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

NCT02339870 | Completed

• 3 other identifiers: 9216NCI-2014-02511P30CA015704
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (3)

Arm I (expressive disclosure)

EXPERIMENTAL

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: Psychosocial Support for Caregiver; Other: Questionnaire Administration

Arm II (benefit finding)

EXPERIMENTAL

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: Psychosocial Support for Caregiver; Other: Questionnaire Administration

Arm III (control)

SHAM COMPARATOR

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; Other: Sham Intervention

Interventions

Psychosocial Support for Caregiver OTHER

Complete expressive disclosure writing

Arm I (expressive disclosure)

Questionnaire Administration OTHER

Ancillary studies

Arm I (expressive disclosure); Arm II (benefit finding); Arm III (control)

Sham Intervention OTHER

Complete writing on an emotionally neutral topic

Arm III (control)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• If participants are unable to access a computer they will be excluded

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• 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.

  PMID: 33190518 DERIVED

• 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.

  PMID: 28467137 DERIVED

MeSH Terms

Interventions

Psychiatric Rehabilitation; Caregivers

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Health Personnel

Study Officials

• Linda Ko

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 16, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 15, 2016

Record last verified: 2016-02

Locations

US (1)