Clinical trial NCT02946619: Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors
Official title: Reducing Psychological Burdens Among Chinese Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Chinese breast cancer survivors
expressive writing
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Herald Cancer Association
First posted: 2016-10-27
Enrollment: 136
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 a enhanced self-regulation 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 breast cancer surgery within five years; and 3) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)

Primary outcomes:
measure: Change in quality of life score as assessed by the 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 posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
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 depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
timeFrame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
measure: Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension
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:
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, Wu IHC, Tang M, Tsoh J, Lu Q. Temporal relationship of posttraumatic stress disorder symptom clusters during and after an expressive writing intervention for Chinese American breast cancer survivors. J Psychosom Res. 2020 Aug;135:110142. doi: 10.1016/j.jpsychores.2020.110142. Epub 2020 May 16.
citation: Chu Q, Wu IHC, Lu Q. Expressive writing intervention for posttraumatic stress disorder among Chinese American breast cancer survivors: the moderating role of social constraints. Qual Life Res. 2020 Apr;29(4):891-899. doi: 10.1007/s11136-019-02385-5. Epub 2020 Jan 3.
citation: Lu Q, Gallagher MW, Loh A, Young L. Expressive Writing Intervention Improves Quality of Life Among Chinese-American Breast Cancer Survivors: A Randomized Controlled Trial. Ann Behav Med. 2018 Oct 22;52(11):952-962. doi: 10.1093/abm/kax067.