Virtual Group Speech Therapy for Head and Neck Cancer

Overseen By Houda Bahig, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Metastases, Laryngectomy, Dysphagia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

76 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 6 7 8 9}

How 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. ^{10 11 12 13 14}

Eligibility 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.

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.

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

Treatment Details

Interventions

• Virtual Group Speech Pathology Intervention

Trial Overview 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.

Participant Groups

Group I: virtual group speech therapy intervention guided by a patient partner Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Université du Québec à Trois-Rivières

Collaborator

Trials

48

Recruited

4,500+

Findings from Research

This study analyzed functional outcomes in 293 head and neck cancer patients treated in Victoria, Australia, providing valuable data on speech, swallowing, and quality of life after treatment.

The findings suggest that optimal recovery of function typically occurs around six months post-treatment, establishing a reference point for future comparisons in similar patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Perry, AR., Shaw, MA., Cotton, S.[2006]

The study involved 67 head and neck cancer patients and found that many experienced speech and swallowing problems, which significantly impacted their quality of life and emotional well-being.

Using the OncoQuest computerized monitoring system in an outpatient clinic proved feasible for tracking these issues, highlighting the importance of ongoing assessment in managing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized monitoring of patient-reported speech and swallowing problems in head and neck cancer patients in clinical practice. Cnossen, IC., de Bree, R., Rinkel, RN., et al.[2021]

In a 3-month pilot clinic involving 218 patients with head and neck cancer, Speech and Language Therapists (SLTs) effectively conducted assessments and treatment planning, demonstrating a safe collaboration with otolaryngologists.

The clinic identified a low cancer diagnostic yield of 5%, but found that higher scores on voice assessments (GRBAS) and patient-reported outcomes (VHI-10) were associated with a greater risk of serious diagnoses, suggesting these measures could help in identifying patients needing further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Butler, J., Sellstrom, D., Eastwood, N., et al.[2023]

A prospective database has been established in Melbourne, Australia, to track functional outcomes related to speech, swallowing, and voice in head and neck cancer patients, involving collaboration from eight hospitals and ongoing data collection since April 1997.

The early results from this database, after 12 months of data collection, highlight its potential for clinically-based research and benchmarking outcomes, although challenges in long-term data accuracy for this patient population are acknowledged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Perry, AR., Shaw, MA.[2019]

A study involving 11 speech pathology staff from two regional/remote services identified 30 actionable goals to improve speech pathology services for head and neck cancer patients, focusing on enhancing access and delivery in rural areas.

The most critical area for change highlighted was the need for increased support in training, mentoring, and supervision, which is essential for consolidating skills among speech pathology professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech pathology service enhancement for people with head and neck cancer living in rural areas: Using a concept mapping approach to inform service change. Foley, J., Ward, EC., Burns, CL., et al.[2021]

A study of 128 non-laryngeal head and neck cancer survivors revealed that voice impairment is a common issue after treatment with radiotherapy (RT) or chemoradiotherapy (CRT), with significant findings of muscle tension and strain in the vocal cords.

The research highlighted that vocal handicap index (VHI) scores were significantly associated with dysphonia and treatment type, suggesting that targeted voice treatment regimens are needed to improve the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle Tension Dysphonia: A Sequeale of Chemoradiotherapy in Patients of Head and Neck Cancer. Sarin, V., Sarin, BC., Chatterjee, A., et al.[2023]

The shift to synchronous online clinical services for speech-language pathologists (SLPs) during the COVID-19 pandemic may lead to changes in vocal behaviors that could negatively affect voice production.

To prevent phonogenic voice problems, SLPs are encouraged to adopt new strategies for maintaining vocal health while delivering services online, guided by injury prevention frameworks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phonogenic Voice Problems among Speech-Language Pathologists in Synchronous Telepractice: An Overview and Recommendations. Knickerbocker, K., Bryan, C., Ziegler, A.[2021]

In a study of 150 head and neck cancer patients over 12 months, better speech articulation was linked to a lower risk of dropout from the study, indicating that speech outcomes are crucial for patient retention.

