Health Benefits of Expressive Writing: Study One

Breast Cancer Clinical Trial

— Komen  

Official title:

Expressive Writing Among Chinese Breast Cancer Survivors: Study One

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546673
• Other study ID #: 09021-02
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2019
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms

Intervention

Behavioral:
• Self-Regulation Condition

• Emotional Disclosure Condition

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas
United States	Herald Cancer Association	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Houston	American Cancer Society, Inc., Herald Cancer Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in positive and negative affect assessed by the Positive and negative affect scale	The scale contains 20 items that measure positive and negative affect (Watson, Clark, & Tellegen, 1988).	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Other	Change in fear of cancer recurrence assessed by one item statement "I worry that my cancer will come back"	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".	Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Other	Change in cancer-related morbidity	Patients will prospectively record all medical visits during the period from the end of intervention through the subsequent 3 months.	Immediately after the intervention through 3 months after the intervention
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.