Health Benefits of Expressive Writing: Study One

Study Overview
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Brief Summary
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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
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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.

Official Title
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Expressive Writing Among Chinese Breast Cancer Survivors: Study One

Conditions
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Breast Cancer, Breast Neoplasm

Intervention / Treatment
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* Behavioral: Self-Regulation Condition
* Behavioral: Emotional Disclosure Condition


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Condition<br>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<br>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<br> <br> |
| Experimental: Emotional Disclosure condition<br>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<br> <br> |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese breast cancer survivors expressive writing