Skip to main content
OpenTrials
Completed

NCT Number: NCT02339870

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caregiver

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial Support for Caregiver

Other

Complete expressive disclosure writing

Questionnaire Administration

Other

Ancillary studies

Sham intervention

Other

Complete writing on an emotionally neutral topic

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2015
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.