Mental Health IssueNCT05087576
Chinese American Family Caregiver Writing Study
A study testing Expressive Helping and Caregiving Fact writing in people with Mental Health Issue, run by New York University at 1 site in United States.
Trial summary
The Chinese American Family Caregiver Writing Study is a Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among Chinese Americans who are providing care for family members undergoing cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Expressive Helping and Caregiving Fact writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 18 Sep 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Of Chinese descent
- Informal (i.e., uncompensated) caregiver of individual diagnosed with cancer
Who cannot join
- Inability to read or write English or Traditional/Simplified Chinese
Trial locations and contacts
1 site in 1 country.
About this study
The Chinese American Family Caregiver Writing Study is a Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among Chinese Americans who are providing care for family members undergoing cancer treatment.
Read the detailed description
Because the psychosocial health of Chinese cancer patients and their caregivers are linked, there is a need to improve health outcomes for not just the patients, but also for the caregivers. While many caregiving interventions have focused on the caregiver-patient dyad as the "the unit of care", interventions that solely target caregivers are crucial given the emotional, social, financial, and physical toll of caregiving. To address this need, investigators are testing a writing intervention, Expressive Helping (EH), with Chinese family members who are providing care for their family members diagnosed with cancer. Over four brief structured writing sessions, participants write about their cancer caregiving experiences, disclosing their emotions and providing encouragement and guidance, with the knowledge that their narratives will be shared with and used as a resource for other Chinese cancer caregivers. Participants will be adult cancer caregivers of Chinese descent. After screening and consent, eligible participants will be enrolled in a 1:1 randomized controlled trial. Assessments of psychological symptoms will occur at baseline (prior to randomization), 1-month post-intervention, and 3-month post-intervention. Investigators will also assess potential mediators and moderators of the potential intervention effects. Investigators interacting with the participants will be blind to condition assignment.
- Conditions
- Mental Health Issue
- Being tested
- Expressive Helping, Caregiving Fact writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive HelpingBehavioural
Expressive helping integrates two distinct areas of research showing that emotional disclosure over writing and support giving improves psychological well-being among healthy and clinical populations. Participants write 4 brief structured writing sessions.
Caregiving Fact writingBehavioural
Factual Writing has been used with in other writing-based interventions (e.g., expressive writing). It is also completed in 4 brief structured writing sessions.
| Study group | Role | What they receive |
|---|---|---|
| Expressive Helping writing | Experimental | During the first writing session, participants will be informed that people benefit from learning about other cancer caregivers' experiences, and that the first three sessions will consist of writing exercises designed to help them think about their cancer caregiving experiences and to prepare them for writing a helpful letter to other Chinese cancer caregivers during the fourth and final writing session. Receives: Behavioral: Expressive Helping |
| Caregiving Facts writing | Active comparator | During each week, participants in the control group will be asked to write facts about their experience with cancer caregiving (e.g., type of treatment their loved one is receiving) and will be asked to avoid writing about their emotions. Participants in this group will be told that their writing will not be shared with others outside of the research team. Receives: Behavioral: Caregiving Fact writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms assessed by the Center for Epidemiologic Studies Depression Scale
Depressive symptoms will be measured with the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Score ranges from 0-60, with higher scores indicating a worse outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Changes in life satisfaction assessed by the Satisfaction with Life Scale.
Life satisfaction will be measured by the 5-item Satisfaction with Life Scale (SWLS). Score ranges from 5-35, with higher scores indicating a better outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Changes in caregiver quality of life assessed by the Caregiver quality of life index - Cancer
Caregiver quality of life will be measured by the 35 item Caregiver quality of life index - Cancer (CQOL-C). Score ranges from 0-140, with higher scores indicating a worse outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Secondary outcomes (4)
Changes in post-traumatic growth assessed by the Post-traumatic Growth Inventory
Post-traumatic growth will be measured by the 21-item Post-traumatic Growth Inventory (PTGI). Score ranges from 0-105, with higher scores indicating a better outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Changes in sleep quality assessed by the Pittsburgh Sleep Quality Index
Sleep quality will be measured by the 19-item Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0-21, with higher scores indicating a worse outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Changes in caregiver strain assessed by the Zarit Burden Interview
Caregiver strain will be measured by the 22-item Zarit Burden Interview. Score ranges from 0-88, with higher scores indicating a worse outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Changes in intrusive thoughts assessed by the Impact of Event scale.
Intrusive thoughts will be measured by the 15 item Impact of Event scale (IES). Score ranges from 0-40, with higher scores indicating a worse outcome.
