Clinical trial NCT03832686: Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Official title: Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-06
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
timeFrame: 7 weeks
Secondary outcomes:
measure: Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)
timeFrame: 19 weeks
measure: Diet Level as Defined by the Functional Oral Intake Scale (FOIS)
timeFrame: 19 weeks
measure: Diet Restrictions as Measured by the Performance Status Scale Head and Neck
timeFrame: 7 weeks
measure: Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
timeFrame: 19 weeks
measure: Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)
timeFrame: 19 weeks
measure: Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Stanford Universiy
name: Heather Starmer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.