Status:
COMPLETED
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 und...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03832686
Start Date
April 22 2019
End Date
April 6 2023
Last Update
April 10 2024
Active Locations (3)
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1
Stanford Cancer Institute
Palo Alto, California, United States, 94304
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02114
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111