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Trial record 2 of 2131 for:    benefit finding

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339870
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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.

Condition or disease Intervention/treatment Phase
Caregiver Other: Psychosocial Support for Caregiver Other: Questionnaire Administration Other: Sham Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
Study Start Date : April 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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: Psychosocial Support for Caregiver
Complete expressive disclosure writing

Other: Questionnaire Administration
Ancillary studies

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: Psychosocial Support for Caregiver
Complete benefit finding writing

Other: Questionnaire Administration
Ancillary studies

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339870


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Linda Ko Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02339870    
Other Study ID Numbers: 9216
NCI-2014-02511 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9216 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016