Chinese American Family Caregiver Writing Study
1 other identifier
interventional
67
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2022
CompletedNovember 2, 2022
September 1, 2022
2 years
October 8, 2021
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (4)
Changes in post-traumatic growth assessed by the Post-traumatic Growth Inventory
Baseline to 1-month follow-up and 3-month follow-up
Changes in sleep quality assessed by the Pittsburgh Sleep Quality Index
Baseline to 1-month follow-up and 3-month follow-up
Changes in caregiver strain assessed by the Zarit Burden Interview
Baseline to 1-month follow-up and 3-month follow-up
Changes in intrusive thoughts assessed by the Impact of Event scale.
Baseline to 1-month follow-up and 3-month follow-up
Study Arms (2)
Expressive Helping writing
EXPERIMENTALDuring 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 COMPARATORDuring 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Of Chinese descent
- Informal (i.e., uncompensated) caregiver of individual diagnosed with cancer
You may not qualify if:
- Inability to read or write English or Traditional/Simplified Chinese
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University
New York, New York, 10003, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 21, 2021
Study Start
October 1, 2020
Primary Completion
September 18, 2022
Study Completion
September 18, 2022
Last Updated
November 2, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
All IPD will be protected and maintained by the study team