COVID-19: A Virtual Feasibility Study to Manage Stress
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Participant response rate
研究概览
简要总结
This clinical trial evaluates the effect of expressive writing for the management of stress in cancer survivors. Cancer diagnosis and treatment are associated with increased stress in cancer survivors related to concerns about family, career, relationships, finances, side effects of treatment, and death. This stress can be further exacerbated by social upheavals such as the COVID-19 pandemic. For safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. Together with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. Expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience. The goal of this trial is to learn more about the experiences of cancer survivors during stressful times.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of the virtual study for cancer survivors. II. To preliminarily assess the impact of the intervention for cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION): Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) once weekly (QW) for 3 weeks.
ARM II (CONTROL): Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.
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 (Participant, Outcomes Assessor)
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
- •At least 18 years old
- •Have a diagnosis of cancer within the past 3 years
- •Are able to speak and read in English
- •Have access to a computer or smart phone with internet connection
- •All disease sites and all cancer stages are eligible for enrollment
排除标准
- •Inability to provide informed consent
- •Non-English speakers will be excluded because this is a feasibility study that will enroll only a limited number of participants
研究组 & 干预措施
Arm I (questionnaires, messages, writing)
Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) QW for 3 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (questionnaires, messages, writing)
Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.
干预措施: Questionnaire Administration (Other)
Arm I (questionnaires, messages, writing)
Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) QW for 3 weeks.
干预措施: Behavioral Intervention (Behavioral)
Arm I (questionnaires, messages, writing)
Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) QW for 3 weeks.
干预措施: Quality-of-Life Assessment (Other)
Arm II (questionnaires, messages, writing)
Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.
干预措施: Behavioral Intervention (Behavioral)
Arm II (questionnaires, messages, writing)
Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Participant response rate
时间窗: 1 month
Study completion rate
时间窗: 1 month
Intervention adherence rate
时间窗: 1 month
次要结局
- Change in quality of life(Baseline and 1-, 3-, and 6-month follow-up)
- Change in physical health (sleep, fatigue, and cancer related morbidities)(Baseline and 1-, 3-, and 6-month follow-up)
- Change in stress(Baseline and 1-, 3-, and 6-month follow-up)
- Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence)(Baseline and 1-, 3-, and 6-month follow-up)