Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

September 2, 2019 updated by: Qian Lu, University of Houston

Reducing Psychological Burdens Among Chinese Breast Cancer Survivors

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 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.

Study Type

Interventional

Enrollment (Actual)

136

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

  • United States
    • California
      • Los Angeles, California, United States, 91776
        • Herald Cancer Association
    • Texas
      • Houston, Texas, United States, 77204
        • University of Houston

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 breast cancer surgery within five years; and 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.
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.
Behavioral: Self-Regulation Condition
Experimental: Enhanced self-regulation condition
For the enhanced self-regulation condition, each weekly writing assignment covers a different task. During session one, 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; during session two, 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; and in session three, participants will be asked to write about positive thoughts and feelings regarding their experience with breast cancer.
Behavioral: Enhanced self-Regulation Condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life score as assessed by the 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,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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
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).

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.
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.
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.
Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
Time Frame: 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.
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension
Time Frame: 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.
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Houston

Collaborators

American Cancer Society, Inc.
Herald Cancer Association

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.

General Publications

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

June 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRSGT-10-011-01-CPPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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