Chinese American Cancer Survivors Writing Study

Sponsor
New York University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05456100
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
108
1
3
35.6
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expressive Helping
  • Behavioral: Expressive Writing
  • Behavioral: Factual Writing
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Randomized Controlled Trial Testing Expressive Helping for Chinese American Cancer Survivors
Actual Study Start Date :
Jul 14, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment rates [through study completion, an average of 6 months]

    The number of participants screened for eligibility, percent eligible to participate, and percent of people who refuse to participate will be tracked.

  2. Retention rates [through study completion, an average of 6 months]

    Percent of participants who complete each stage of the study (e.g., baseline survey, writing sessions, follow-ups) will be tracked.

  3. Completion rate of writing sessions [through study completion, an average of 6 months]

    Assessed by dividing the number of writing sessions finished by the number of sessions assigned.

Secondary Outcome Measures

  1. Changes in depressive symptoms assessed by the Center for Epidemiologic Studies Depression Scale [Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up]

    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.

  2. Changes in anxiety symptoms assessed by the Generalized Anxiety Disorder Screener [Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up]

    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.

  3. Changes in health-related quality of life assessed by the Functional Assessment of Cancer Therapy: General (FACT-G). [Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up]

    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.

  4. Changes in perceived stress assessed by the Perceived Stress Scale. [Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up]

    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.

  5. Changes in cancer-related fatigue assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue [Baseline to 1-month follow-up, 3-month follow-up, and 6-month follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 and having a first cancer diagnosis of stages I-III

Exclusion Criteria:
  • Difficulties with writing

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

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
  • National Institute on Minority Health and Health Disparities (NIMHD)

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:
NCT05456100
Other Study ID Numbers:
  • 20-0603
  • 1K01MD014750
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 19, 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 19, 2022