectomy, prior severe swallowing issues, another simultaneous cancer, previous head/neck radiation, or significant cognitive impairments cannot participate.Inclusion Criteria
My radiation therapy is planned to be 60 Grays or more.
I am 18 or older with head or neck cancer.
I am scheduled for chemoradiotherapy aimed at curing my condition.
+1 more
Exclusion Criteria
I have had serious swallowing problems checked by a speech therapist.
I have been diagnosed with another cancer at the same time as my current one.
I have had radiation therapy to my head or neck.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemoradiotherapy
Participants receive chemoradiotherapy treatment for head and neck cancer
6 weeks
Virtual Group Speech Therapy
Participants engage in a virtual, group-based speech therapy intervention guided by a patient partner
Concurrent with chemoradiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of nasogastric tube placement
6 weeks
Participant Groups
The trial is testing the eG2 Intervention: a virtual group speech therapy guided by a patient partner to prevent swallowing difficulties in patients undergoing chemoradiotherapy for head and neck cancers. It aims to improve care quality and accessibility while optimizing healthcare resources.
1Treatment groups
Experimental Treatment
Group I: virtual group speech therapy intervention guided by a patient partnerExperimental Treatment1 Intervention
Virtual Group Speech Pathology Intervention is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as eG2 Intervention for:
- Prevention of dysphagia in patients treated with chemoradiotherapy for head and neck cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Hospitalier de l'Université de MontréalMontréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
Université du Québec à Trois-RivièresCollaborator
References
An evaluation of functional outcomes (speech, swallowing) in patients attending speech pathology after head and neck cancer treatment(s): results and analysis at 12 months post-intervention. [2006]We have earlier reported establishing a computerized database to audit functional outcomes in patients who underwent head and neck cancer treatment in Victoria, Australia and attended speech pathology services from April 1997-April 1999. This paper presents the statistical analyses and results from this study. Speech pathologists collected, prospectively, functional outcome data on 293 patients who underwent head and neck cancer treatment, and sent these for analysis to La Trobe University. Clinician and patient assessments of outcomes: speech, swallowing, activity, pain, employment, health, QOL status were made. Initial data on 293 patients were collected and data on mortality and morbidity were compiled at three, six and 12 months post-treatment. Within twelve months, 74 patients had died. Three, six and/or 12-month follow-up data was available on 219 patients, with both clinician and patient assessments of status completed. The status forms are presented as appendices to this paper. Complete status forms on 179 patients at 12 months were obtained. This clinical audit of functional outcomes represents the first study of this kind, collecting data from speech pathologists and patients in a multi-centre study of patients with head and neck cancer. We present data to demonstrate optimal recovery of function at six months, such that this may represent a good reference point for reporting and comparison of functional outcomes.
Computerized monitoring of patient-reported speech and swallowing problems in head and neck cancer patients in clinical practice. [2021]The purpose of this study is to evaluate computerized monitoring of speech and swallowing outcomes and its impact on quality of life (QoL) and emotional well-being in head and neck cancer patients in an outpatient clinic.
Outcomes of an Advanced Speech and Language Therapist-Led Low-Risk 2-Week Wait Clinic for Suspected Head and Neck Cancer: A UK-Based Pilot Study. [2023]To describe outcomes of a pilot Speech and Language Therapist led (SLT-led) 2-week wait (2WW) assessment clinic for head and neck cancer (HNC).
Evaluation of functional outcomes (speech, swallowing and voice) in patients attending speech pathology after head and neck cancer treatment(s): development of a multi-centre database. [2019]Since April 1997, in Melbourne, Australia, speech pathologists have collaborated to establish a prospective database of functional outcomes of speech, swallowing and voice for patients undergoing head and neck cancer treatments. Staff at eight acute care hospitals, all of which offer speech pathology for head and neck cancer services in Victoria, are contributing data, collated centrally, in an agreed pro forma. Early results are given (after 12 months' data collection). The implications for clinically-based research, and the future potential for benchmarking outcomes--by expansion of the rehabilitation database beyond the current participating sites--is discussed. This paper outlines the rationale of establishing the database is multicentered, and explores some of the complexities involved, including the challenges inherent in long-term accurate data collection in the head and neck cancer patient population. This work represents the development of an appropriate, usable tool for data collection on functional outcomes.
Speech pathology service enhancement for people with head and neck cancer living in rural areas: Using a concept mapping approach to inform service change. [2021]Speech pathology (SP) services provide swallowing and communication intervention to people with head and neck cancer (HNC) across the continuum of care. However, difficulties exist with access and delivery of services in rural areas. The study aim was to identify actionable goals for SP change, utilizing a concept mapping approach.
Muscle Tension Dysphonia: A Sequeale of Chemoradiotherapy in Patients of Head and Neck Cancer. [2023]It's very important to demarcate that voice is the production of sound by the larynx while speech is articulation of the produced sound by tongue movements, soft palate and the lips. Mucositis, dysphagia, change in speech and voice are the common sequelae of Radiotherapy (RT) alone or in combination with chemotherapy (CRT) which is commonly used in the treatment of head and neck cancer (HNC). The aim of this study was to investigate the patient-reported voice impairment among non laryngeal head and neck cancer survivors who were treated with curative RT/CRT with or without surgery. This tertiary institutional assessor blinded study consists of a study cohort of 128 patients who after of completion of treatment for HNC reported to the laryngology clinic for voice complaints and throat discomfort. The assessment included laryngeal endoscopic and stroboscopic imaging, acoustics assessment and VHI (Vocal handicap index). This study cohort consisted of 89.8% males and 11.2% females. There was hyperadduction and strain of ventricular bands in almost all the cases. There was hyperactivity and compression of both true and false cords in 80.5% of the cases. DSI impairment level showed significant association with gender, VHI, GRBAS score and RT/CRT and it did not show significant association with smoking and surgery, while VHI showed significant association with DSI and RT/CRT and it did not show significant association with gender, smoking and surgery. Muscle tension is a very common effect of RT/RCT and dysphonia can be easily associated with it. Future research needs to focus on specific voice treatment regimens in HNC treated with RT/CRT to improve the quality of life of these patients.
