Breast Cancer, Breast Neoplasm
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 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.
Interventions
BEHAVIORALSelf-Regulation Condition
BEHAVIORALEmotional Disclosure Condition
Sponsors
Herald Cancer Association
American Cancer Society, Inc.
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 primary medical treatment within four years * 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer-related morbidity | Immediately after the intervention through 3 months after the intervention | Patients will prospectively record all medical visits during the period from the end of intervention through the subsequent 3 months. |
| Change in fear of cancer recurrence assessed by one item statement I worry that my cancer will come back | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | 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. |
| Change in positive and negative affect assessed by the Positive and negative affect scale | Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention. | The scale contains 20 items that measure positive and negative affect (Watson, Clark, & Tellegen, 1988). |
Countries
United States
Outcome results
None listed