Expressive Writing in Improving the Wellbeing or Comforting Capacity of Caregivers of Patients With Cancer

Caregiver Clinical Trial

Official title:

Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339870
• Other study ID #: 9216
• Secondary ID: NCI-2014-0251192
• Status: Completed
• Phase: N/A
• First received: December 30, 2014
• Last updated: February 11, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Caregiver

Intervention

Other:
• Psychosocial Support for Caregiver
Complete expressive disclosure writing
• Psychosocial Support for Caregiver
Complete benefit finding writing
• Questionnaire Administration
Ancillary studies
• Sham Intervention
Complete writing on an emotionally neutral topic

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to day 17	No
Primary	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.	Baseline to day 17	No
Primary	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.	Up to day 17	No
Primary	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.	Baseline to day 17	No
Primary	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.	Baseline to day 17	No
Primary	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.	Baseline to day 17	No
Primary	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.	Baseline to day 17	No
Primary	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.	Up to day 17	No
Primary	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.	Up to day 17	No
Primary	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.	Up to day 17	No
Primary	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.	Up to day 17	No