Phonogenic Voice Problems among Speech-Language Pathologists in Synchronous Telepractice: An Overview and Recommendations. [2021]Many speech-language pathologists (SLPs) recently adopted a live, synchronous online distribution of clinical services due to physical distancing measures aimed at bringing the coronavirus disease 2019 (COVID-19) outbreak under control. Few SLPs had received training in telepractice to prepare them for changes from an in-person service delivery model to synchronous telepractice. The new telepractice environment may alter vocal behaviors and communication interactions in such a way that negatively impacts voice production. Thus, delivering synchronous online clinical services may require that SLPs adopt novel prevention strategies for avoiding phonogenic voice problems. Guided by two complementary injury frameworks, the Haddon Matrix and the Haddon Countermeasures, this article provides an overview of potential factors associated with phonogenic voice problems among SLPs in telepractice and proposes possible prevention strategies to maintain optimal vocal health and function with synchronous modes of online clinical practice.
Relating speech and swallow function to dropout in a longitudinal study of head and neck cancer. [2007]The relation between functional outcome and dropout from a 12-month follow-up period was examined in a longitudinal study whose objective was to define and quantify the functional effects of oral surgical resection and reconstruction on speech and swallowing in patients with head and neck cancer. In a group of 150 patients recruited to a surgical study in the Cancer Control Science Program in Head and Neck Cancer Rehabilitation, dropout from all causes and dropout from specific causes (medical, patient, and administrative specific) were assessed in relation to longitudinal speech and swallow function. In univariate analysis, better speech articulation was associated with decreased risk of dropout from all causes and from medical-specific causes. Better swallow performance was associated with decreased risk of medical-specific dropout. Multivariate analysis revealed the following: (1) only articulation function was associated with dropout from all causes; (2) the association of speech articulation function with medical dropout was diminished after adjusting for advanced age and surgical resection variables; (3) the association of speech articulation function became significant for patient-specific dropout after adjusting for advanced age and surgical resection variables and indicated that better function decreased the risk of this type of dropout; and (4) swallowing function was not related to dropout. Patients treated for oral or oropharyngeal cancer who have poorer speech outcomes are more likely to drop out from a longitudinal study. Basing study results on only patients who complete a longitudinal study will understate the level of dysfunction experienced.
The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer. [2022]Patients with head and neck cancer (HNC) experience painful, debilitating symptoms and functional limitations that can interrupt cancer treatment, and decrease their health-related quality of life (HRQoL). The Electronic Patient Visit Assessment (ePVA) for head and neck is a web-based mHealth patient-reported measure that asks questions about 21 categories of symptoms and functional limitations common to HNC. This article presents the development and usefulness of the ePVA as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC.
Effects of Voice Therapy: A Comparison Between Individual and Group Therapy. [2018]The primary aim of this clinical evaluation project is to study the effect of voice therapy given in the speech-language pathology clinic, as individual and group therapy, as well as finding out some of the reasons for not attending the recommended therapy.
Application of telepractice for head and neck cancer management: a review of speech language pathology service models. [2018]Head and neck cancer (HNC) is a complex and heterogeneous disease, requiring specialist intervention from a multidisciplinary team including speech language pathology (SLP). Unfortunately, multiple patient and service-related challenges exist which currently limit equitable access to SLP support for all individuals. This review highlights the existing evidence for different telepractice models designed to help patients and services optimize management of swallowing and communication disorders arising from HNC.
Home-based speech treatment for Parkinson's disease delivered remotely: a case report. [2022]We investigated the validity and feasibility of online delivery of the Lee Silverman Voice Treatment (LSVT) for the treatment of the speech disorder of a patient with idiopathic Parkinson's disease. The treatment was delivered in 16 sessions to the participant's home, 90 km from the speech language pathologist. A PC-based videoconferencing system was used, operating at 128 kbit/s over the public telecommunications network. The patient achieved substantial improvements in vocal sound pressure levels during sustained vowel phonation (6.13 dB), reading (12.28 dB) and conversational monologue (11.32 dB). There were improvements in the duration of sustained vowel phonation (4 s). Improvements were also perceived in the degree of breathiness and roughness in the voice, and in overall speech intelligibility in conversation. The patient was very satisfied with the audio and video quality of the conferencing, and with the online treatment overall. He reported a preference for online sessions for the future management of his condition, rather than face-to-face treatment. Remote LSVT delivery was found to be feasible and effective.
Randomized controlled trial of a multisite speech pathology telepractice service providing swallowing and communication intervention to patients with head and neck cancer: Evaluation of service outcomes. [2022]The purpose of this study was to present our evaluation of a new speech pathology telepractice service supporting the swallowing and communication management of patients with head and neck cancer.
Voice Therapy Outcome-A Randomized Clinical Trial Comparing Individual Voice Therapy, Therapy in Group, and Controls Without Therapy. [2021]A stumbling-block in voice therapy is how the patient will be able to apply the new voice technique in everyday life. Possibly this generalization process could be facilitated by giving voice therapy in group because of the natural forum for training voice-to-speech early in communication between the patients in a group setting. The aim of the study was to compare treatment results from individual voice therapy and voice therapy in group, at several time points and in comparison to patients with no voice therapy.