Chinese American Family Caregiver Writing Study

October 31, 2022 updated by: New York University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Expressive Helping writing
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
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.
Active Comparator: Caregiving Facts writing
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 1-month follow-up and 3-month follow-up
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.
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
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.
Baseline to 1-month follow-up and 3-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Changes in sleep quality assessed by the Pittsburgh Sleep Quality Index
Time Frame: Baseline to 1-month follow-up and 3-month follow-up
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
Changes in caregiver strain assessed by the Zarit Burden Interview
Time Frame: Baseline to 1-month follow-up and 3-month follow-up
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
Changes in intrusive thoughts assessed by the Impact of Event scale.
Time Frame: Baseline to 1-month follow-up and 3-month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-1547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All IPD will be protected and maintained by the study team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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