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Completed

NCT Number: NCT05087576

Chinese American Family Caregiver Writing 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expressive Helping

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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