Chinese American Family Caregiver Writing Study

Mental Health Issue Clinical Trial

Official title:

Chinese American Family Caregiver Writing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087576
• Other study ID #: 20-1547
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 18, 2022

Study information

• Verified date: September 2022
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 18, 2022
• Est. primary completion date: September 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old
• Of Chinese descent
• Informal (i.e., uncompensated) caregiver of individual diagnosed with cancer

Exclusion Criteria:

• Inability to read or write English or Traditional/Simplified Chinese

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• Expressive Helping
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 writing
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.

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 1-month follow-up and 3-month follow-up
Primary	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.	Baseline to 1-month follow-up and 3-month follow-up
Primary	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.	Baseline to 1-month follow-up and 3-month follow-up
Secondary	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.	Baseline to 1-month follow-up and 3-month follow-up
Secondary	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.	Baseline to 1-month follow-up and 3-month follow-up
Secondary	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.	Baseline to 1-month follow-up and 3-month follow-up
Secondary	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.	Baseline to 1-month follow-up and 3-month follow-up