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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity

Conditions
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Caregiver

Intervention / Treatment
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* Other: Psychosocial Support for Caregiver
* Other: Psychosocial Support for Caregiver
* Other: Questionnaire Administration
* Other: Sham Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (expressive disclosure)<br>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<br>* Complete expressive disclosure writing<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (benefit finding)<br>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<br>* Complete benefit finding writing<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Sham Comparator: Arm III (control)<br>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<br>* Ancillary studies<br>Other: Sham Intervention<br>* Complete writing on an emotionally neutral topic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |