A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in self-reported stress levels assessed using pre- and post-test assessments
研究概览
简要总结
This randomized pilot trial studies mindfulness-based program in educating patients with colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce stress and fatigue in patients with colorectal cancer and their caregivers.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the effect of a brief educational program on colorectal cancer knowledge acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing visual/written educational material with and without mindfulness training to the standard of care.
II. To determine the priming effect of a brief mindfulness training on retaining knowledge of colorectal cancer education.
III. To determine the joint effect of colorectal cancer education delivered to both the patient and a caregiver on the overall colorectal cancer knowledge.
SECONDARY OBJECTIVES:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with colorectal cancer
- •Patients with at least one more chemotherapy appointment at the time of enrollment
- •if patients have a caregiver, patients should agree to bring a caregiver to one of their hospital visits or have the caregiver schedule a separate study visit
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Illiterate participants
- •Deaf participants
- •Participants that do not read speak or understand either Spanish or English
研究组 & 干预措施
Group I (standard of care)
Patients and caregivers receive standard of care.
Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
干预措施: educational intervention (Other)
Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
干预措施: caregiver-related intervention or procedure (Other)
Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
干预措施: questionnaire administration (Other)
Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
干预措施: laboratory biomarker analysis (Other)
Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
干预措施: educational intervention (Other)
Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
干预措施: CAM exercise therapy (Procedure)
Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
干预措施: caregiver-related intervention or procedure (Other)
Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
干预措施: questionnaire administration (Other)
Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Change in self-reported stress levels assessed using pre- and post-test assessments
时间窗: Baseline to up to 60 minutes
The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way analyses of variance (ANOVAs).
Change in colorectal cancer knowledge assessed using pre- and post-test assessments
时间窗: Baseline to up to 60 minutes
The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way ANOVAs.
次要结局
- Changes in salivary cortisol levels using chemiluminescence immunoassay(Baseline to up 60 minutes)