NCT05087576

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2022

Completed
Last Updated

November 2, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

October 8, 2021

Last Update Submit

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

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.

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.

Behavioral: Caregiving Fact writing

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.

Expressive Helping 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.

Caregiving Facts writing

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations