Health Benefits of Expressive Writing: Study One

Not Applicable

Completed

• Conditions: Breast Neoplasm; Breast Cancer
• Interventions: Behavioral: Emotional Disclosure Condition; Behavioral: Self-Regulation Condition

• Registration Number: NCT03546673
• Lead Sponsor: University of Houston

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emotional Disclosure condition	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.
Self-regulation Condition	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.

Primary Outcome Measures

Name	Time	Method
Change in quality of life score as assessed by Functional Assessment of Cancer Therapy Scale (FACT).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.	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).

Secondary Outcome Measures

Name	Time	Method
Change in perceived pain assessed by Brief Pain Inventory short form.	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.	The Brief Pain Inventory-short form is a 9-item inventory which assesses the severity of pain and its impact on functioning (Cleeland, 1991).
Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.	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).
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.	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).
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.	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).
Change in physical symptoms as assessed by the Physical Symptoms Checklist	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.	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).

Trial Locations

Locations (2)

University of Houston; 🇺🇸 Houston, Texas, United States

Herald Cancer Association; 🇺🇸 Los Angeles, California, United States