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Completed

NCT Number: NCT02946619

Health Benefits of Expressive Writing 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Herald Cancer Association, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

Self-regulation condition

Behavioral

Enhanced self-Regulation Condition

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • American Cancer Society, Inc.
  • Herald Cancer Association

Registry information

Official study title

Reducing Psychological Burdens Among Chinese Breast Cancer Survivors

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2016
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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