A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Retention rate (Feasibility)
研究概览
简要总结
This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.
详细描述
PRIMARY OBJECTIVE:
I. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care prior to their scheduled screening colonoscopy.
GROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be ages 45-75
- •Patients must be at average risk for colorectal cancer (CRC)
- •Patients must have scheduled their first-time screening colonoscopy as an outpatient at Ohio State University (OSU) at least 14 days in advance
- •Patients must be able to speak and read English
- •Patients must have daily access to a working telephone, email address, and internet connection
- •Patients must provide consent
排除标准
- •Previous colonoscopy
- •Colonoscopy for diagnostic purposes
- •Auditory or visual impairment that prevents internet use
- •Previous cancer diagnosis (other than skin cancer)
- •Previous diagnosis of a mental health disorder
- •Current mental health treatment
- •Family history of CRC
- •Personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •Confirmed or suspected hereditary CRC syndrome, such as familial adenomatous polyposis or Lynch syndrome
结局指标
主要结局
Retention rate (Feasibility)
时间窗: Up to 4 weeks
Feasibility will be assessed by the number of patients referred, number of participants recruited, and missing data from surveys and medical records. Feasibility will be achieved with a retention rate of 90% throughout the intervention. An independent samples t-test will be conducted to compare State-Trait Anxiety Inventory: State-Subscale (STAI-S) scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.
Satisfaction with the intervention (Acceptability)
时间窗: At follow-up (1-2 days after the colonoscopy)
Acceptability will be assessed by the number of intervention materials accessed and time to complete study activities (infographics, meditations, and surveys) via embedded REDCap metrics. Participants within the MBI group will also report meditation satisfaction and state mindfulness immediately after each meditation in addition to intervention satisfaction during the follow-up survey. Will report an average satisfaction score with the intervention \>= 6.0, measured using a 7-point Likert scale. An independent samples t-test will be conducted to compare STAI-S scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.
次要结局
- Colonoscopy nervousness(At pre-colonoscopy assessment)
- Mindfulness(At follow-up (1-2 days after the colonoscopy))
- Mindfulness knowledge(At follow up (1-2 days after the colonoscopy))
- Attitudes about CRC and CRC screening(At follow up (1-2 days after the colonoscopy))
- Colorectal screening knowledge(At follow up (1-2 days after the colonoscopy))
- Sedative dose(Up to 4 weeks)
- Bowel prep adherence(At pre-colonoscopy assessment)
- Cancellation/no-show(At pre-colonoscopy assessment)
- Bowel prep quality(Up to 4 weeks)
- Endoscopy suite time(Up to 4 weeks)
- Bowel prep difficulty(At pre-colonoscopy assessment)
- Heart rate(Up to 4 weeks)
- Cecal intubation time(At post-colonoscopy)
- Blood pressure(Up to 4 weeks)
- Procedural time(Up to 4 weeks)
- Intent for future CRC screening(At follow up (1-2 days after the colonoscopy))
- Procedure satisfaction(At follow up (1-2 days after the colonoscopy))
研究者
Mira Katz
Principal Investigator
Ohio State University Comprehensive Cancer Center