Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post-test emotion regulation scores, measured through writing exercise and anonymous online survey
研究概览
简要总结
This randomized clinical trial studies expressive writing in improving the wellbeing or comforting capacity of caregivers of patients with cancer. Expressive writing is a type of intervention that asks people to write about important topics (in this case participants' experience with their spouses'/partners' cancer) and their emotions/feelings surrounding them. Expressive writing, including benefit finding and traumatic disclosure, may be a type of at-home-therapy that caregivers can utilize in an attempt to increase their own wellbeing, offer better comfort to cancer patients, and by association, help cancer patients cope with and manage the cancer experience.
详细描述
PRIMARY OBJECTIVES:
I. To test whether one, or both, types of expressive writing impact spouses of cancer survivors' reported emotional wellbeing and reported ability to provide comfort as compared to a control group.
OUTLINE: Patients are randomized to 1 of 2 arms or assigned to a control arm.
ARM I (EXPRESSIVE DISCLOSURE): Participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks (days 2, 9, and 16 for a total of 3 sessions). Participants write about their emotions pertaining to managing and providing care for the cancer patient.
ARM II (BENEFIT FINDING): Participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks (days 2, 9, and 16 for a total of 3 sessions). Participants write about any benefits that have arisen because of the cancer diagnosis.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be a spouse or domestic partner of a cancer survivor and will be recruited via the Hematopoietic Stem Cell Transplant Database at Fred Hutchinson Cancer Research Center (FHCRC)
- •Participants must have been in their spousal relationship for at least the past 1 year
排除标准
- •If participants are unable to access a computer they will be excluded
结局指标
主要结局
Post-test emotion regulation scores, measured through writing exercise and anonymous online survey
时间窗: Up to day 17
Compared between traumatic disclosure and benefit finding groups using post-hoc analyses of repeated measures ANOVA.
Change in degree of stress pre- to post-test in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey
时间窗: Up to day 17
Will be analyzed using multiple linear regression.
Change in emotion regulation over time, measured through writing exercise and anonymous online survey
时间窗: Baseline to day 17
Will be compared between traumatic disclosure participants and the control group and between benefit finding participants and the control group using repeated measures ANOVA within/between interaction.
Change in use of cognitive mechanism words in expressive writing in predicting significantly higher increases in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
时间窗: Baseline to day 17
Will be analyzed using multiple linear regression.
Change in comforting sensitivity (i.e. quality of social support), measured through writing exercise and anonymous online survey
时间窗: Baseline to day 17
Will be reported pre- to post-test for both treatment groups compared to the control group. Repeated measures analysis of variance (ANOVA) within/between interaction will be used.
Change in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
时间窗: Baseline to day 17
Compared between women and men in both treatment groups using paired samples t-test.
Change in stress, measured through writing exercise and anonymous online survey
时间窗: Baseline to day 17
Will be compared between women and men in both treatment groups using paired samples t-test.
Change in stress, perceived burden, and emotion regulation over time, measured through writing exercise and anonymous online survey
时间窗: Baseline to day 17
Will be compared between traumatic disclosure participants and the control group and between benefit finding participants and the control group using repeated measures ANOVA within/between group interaction.
Changes in emotion regulation in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey
时间窗: Up to day 17
Will be analyzed using multiple linear regression.
Degree of stress, perceived burden, and emotion regulation in predicting comforting sensitivity (i.e. social support quality), measured through writing exercise and anonymous online survey
时间窗: Up to day 17
Analyzed using linear multiple regression.
Use of emotion-related words in predicting differences in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
时间窗: Up to day 17
Will be analyzed using multiple linear regression.
次要结局
未报告次要终点