Breast Cancer, Breast Neoplasms
Conditions
Keywords
Chinese breast cancer survivors, expressive writing
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.
Interventions
BEHAVIORALEnhanced self-Regulation Condition
BEHAVIORALSelf-Regulation Condition
Sponsors
American Cancer Society, Inc.
Herald Cancer Association
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life score as assessed by the 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,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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR) | 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). 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. |
| 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 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. |
| Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D). | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | 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. |
| Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | 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. |
| 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 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. |
Countries
United States
Outcome results
None listed