Clinical trial NCT02339870: Expressive Writing in Improving the Wellbeing or Comforting Capacity of Caregivers of Patients With Cancer
Official title: Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in comforting sensitivity (i.e. quality of social support), measured through writing exercise and anonymous online survey
timeFrame: Baseline to day 17
measure: Change in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
timeFrame: Baseline to day 17
measure: Change in degree of stress pre- to post-test in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey
timeFrame: Up to day 17
measure: Change in emotion regulation over time, measured through writing exercise and anonymous online survey
timeFrame: Baseline to day 17
measure: Change in stress, measured through writing exercise and anonymous online survey
timeFrame: Baseline to day 17
measure: Change in stress, perceived burden, and emotion regulation over time, measured through writing exercise and anonymous online survey
timeFrame: Baseline to day 17
measure: 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
timeFrame: Baseline to day 17
measure: Changes in emotion regulation in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey
timeFrame: Up to day 17
measure: 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
timeFrame: Up to day 17
measure: Post-test emotion regulation scores, measured through writing exercise and anonymous online survey
timeFrame: Up to day 17
measure: Use of emotion-related words in predicting differences in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey
timeFrame: Up to day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Linda Ko
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.