NCT02063828终止不适用
Reducing Lung Cancer-Related Anxiety (RELAX)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 22
- 主要终点
- Accrual Rate- Number of Patients Accrued to the Study
研究概览
简要总结
The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.
详细描述
OBJECTIVES
- To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety.
- To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors.
- To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Past History of any lung cancer
- •For Stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease.
- •For Stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease.
- •After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible.
- •Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
- •Age ≥ 18 years
- •Must have telephone
排除标准
- •Patient does not understand English
- •Active lung infection
- •Progressive cancer (must be considered no evidence of disease or stable)
- •Any change in psychotropic medications in past 30 days
- •Hearing loss that would preclude participating in interventions. Adequate hearing to participate will be determined via: (1) Response of "no" to the question ["Do you have a hearing problem now?"] Participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. If necessary, potential study participants will receive a brief test trial with the RESPeRATE device. If they indicate inability to hear the guiding tones, they will not be enrolled in the study.
- •Cortisol Exclusion
- •Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted).
结局指标
主要结局
Accrual Rate- Number of Patients Accrued to the Study
时间窗: Time from study opening to study close ~46.42 months
The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.
Retention - Number of Participants Who Complete the Final Assessment
时间窗: 12 weeks
Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Adherence- Amount of Time the Device is Used
时间窗: 12 weeks
Adherence will be calculated as the actual amount of time the device is used divided by the prescribed time. Successful adherence will be defined as use of the device ≥80% of the time assigned.
次要结局
- Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)(12 weeks)
研究者
研究点 (22)
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