Chinese American Family Caregiver Writing Study

Sponsor
New York University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05087576
Collaborator
(none)
67
1
2
24.4
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expressive Helping
  • Behavioral: Caregiving Fact writing
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Chinese American Family Caregiver Writing Study
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Oct 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in depressive symptoms assessed by the Center for Epidemiologic Studies Depression Scale [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. [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 [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 Outcome Measures

  1. Changes in post-traumatic growth assessed by the Post-traumatic Growth Inventory [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 [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 [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University New York New York United States 10003

Sponsors and Collaborators

  • New York University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
William Tsai, Assistant Professor, New York University
ClinicalTrials.gov Identifier:
NCT05087576
Other Study ID Numbers:
  • 20-1547
First Posted:
Oct 21, 2021
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 7, 2022