Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Reducing Psychological Burdens Among Chinese Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946619
• Other study ID #: MRSGT-10-011-01-CPPB
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 2016

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Self-Regulation Condition

• Enhanced self-Regulation 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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.