An interventional study of Psychosocial Support for Caregiver and Psychosocial Support for Caregiver in Caregiver, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-15.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
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.
ARM III (CONTROL): 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 an emotionally neutral topic.
After completion of study, participants are followed up at day 17.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Psychosocial Support for Caregiver · Other: Questionnaire Administration
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.
Other: Psychosocial Support for Caregiver · Other: Questionnaire Administration
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 an emotionally neutral topic.
Other: Questionnaire Administration · Other: Sham Intervention
Complete expressive disclosure writing
Complete benefit finding writing
Ancillary studies
Complete writing on an emotionally neutral topic
Change in comforting sensitivity (i.e. quality of social support), measured through writing exercise and anonymous online survey
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.
Time frame: Baseline to day 17
Change in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
Compared between women and men in both treatment groups using paired samples t-test.
Time frame: Baseline to day 17
Change in degree of stress pre- to post-test in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey
Will be analyzed using multiple linear regression.
Time frame: Up to day 17
Change in emotion regulation over time, measured through writing exercise and anonymous online survey
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.
Time frame: Baseline to day 17
Change in stress, measured through writing exercise and anonymous online survey
Will be compared between women and men in both treatment groups using paired samples t-test.
Time frame: Baseline to day 17
Change in stress, perceived burden, and emotion regulation over time, measured through writing exercise and anonymous online survey
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.
Time frame: Baseline to day 17
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
Will be analyzed using multiple linear regression.
Time frame: Baseline to day 17
Changes in emotion regulation in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey
Will be analyzed using multiple linear regression.
Time frame: Up to day 17
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
Analyzed using linear multiple regression.
Time frame: Up to day 17
Post-test emotion regulation scores, measured through writing exercise and anonymous online survey
Compared between traumatic disclosure and benefit finding groups using post-hoc analyses of repeated measures ANOVA.
Time frame: Up to day 17
Use of emotion-related words in predicting differences in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
Will be analyzed using multiple linear regression.
Time frame: Up to day 17
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of Washington