Chinese American Cancer Survivors Writing Study

A Randomized Controlled Trial Testing Expressive Helping for Chinese American Cancer Survivors

The Chinese American Cancer Survivors Writing Study is a Randomized Controlled Trial (RCT) testing the feasibility and efficacy of the Expressive Helping (EH) intervention among Chinese American cancer survivors.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Expressive Helping; Behavioral: Expressive Writing; Behavioral: Factual Writing

Detailed Description

Chinese Americans are one of the fastest growing immigrant groups in the United States, but there is still a lack of culturally-sensitive and linguistically-appropriate resources and interventions for this group. To address this gap, the investigators will examine the efficacy and feasibility of Expressive Helping, a writing intervention designed to lead participants to write about their cancer experiences. Participants will be adult cancer survivors of Chinese descent. After screening and consent, eligible participants will be enrolled in a 1:1:1 randomized controlled trial. Assessments of psychological symptoms will occur at baseline (prior to randomization), 1-month post-intervention, 3-months post-intervention, and 6-months post-intervention.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Tsai, PhD; Phone Number: (212)998-5552; Email: will.tsai@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • New York University
      • Contact: William Tsai; Phone Number: 212-998-5552; Email: will.tsai@nyu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years old.
• Prefer speaking in Mandarin Chinese or Cantonese, and able to read and write Simplified or Traditional Chinese.
• Within 5 years after completing primary treatment or have completed primary treatment but still on medication for managing cancer-related symptoms.

Exclusion Criteria:

• Difficulties with writing
• Current active participation in support groups (i.e., attending more than once per week)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expressive Helping; Participants complete a 20-minute expressive writing session once per week for the first three weeks. During Week 4, participants complete a 20-minute peer support writing session.	Behavioral: Expressive Helping; Expressive helping involves a combination of emotional disclosure and peer support writing completed over four weeks.
Active Comparator: Expressive Writing; Participants complete a 20-minute expressive writing session once per week for four weeks.	Behavioral: Expressive Writing; Expressive writing involves emotional disclosure writing over four weeks.
Active Comparator: Factual Writing; Participants complete a 20-minute factual writing about their cancer diagnosis and treatment every week for four weeks.	Behavioral: Factual Writing; Factual writing involves writing facts about cancer treatment and experiences over four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	The number of participants screened for eligibility, percent eligible to participate, and percent of people who refuse to participate will be tracked.	through study completion, an average of 6 months
Retention rates	Percent of participants who complete each stage of the study (e.g., baseline survey, writing sessions, follow-ups) will be tracked.	through study completion, an average of 6 months
Completion rate of writing sessions	Assessed by dividing the number of writing sessions finished by the number of sessions assigned.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms assessed by the Center for Epidemiologic Studies Depression Scale	Depressive symptoms will be measured with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D). The score can range from 0-30 and higher scores indicate more depressive symptoms.	Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in anxiety symptoms assessed by the Generalized Anxiety Disorder Screener	Anxiety symptoms will be measured with the 7-item GAD-7 scale (Spitzer et al., 2006). This scale measures generalized anxiety symptoms in the past 7 days, has score ranges from 0-21 with higher scores indicating greater anxiety symptoms.	Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in health-related quality of life assessed by the Functional Assessment of Cancer Therapy: General (FACT-G).	Health-related quality of life will be measured by the 27-item FACT-G, which assess four domains: physical well-being, social well-being, emotional well-being and functional well-being. The score ranges from 0-108 with higher scores indicating better quality of life.	Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in perceived stress assessed by the Perceived Stress Scale.	Perceived stress is measured by the 10-item Perceived Stress Scale (PSS). The score ranges from 0-40 with higher scores indicating higher perceived stress.	Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in cancer-related fatigue assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue	Cancer-related fatigue is measured by the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT). The score ranges from 0-52 with higher scores indicating greater fatigue.	Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-0603; 1K01MD014750 (U.S. NIH Grant/Contract)

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