Clinical trial · Interventional
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
NCT03832686CI-TRIAL-00075899completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head Neck Cancer | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Virtual Coach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Coach App
- description
- 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.
- interventionNames
- Other: Virtual Coach
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- RESULTStarmer 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