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Completed

NCT Number: NCT03546673

Health Benefits of Expressive Writing: 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasm 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 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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Self-regulation condition

Behavioral

Emotional Disclosure Condition

Behavioral

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  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 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).

  3. 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.

    The Brief Pain Inventory-short form is a 9-item inventory which assesses the severity of pain and its impact on functioning (Cleeland, 1991).

  4. 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.

    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).

  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 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).

Other outcomes

  1. 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).

  2. 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.

    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".

  3. Change in cancer-related morbidity

    Time frame: Immediately after the intervention through 3 months after the intervention

    Patients will prospectively record all medical visits during the period from the end of intervention through the subsequent 3 months.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • American Cancer Society, Inc.
  • Herald Cancer Association

Registry information

Official study title

Expressive Writing Among Chinese Breast Cancer Survivors: Study One

Acronym: Komen

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2018
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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