Measured: Baseline to 1-month follow-up and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Oct 2020
- Primary completion18 Sep 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087576
- Sponsor's protocol ID
- 20-1547
- Status last verified
- Sep 2022
- First submitted
- 8 Oct 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD will be protected and maintained by the study team
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese American Family Caregiver Writing Study
- ClinicalTrials.gov ID
- NCT05087576
- Acronym / sponsor ID
- 20-1547
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 18 Sep 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- 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.
The Chinese American Family Caregiver Writing Study is a Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among Chinese Americans who are providing care for family members undergoing cancer treatment.
Detailed description
Because the psychosocial health of Chinese cancer patients and their caregivers are linked, there is a need to improve health outcomes for not just the patients, but also for the caregivers. While many caregiving interventions have focused on the caregiver-patient dyad as the "the unit of care", interventions that solely target caregivers are crucial given the emotional, social, financial, and physical toll of caregiving. To address this need, investigators are testing a writing intervention, Expressive Helping (EH), with Chinese family members who are providing care for their family members diagnosed with cancer. Over four brief structured writing sessions, participants write about their cancer caregiving experiences, disclosing their emotions and providing encouragement and guidance, with the knowledge that their narratives will be shared with and used as a resource for other Chinese cancer caregivers. Participants will be adult cancer caregivers of Chinese descent. After screening and consent, eligible participants will be enrolled in a 1:1 randomized controlled trial. Assessments of psychological symptoms will occur at baseline (prior to randomization), 1-month post-intervention, and 3-month post-intervention. Investigators will also assess potential mediators and moderators of the potential intervention effects. Investigators interacting with the participants will be blind to condition assignment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Helping writing | Experimental | Behavioral: Expressive HelpingDuring the first writing session, participants will be informed that people benefit from learning about other cancer caregivers' experiences, and that the first three sessions will consist of writing exercises designed to help them think about their cancer caregiving experiences and to prepare them for writing a helpful letter to other Chinese cancer caregivers during the fourth and final writing session. |
| Caregiving Facts writing | Active comparator | Behavioral: Caregiving Fact writingDuring each week, participants in the control group will be asked to write facts about their experience with cancer caregiving (e.g., type of treatment their loved one is receiving) and will be asked to avoid writing about their emotions. Participants in this group will be told that their writing will not be shared with others outside of the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Of Chinese descent
- Informal (i.e., uncompensated) caregiver of individual diagnosed with cancer
Key exclusion criteria (1 listed)
- Inability to read or write English or Traditional/Simplified Chinese
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 |
|---|---|---|
| Expressive HelpingExpressive helping integrates two distinct areas of research showing that emotional disclosure over writing and support giving improves psychological well-being among healthy and clinical populations. Participants write 4 brief structured writing sessions. | Behavioural | Expressive Helping writing |
| Caregiving Fact writingFactual Writing has been used with in other writing-based interventions (e.g., expressive writing). It is also completed in 4 brief structured writing sessions. | Behavioural | Caregiving Facts writing |
Primary outcome
Changes in depressive symptoms assessed by the Center for Epidemiologic Studies Depression Scale
Time frame: Baseline to 1-month follow-up and 3-month follow-up
Depressive symptoms will be measured with the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Score ranges from 0-60, with higher scores indicating a worse outcome.
Changes in life satisfaction assessed by the Satisfaction with Life Scale.
Time frame: Baseline to 1-month follow-up and 3-month follow-up
Life satisfaction will be measured by the 5-item Satisfaction with Life Scale (SWLS). Score ranges from 5-35, with higher scores indicating a better outcome.
Changes in caregiver quality of life assessed by the Caregiver quality of life index - Cancer
Time frame: Baseline to 1-month follow-up and 3-month follow-up
Caregiver quality of life will be measured by the 35 item Caregiver quality of life index - Cancer (CQOL-C). Score ranges from 0-140, with higher scores indicating a worse outcome.
4 secondary outcomes
Changes in post-traumatic growth assessed by the Post-traumatic Growth Inventory
Time frame: Baseline to 1-month follow-up and 3-month follow-up
Changes in sleep quality assessed by the Pittsburgh Sleep Quality Index
Time frame: Baseline to 1-month follow-up and 3-month follow-up
Changes in caregiver strain assessed by the Zarit Burden Interview
Time frame: Baseline to 1-month follow-up and 3-month follow-up
Changes in intrusive thoughts assessed by the Impact of Event scale.
Time frame: Baseline to 1-month follow-up and 3-month follow-up
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 2 Nov 2022.
- Individual participant dataSharing planned: No. All IPD will be protected and maintained by the study team
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Helping and Caregiving Fact writing in people with Mental Health Issue, run by New York University 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 3 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 2 Nov 2022. 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. 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?
Changes in depressive symptoms assessed by the Center for Epidemiologic Studies Depression Scale (time frame: Baseline to 1-month follow-up and 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.