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临床试验/NCT05456100
NCT05456100进行中(未招募)不适用

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

New York University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
108
试验地点
2
主要终点
Retention rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Expressive Helping

Experimental

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.

干预措施: Expressive Helping (Behavioral)

Factual Writing

Active Comparator

Participants complete a 20-minute factual writing about their cancer diagnosis and treatment every week for four weeks.

干预措施: Factual Writing (Behavioral)

Expressive Writing

Active Comparator

Participants complete a 20-minute expressive writing session once per week for four weeks.

干预措施: Expressive Writing (Behavioral)

结局指标

主要结局

Retention rates

时间窗: 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.

Recruitment rates

时间窗: 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.

Completion rate of writing sessions

时间窗: through study completion, an average of 6 months

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

次要结局

  • 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)
  • 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)
  • 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)
  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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