Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Acceptability as assessed by adherence to practice instructions
研究概览
简要总结
This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to other parts of the body, and their caregivers. Web-based mindfulness meditation, which uses audio exercises and interactive webinars taught by trained meditation instructors, may help participants with GI cancer and their caregivers reduce distress and improve their quality of life.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers.
SECONDARY OBJECTIVES:
I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers.
OUTLINE:
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
- 是
入选标准
- •ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
- •ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
- •ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- •ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
- •ELIGIBLE PATIENTS: Be able to speak and read English
- •ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- •ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
- •ELIGIBLE PATIENTS: Be able to provide informed consent
- •ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
- •ELIGIBLE CAREGIVERS: Be able to speak and read English
- •ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- •ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
- •ELIGIBLE CAREGIVERS: Be able to provide informed consent
排除标准
- •Have a current meditation practice (> 2 episodes or > 1 hour total, weekly)
- •Be currently enrolled in a stress reduction program
- •Have extensive hearing loss such that ability to participate in the study would be impaired
- •Have participated in the original Being Present pilot study (BP1)
- •Be caregivers of patients who decline Being Present 2.0 (BP2) study participation
研究组 & 干预措施
Supportive Care (web-based mindfulness meditation)
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
干预措施: Online Mindfulness Meditation (Behavioral)
Supportive Care (web-based mindfulness meditation)
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Acceptability as assessed by adherence to practice instructions
时间窗: At 8 weeks after study start (Up to 1 year)
Number of times participant practices during study, documented via website data capture
Feasibility as assessed by evaluating recruitment rate
时间窗: At end of enrollment (Up to 1 year)
Number of participants approached who consent to participate
Feasibility as assessed by rate of attrition
时间窗: At 8 weeks post end of enrollment (Up to 1 year)
Number of participants dropping out after start of intervention for any reason.
Feasibility as assessed by evaluating rate of refusal to participate
时间窗: At end of enrollment (Up to 1 year)
Number of participants refusing to consent.
次要结局
- Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer(At baseline, week 4 and week 8 after study start (Up to 1 year))
- Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe(At baseline, week 4 and week 8 after study start (Up to 1 year))
- Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)(At baseline, week 4 and week 8 after study start (Up to 1 year))
- Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)(At baseline, week 4 and week 8 after study start (Up to 1 year))