Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

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 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.

Official Title
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Reducing Psychological Burdens Among Chinese Breast Cancer Survivors

Conditions
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Breast Cancer, Breast Neoplasms

Intervention / Treatment
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* Behavioral: Self-Regulation Condition
* Behavioral: Enhanced self-Regulation Condition


Participation Criteria
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Eligibility Criteria
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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)

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: Enhanced self-regulation condition<br>For the enhanced self-regulation condition, each weekly writing assignment covers a different task. During session one, 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; during session two, 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; and in session three, participants will be asked to write about positive thoughts and feelings regarding their experience with breast cancer. | Behavioral: Enhanced self-Regulation 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 the 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,score range 0 - 28), social well-being (7 items, score range 0 - 28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). A higher subscale score indicates better functioning in the corresponding domain. Total score is computed by summing up the scores of the four subscales. Total score ranges from 0 to 108. A higher score indicates better quality of life. | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR) | 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). Score can be reported in terms of total score or the score of the three subscales (Re-experiencing, Avoidance and Hyperarousal). The score ranges for the three sub-scales are: Re-experiencing symptoms (5 items, 0-15), Avoidance symptoms (7 items, 0 -21) and Hyperarousal symptoms (5 items, 0-15). Each subscale score is computed by summing up the scores of the corresponding items. For each subscale, a higher score indicates more severe symptoms. The total score is computed by summing up the scores of the three subscales. The total score ranges from 0 to 51. A higher score indicated more severe PTSD symptoms. | 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 scale contains 13 items. Total score is computed by summing up the scores of all the 13 items. The total score ranges from 0 to 52. A higher score indicates more severe fatigue symptoms. | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | 
| Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D). | The scale contains 10 items. Total score is computed by summing up the scores of all the 10 items. Total score ranges from 0 to 30. A higher scores indicates more severe depression symptoms. | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | 
| Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension | The scale contains 6 items. Total score is computed by summing up the scores of all the 6 items. Total score ranges from 0 - 24. A higher score indicates more severe anxiety symptoms. | 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 scale contains 10 items. Total score is computed by summing up the scores of all the 10 items. Total score ranges from 0 - 300. A higher score indicates more severe physical symptoms. | 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