Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Individuals with contraindications to radiation therapy.
结局指标
主要结局
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
时间窗: 7 weeks
Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week.
次要结局
- Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)(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)
- Diet Level as Defined by the Functional Oral Intake Scale (FOIS)(19 weeks)
- Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)(19 weeks)
- Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale(7 weeks)
研究者
Heather Starmer
Clinical Associate Professor and Director of the Head and Neck Cancer Speech and Swallowing Rehabilitation Center
Stanford University