A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ)-8
研究概览
简要总结
This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To assess if a 12-week virtual weight management program with a mindfulness component will improve well-being of obese cancer patients with a specific focus on self-reported measures of depression and anxiety.
II. To assess if a mindfulness component added to the virtual behavioral weight management will promote weight loss, improve mood, and increase physical activity.
OUTLINE:
Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •18 or over
- •Identified stage I, II, or III cancer in remission
- •Body mass index (BMI) of 30 or greater
- •English as a primary language
- •Has access to a device with a camera (computer, tablet, or video capable phone) that has wifi and reliable internet access
排除标准
- •Unable to provide consent
- •Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above
结局指标
主要结局
Patient Health Questionnaire (PHQ)-8
时间窗: Baseline; 12 weeks
Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression).
General anxiety disorder-7 (GAD-7)
时间窗: Baseline; 12 weeks
Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety).
Feasibility of virtual mindfulness and weight management program
时间窗: 12 weeks
Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12.
次要结局
- Body weight(Baseline; 12 weeks)
- Body composition parameter(Baseline; 12 weeks)
- Daily activity levels - heart rate(Baseline; 12 weeks)
- Daily activity levels - activity(Baseline; 12 weeks)