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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Support for Caregiver | Other | Complete expressive disclosure writing |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Ko | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33190518 | Derived | 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. | |
| 28467137 | 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. |
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| Psychosocial Support for Caregiver | Other | Complete benefit finding writing |
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| Questionnaire Administration | Other | Ancillary studies |
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| Sham Intervention | Other | Complete writing on an emotionally neutral topic |
|
| 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 |
| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D006282 | Health Personnel |
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