Swallowing function did not show a significant relationship with dropout rates, suggesting that speech outcomes may be more critical in understanding patient experiences and the impact of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relating speech and swallow function to dropout in a longitudinal study of head and neck cancer. Colangelo, LA., Logemann, JA., Rademaker, AW., et al.[2007]

The Electronic Patient Visit Assessment (ePVA) is a reliable and valid web-based tool that effectively captures patient-reported symptoms and functional limitations in individuals with head and neck cancer, demonstrating a high completion rate (92%) among participants.

The ePVA correlates significantly with health-related quality of life (HRQoL) scores, indicating that patients with more symptoms and limitations experience worse HRQoL, thus supporting its potential for real-time clinical interventions to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer. Van Cleave, JH., Fu, MR., Bennett, AV., et al.[2022]

A study involving 187 patients showed that both individual and group voice therapy significantly improved self-perceived voice function over a year, with moderate to large effect sizes based on the Swedish Voice Handicap Index (VHI-11).

The most common reason for patients not attending recommended voice therapy was lack of time, highlighting a potential barrier to accessing these effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Voice Therapy: A Comparison Between Individual and Group Therapy. Abrahamsson, M., Millgård, M., Havstam, C., et al.[2018]

Telepractice models, including asynchronous applications and videoconferencing, can significantly improve access to speech language pathology (SLP) services for patients with head and neck cancer, enhancing management of swallowing and communication disorders.

Patient and clinician satisfaction with these telepractice models is high, indicating their potential effectiveness, but further research is needed to evaluate large-scale implementation and economic impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of telepractice for head and neck cancer management: a review of speech language pathology service models. Ward, EC., Wall, LR., Burns, CL., et al.[2018]

The online delivery of the Lee Silverman Voice Treatment (LSVT) for a patient with Parkinson's disease resulted in significant improvements in vocal sound pressure levels and speech intelligibility, demonstrating its efficacy.

The patient expressed high satisfaction with the online treatment format and preferred it over traditional face-to-face sessions, indicating that remote delivery of LSVT is both feasible and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based speech treatment for Parkinson's disease delivered remotely: a case report. Constantinescu, GA., Theodoros, DG., Russell, TG., et al.[2022]

The study evaluated a new telepractice service for speech pathology in managing swallowing and communication for head and neck cancer patients, involving 82 referrals across three sites.

Results showed that the telepractice model significantly improved service efficiency, reducing both the number and duration of contact events, while also increasing satisfaction for both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Burns, CL., Ward, EC., Hill, AJ., et al.[2022]

A study involving 77 patients with functional voice disorders found that both individual and group voice therapy led to significant long-term improvements in voice quality and reduced voice-related handicap, as measured by the Voice Handicap Index (VHI) and other assessments.

Group therapy showed greater benefits over individual therapy, particularly in the physical aspects of voice handicap, suggesting that the group setting may enhance the application of voice techniques in everyday communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Therapy Outcome-A Randomized Clinical Trial Comparing Individual Voice Therapy, Therapy in Group, and Controls Without Therapy. Ohlsson, AC., Dotevall, H., Gustavsson, I., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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]

2. Germany pubmed.ncbi.nlm.nih.gov

Computerized monitoring of patient-reported speech and swallowing problems in head and neck cancer patients in clinical practice. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. India pubmed.ncbi.nlm.nih.gov

Muscle Tension Dysphonia: A Sequeale of Chemoradiotherapy in Patients of Head and Neck Cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Phonogenic Voice Problems among Speech-Language Pathologists in Synchronous Telepractice: An Overview and Recommendations. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Relating speech and swallow function to dropout in a longitudinal study of head and neck cancer. [2007]

9. China pubmed.ncbi.nlm.nih.gov

The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Voice Therapy: A Comparison Between Individual and Group Therapy. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Application of telepractice for head and neck cancer management: a review of speech language pathology service models. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Home-based speech treatment for Parkinson's disease delivered remotely: a case report. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

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]

14. United States pubmed.ncbi.nlm.nih.gov

Voice Therapy Outcome-A Randomized Clinical Trial Comparing Individual Voice Therapy, Therapy in Group, and Controls Without Therapy. [2021]