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Clinical Trials/NCT02339870
NCT02339870
Completed
Not Applicable

Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity

University of Washington1 site in 1 country100 target enrollmentApril 2015
ConditionsCaregiver

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver
Sponsor
University of Washington
Enrollment
100
Locations
1
Primary Endpoint
Post-test emotion regulation scores, measured through writing exercise and anonymous online survey
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • If participants are unable to access a computer they will be excluded

Outcomes

Primary Outcomes

Post-test emotion regulation scores, measured through writing exercise and anonymous online survey

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Up to day 17

Will be analyzed using multiple linear regression.

Study Sites (1)

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