NCT03832686

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has recently seen a dramatic rise in the United States due to a rise in the incidence of oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients diagnosed with HNC receive radiation therapy at some point in their treatment, either in the definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC, experienced by approximately 50% of patients treated with radiation therapy. Post-treatment dysphagia has been associated with increased risk of morbidity/mortality as well as well-recognized deterioration of quality of life. Performance of swallowing exercises during radiation significantly reduces dysphagia risk; however, patient adherence to swallowing exercises during radiation treatment is limited. Thus, poor adherence stands as a major obstacle to achieving the best swallowing outcomes. In response to this, a mobile health application was developed to directly address barriers cited by patients as reasons for non-adherence. The objective is to conduct a randomized controlled trial to test the impact of the mobile application on adherence to prophylactic swallowing therapy during radiation for HNC.

Conditions

• Head Neck Cancer

Interventions

Type	Name	Description
OTHER	Virtual Coach	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.

Timeline

• Start date: 2019-04-22
• Primary completion: 2022-03-03
• Completion: 2023-04-06
• First posted: 2019-02-06
• Last updated: 2024-04-10
• Results posted: 2024-04-10

Locations

3 sites across 1 country: United States