Chinese American Cancer Survivors Writing Study

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456100
• Other study ID #: 20-0603
• Secondary ID: 1K01MD014750
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: New York University
• Contact: William Tsai, PhD
• Phone: (212)998-5552
• Email: will.tsai[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Expressive Helping
Expressive helping involves a combination of emotional disclosure and peer support writing completed over four weeks.
• Expressive Writing
Expressive writing involves emotional disclosure writing over four weeks.
• Factual Writing
Factual writing involves writing facts about cancer treatment and experiences over four weeks.

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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