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Trial record 2 of 2168 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

Tracking Information
First Submitted Date  ICMJE December 30, 2014
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2015)
  • Change in comforting sensitivity (i.e. quality of social support), measured through writing exercise and anonymous online survey [ Time Frame: Baseline to day 23 ]
    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.
  • Change in stress, perceived burden, and emotion regulation over time, measured through writing exercise and anonymous online survey [ Time Frame: Baseline to day 23 ]
    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.
  • 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 23 ]
    Analyzed using linear multiple regression.
  • Change in emotion regulation over time, measured through writing exercise and anonymous online survey [ Time Frame: Baseline to day 23 ]
    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.
  • Post-test emotion regulation scores, measured through writing exercise and anonymous online survey [ Time Frame: Up to day 23 ]
    Compared between traumatic disclosure and benefit finding groups using post-hoc analyses of repeated measures ANOVA.
  • Change in stress, measured through writing exercise and anonymous online survey [ Time Frame: Baseline to day 23 ]
    Will be compared between women and men in both treatment groups using paired samples t-test.
  • Change in comforting sensitivity (support quality), measured through writing exercise and anonymous online survey [ Time Frame: Baseline to day 23 ]
    Compared between women and men in both treatment groups using paired samples t-test.
  • 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 23 ]
    Will be analyzed using multiple linear regression.
  • 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 23 ]
    Will be analyzed using multiple linear regression.
  • Changes in emotion regulation in predicting an increase in comforting strategies, measured through writing exercise and anonymous online survey [ Time Frame: Up to day 23 ]
    Will be analyzed using multiple linear regression.
  • 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 23 ]
    Will be analyzed using multiple linear regression.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Expressive Writing in Improving the Wellbeing or Comforting Capacity of Caregivers of Patients With Cancer
Official Title  ICMJE Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Caregiver
Intervention  ICMJE
  • Other: Psychosocial Support for Caregiver
    Complete expressive disclosure writing
  • Other: Psychosocial Support for Caregiver
    Complete benefit finding writing
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Sham Intervention
    Complete writing on an emotionally neutral topic
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Psychosocial Support for Caregiver
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Psychosocial Support for Caregiver
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Questionnaire Administration
    • Other: Sham Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 12, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02339870
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Washington
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Washington
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Linda Ko Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP