Clinical trial NCT03546673: Health Benefits of Expressive Writing: Study One
Official title: Expressive Writing Among Chinese Breast Cancer Survivors: Study One
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasm
Keywords: Chinese breast cancer survivors expressive writing
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Herald Cancer Association
name: American Cancer Society, Inc.
First posted: 2018-06-06
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized controlled trial (RCT) with the aim of determining the cultural sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese breast cancer survivors.

Detailed description: The study examines the potential health benefits (i.e., physical health, psychological health, and quality of life) of this expressive writing intervention for Chinese-speaking breast cancer survivors. The study also explores the mechanism through which expressive writing confers health benefits and investigates who will benefit most from the expressive writing intervention. Chinese-speaking breast cancer survivors who have completed primary treatment will be randomly assigned to a control writing condition, a self-regulation condition, or an emotional disclosure writing condition. Health outcomes are assessed at baseline, and 1, 3, and 6 months follow-ups. Mixed qualitative-quantitative mixed methods are used to explore the effect of the intervention on health outcomes and explore the mechanisms that explain the benefits of this intervention.

Eligibility criteria: Inclusion Criteria:

* 1) having a breast cancer diagnosis
* 2) completing primary medical treatment within four years
* 3) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)

Primary outcomes:
measure: Change in quality of life score as assessed by Functional Assessment of Cancer Therapy Scale (FACT).
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Secondary outcomes:
measure: Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in perceived pain assessed by Brief Pain Inventory short form.
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in physical symptoms as assessed by the Physical Symptoms Checklist
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Other outcomes:
measure: Change in positive and negative affect assessed by the Positive and negative affect scale
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in fear of cancer recurrence assessed by one item statement "I worry that my cancer will come back"
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in cancer-related morbidity
timeFrame: Immediately after the intervention through 3 months after the intervention
Locations:
city: Los Angeles
country: United States
facility: Herald Cancer Association
state: California
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Qian Lu, Ph.D., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chu Q, Wong CCY, Lu Q. Acculturation Moderates the Effects of Expressive Writing on Post-Traumatic Stress Symptoms Among Chinese American Breast Cancer Survivors. Int J Behav Med. 2019 Apr;26(2):185-194. doi: 10.1007/s12529-019-09769-4.