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

February 11, 2016 updated by: University of Washington

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
Baseline to day 17
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.
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
Time Frame: Up to day 17
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
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.
Baseline to day 17
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.
Baseline to day 17
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.
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
Time Frame: Baseline to day 17
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
Time Frame: Up to day 17
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
Time Frame: Up to day 17
Analyzed using linear multiple regression.
Up to day 17
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.
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
Time Frame: Up to day 17
Will be analyzed using multiple linear regression.
Up to day 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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