Feasibility Study of a Nurse-Delivered Telephone Intervention To Impact Mucositis Symptom Severity and Prevent Dehydration in Lung and Head/Neck Cancer Patients Undergoing Chemoradiation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of participants that completed calls
研究概览
简要总结
This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Non-Small Cell or Limited Stage Small Cell Lung Cancer OR Head & Neck Cancer
- •Over 18 years old
- •Eligible for concurrent Chemoradiation in the first line setting
- •Eastern Cooperative Group 0-2 (able to complete Activity of Daily Living (ADLs) independently or with assistive device only)
- •Able to read & write English or Spanish
排除标准
- •Under 18 years old
- •Underlying Anxiety or Depression (must pass screening tools)
- •Medically Diagnosed with a Cognitive Impairment
- •No prior Chemotherapy or Radiation treatment
- •No access to a telephone
- •Blind or Deaf or Illiterate
- •Requires assistance with Self-Care ADLs
结局指标
主要结局
Number of participants that completed calls
时间窗: 6 weeks
Defined as the number of participants that completed 80% of the total 12 calls.
Percentage of patients using Intervention materials
时间窗: 6 weeks
Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).
Duration of phone call
时间窗: 6 weeks
Amount of time of the patient daily phone call (in minutes).
次要结局
- Attrition Rate(6 weeks)
- Study Completion Rate(6 weeks)
- Participant Satisfaction(6 weeks)
- Unscheduled Medical Visits(6 weeks)
- Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy(10 weeks)
- Change in severity of mucositis(6 weeks)
- Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management(10 weeks)
- Change in overall symptom severity(10 weeks)
- Change in quality of life(10 weeks)
研究者
Raphael Yechieli
Associate Professor of Clinical Medicine
University of Miami