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

Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity

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.

Study Overview

• Status: Completed
• Conditions: Caregiver
• Intervention / Treatment: Other: Questionnaire Administration; Other: Psychosocial Support for Caregiver; Other: Psychosocial Support for Caregiver; Other: Sham Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Psychosocial Support for Caregiver; Complete expressive disclosure writing; Other: Psychosocial Support for Caregiver; Complete benefit finding writing
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Psychosocial Support for Caregiver; Complete expressive disclosure writing; Other: Psychosocial Support for Caregiver; Complete benefit finding writing
Sham Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Sham Intervention; Complete writing on an emotionally neutral topic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Linda Ko, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• Harvey J, Berndt M. Cancer caregiver reports of post-traumatic growth following spousal hematopoietic stem cell transplant. Anxiety Stress Coping. 2021 Jul;34(4):397-410. doi: 10.1080/10615806.2020.1845432. Epub 2020 Nov 15.
• Harvey J, Sanders E, Ko L, Manusov V, Yi J. The Impact of Written Emotional Disclosure on Cancer Caregivers' Perceptions of Burden, Stress, and Depression: A Randomized Controlled Trial. Health Commun. 2018 Jul;33(7):824-832. doi: 10.1080/10410236.2017.1315677. Epub 2017 May 3.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 9216 (Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2014-02511 (Registry Identifier: CTRP (Clinical Trial Reporting Program))