CaregiverNCT02339870
Expressive Writing in Improving the Wellbeing or Comforting Capacity of Caregivers of Patients With Cancer
A study testing Psychosocial Support for Caregiver and Questionnaire Administration in people with Caregiver, run by University of Washington at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver
- What is being tested?
- Psychosocial Support for Caregiver and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- If participants are unable to access a computer they will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Caregiver
- Being tested
- Psychosocial Support for Caregiver, Questionnaire Administration, Sham Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Support for CaregiverOther
Complete expressive disclosure writing
Psychosocial Support for CaregiverOther
Complete benefit finding writing
Questionnaire AdministrationOther
Ancillary studies
Sham InterventionOther
Complete writing on an emotionally neutral topic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Questionnaire Administration; Other: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Linda Ko, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339870
- Sponsor's protocol ID
- 9216
- Other IDs
- NCI-2014-02511, 9216, P30CA015704
- Status last verified
- Feb 2016
- First submitted
- 30 Dec 2014
- Last updated
- 15 Feb 2016
- Results posted
- No
Publications
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.
PubMed 33190518Harvey 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.
PubMed 28467137
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Caregivers: Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
- ClinicalTrials.gov ID
- NCT02339870
- Acronym / sponsor ID
- 9216
- Conditions
- Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (expressive disclosure) | Experimental | Other: Psychosocial Support for Caregiver, Other: Questionnaire AdministrationParticipants 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 | Other: Psychosocial Support for Caregiver, Other: Questionnaire AdministrationParticipants 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 | Other: Questionnaire Administration, Other: Sham InterventionParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- If participants are unable to access a computer they will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial Support for CaregiverComplete expressive disclosure writing | Other | Arm I (expressive disclosure) |
| Psychosocial Support for CaregiverComplete benefit finding writing | Other | Arm II (benefit finding) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (expressive disclosure), Arm II (benefit finding), Arm III (control) |
| Sham InterventionComplete writing on an emotionally neutral topic | Other | Arm III (control) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Derived from this study: PubMed 33190518Harvey 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.
- Derived from this study: PubMed 28467137Harvey 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Ko principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Support for Caregiver and Questionnaire Administration in people with Caregiver, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in comforting sensitivity (i.e. quality of social support), measured through writing exercise and anonymous online survey (time frame: Baseline to day 17). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339870, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.