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

NCT03832686 | Completed Results

• 3 other identifiers: IRB-48015ENT0070NCI-2019-04958
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Head Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)

  19 weeks

• Diet Level as Defined by the Functional Oral Intake Scale (FOIS)

  19 weeks

• Diet Restrictions as Measured by the Performance Status Scale Head and Neck

  7 weeks

• Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)

  19 weeks

• Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)

  19 weeks

Study Arms (2)

Virtual Coach App

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Virtual Coach OTHER

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.

Virtual Coach App

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• 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.

  PMID: 35960394 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Heather Starmer, MD
• Organization: Stanford University

hstarmer@stanford.edu

650-529-5903

Study Officials

• Heather Starmer

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor and Director of the Head and Neck Cancer Speech and Swallowing Rehabilitation Center

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 6, 2019
• Study Start: April 22, 2019
• Primary Completion: March 3, 2022
• Study Completion: April 6, 2023
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)