- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03546673
Health Benefits of Expressive Writing: Study One (Komen)
September 2, 2019 updated by: Qian Lu, University of Houston
Expressive Writing Among Chinese Breast Cancer Survivors: Study One
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 91776
- Herald Cancer Association
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Texas
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Houston, Texas, United States, 77204
- University of Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Condition
Participants in the control group were asked to write for three weeks about facts regarding their cancer and its treatment for three sessions.
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Experimental: 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.
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Experimental: 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.
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What is the study measuring?
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).
Time Frame: 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).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report
Time Frame: 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).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
Time Frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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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).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in perceived pain assessed by Brief Pain Inventory short form.
Time Frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The Brief Pain Inventory-short form is a 9-item inventory which assesses the severity of pain and its impact on functioning (Cleeland, 1991).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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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).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in physical symptoms as assessed by the Physical Symptoms Checklist
Time Frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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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).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in positive and negative affect assessed by the Positive and negative affect scale
Time Frame: 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).
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in fear of cancer recurrence assessed by one item statement "I worry that my cancer will come back"
Time Frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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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".
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in cancer-related morbidity
Time Frame: Immediately after the intervention through 3 months after the intervention
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Patients will prospectively record all medical visits during the period from the end of intervention through the subsequent 3 months.
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Immediately after the intervention through 3 months after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qian Lu, Ph.D., MD, University of Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 18, 2018
First Submitted That Met QC Criteria
June 1, 2018
First Posted (Actual)
June 6, 2018
Study Record Updates
Last Update Posted (Actual)
September 4, 2019
Last Update Submitted That Met QC Criteria
September 2, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09021-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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