Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- salivary cortisol levels
研究概览
简要总结
Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors.
详细描述
This study aims to evaluate a computer-based stress-management therapy called expressive writing. This involves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer or to type in your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have completed their cancer radiation treatment (intent to cure),
- •are cancer free, i.e. do not have currently have a diagnosis of primary/secondary cancer or any recurrence/relapse of cancer,
- •are in the re-entry phase of cancer survivorship, i.e. 2-12 months post-treatment completion,
- •have access to a computer and internet in a private setting, e.g. at home,
- •are fluent in English,
- •are able to provide informed consent.
排除标准
- •patients scheduled to undergo any type of cancer treatment (intent to cure/palliative) in the future (e.g. surgery after completing radiation),
- •patients on any kind of corticosteroid medication (e.g. long-term prednisone therapy),
- •patients having any condition that affects function of the adrenal glands (e.g. adrenal hyperplasia),
- •patients with limited ability to produce saliva, e.g. patients that received radiation (or surgery) on the face region or on salivary glands; or patient's suffering from dry mouth (e.g. Sjögren's syndrome),
- •patient's suffering from inflammation of the oral cavity (e.g. gingivitis).
结局指标
主要结局
salivary cortisol levels
时间窗: Up to 6 weeks
Participants will be asked to give their saliva samples through chewable swabs 3 times per day on every day of data collection, i.e. once at baseline, which is 24 hours before the intervention, and twice after the intervention, specifically, 24 hours and 6 weeks post-intervention. Participants will be requested to chew on their swabs and spit into their containers at the following times: 1) immediately after waking up, 2) within 30 min after waking, and 3) immediately before going to sleep.
次要结局
- salivary α-amylase and C-Reactive Protein (CRP)(Up to 6 weeks)
- self-reported psychometric measures(Up to 6 weeks)