Health Benefits of Expressive Writing: Study One (Komen)

Expressive Writing Among Chinese Breast Cancer Survivors: Study One

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasm
• Intervention / Treatment: Behavioral: Self-Regulation Condition; Behavioral: Emotional Disclosure Condition

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91776
      • Herald Cancer Association
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Condition; Participants in the control group were asked to write for three weeks about facts regarding their cancer and its treatment for three sessions.
Experimental: Self-regulation Condition; For the self-regulation condition, each weekly writing assignment covers a different task. During session one, participants will be asked to write about their deepest feelings and thoughts regarding their experience with breast cancer as well as its impact on their lives; in session two, participants will be asked to write about their coping strategies to deal with stressors associated with the cancer diagnosis and treatment, as well as future plans for coping with cancer-related stressors; and in session three, participants will be asked to write about positive thoughts and feelings regarding their experience with breast cancer.	Behavioral: Self-Regulation Condition
Experimental: Emotional Disclosure condition; For the emotional disclosure condition, participants were asked to write about their deepest thoughts and feelings about their cancer experience for three weeks.	Behavioral: Emotional Disclosure Condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life score as assessed by Functional Assessment of Cancer Therapy Scale (FACT).	The Functional Assessment of Cancer Therapy Scale (FACT) is a 27-item measure of health-related quality of life (Cella & Tulsky,1993), which assesses perceived life quality in four different facets, including physical well-being (7 items), social well-being (7 items), emotional well-being (6 items), and functional wellbeing (7 items).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report	The scale contains 17 items reflecting the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition -Text Revision (DSM-IV-TR) symptoms of post-traumatic stress disorder (Foa, Riggs, Dancu, & Rothbaum, 1993).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)	The FACIT-F scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week (Webster et al., 2003).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in perceived pain assessed by Brief Pain Inventory short form.	The Brief Pain Inventory-short form is a 9-item inventory which assesses the severity of pain and its impact on functioning (Cleeland, 1991).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in physical symptoms as assessed by the Physical Symptoms Checklist	The 10-item symptom questionnaire was used to assess the number of days during the last 30 days which participants had felt symptoms of acute illness such as runny nose, difficulty in breathing and soreness during the past month not due to intentional physical exercise.This measure was modified from Pennebaker (1982) and King and Emmons (1990).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in positive and negative affect assessed by the Positive and negative affect scale	The scale contains 20 items that measure positive and negative affect (Watson, Clark, & Tellegen, 1988).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in fear of cancer recurrence assessed by one item statement "I worry that my cancer will come back"	On the statement "I worry that my cancer will come back", participants rate their agreement with this statement on a 5-point scale from "not at all" to "very".	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in cancer-related morbidity	Patients will prospectively record all medical visits during the period from the end of intervention through the subsequent 3 months.	Immediately after the intervention through 3 months after the intervention

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: American Cancer Society, Inc.; Herald Cancer Association
• Investigators: Principal Investigator: Qian Lu, Ph.D., MD, University of Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Chinese breast cancer survivors expressive writing
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 09021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No