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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05456100
Other study ID # 20-0603
Secondary ID 1K01MD014750
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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