NCT06008574进行中（未招募）不适用
Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 14
- 主要终点
- Adherence Retention rate
研究概览
简要总结
The purpose of this study is to find out if it is practical to provide the program contained within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform that re-configures according to the specific needs of patients through physician prescriptions.
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
- 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
- •Histologically proven lung cancer
- •Patients with suspected primary lung cancer per recent chest CT scan (with or without contrast) may be enrolled in the trial. These patients may be randomized and begin study intervention without a biopsy. If a patient undergoes a biopsy after consent and the results are negative or if the patient does not proceed with surgery, the patient will be removed from the study. The patient will continue to receive full access to the AmDTx app for 2-years.
- •Scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice [intervention group] 14 days preoperatively)
- •Age ≥18 years of age at time of signing informed consent
- •Access to a smartphone/tablet with data connection
- •Willing to give time for mindfulness practice (Patients need to have the motivation to devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over the course of a minimum of 6 weeks to do the mindfulness meditations and practices)
- •Willing to be randomized to mindfulness MBCR or CI group and complete all assessments
- •High distress level (Distress Thermometer score ≥4 at initial visit)
- •Able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent
- •Able to read, speak, and understand English
排除标准
- •Currently engaging in app-based mindfulness or meditation for one or more times per week
- •As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility before consent
- •Individuals with impaired decision-making capacity
- •Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation)
- •Patients undergoing active treatment of other non-lung cancers
- •Patients with recurrent lung cancer
结局指标
主要结局
Adherence Retention rate
时间窗: up to 3 months
Retention rates will be calculated separately as the proportion of enrolled participants who complete the 4-week and 3-month follow-up surveys. Adherence: The AmDTx app automatically collects adherence data, including date, time, length, and name of session to which participants listened, and transfers the data to the researchers on a weekly basis.
次要结局
- Decrease in anxiety symptoms(up to 6 months)
研究者
研究点 (14)
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