Health Benefits of Expressive Writing: Study One

NCT03546673 | Completed

• 1 other identifier: 09021-02
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer; Breast Neoplasm

Keywords

Chinese breast cancer survivors expressive writing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report

  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)

  Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

• Change in perceived pain assessed by Brief Pain Inventory short form.

  Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

• Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

• Change in physical symptoms as assessed by the Physical Symptoms Checklist

  Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

Other Outcomes (3)

• Change in positive and negative affect assessed by the Positive and negative affect scale

  Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

• Change in fear of cancer recurrence assessed by one item statement "I worry that my cancer will come back"

  Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

• Change in cancer-related morbidity

  Immediately after the intervention through 3 months after the intervention

Study Arms (3)

Control Condition

NO INTERVENTION

Participants in the control group were asked to write for three weeks about facts regarding their cancer and its treatment for three sessions.

Self-regulation Condition

EXPERIMENTAL

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

Emotional Disclosure condition

EXPERIMENTAL

For the emotional disclosure condition, participants were asked to write about their deepest thoughts and feelings about their cancer experience for three weeks.

Behavioral: Emotional Disclosure Condition

Interventions

Self-Regulation Condition BEHAVIORAL

Self-regulation Condition

Emotional Disclosure Condition BEHAVIORAL

Emotional Disclosure condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) having a breast cancer diagnosis
• \) completing primary medical treatment within four years
• \) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)

Sponsors & Collaborators

• University of Houston: lead
• Herald Cancer Association: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (2)

Herald Cancer Association

Los Angeles, California, 91776, United States

Location

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (1)

• Chu Q, Wong CCY, Lu Q. Acculturation Moderates the Effects of Expressive Writing on Post-Traumatic Stress Symptoms Among Chinese American Breast Cancer Survivors. Int J Behav Med. 2019 Apr;26(2):185-194. doi: 10.1007/s12529-019-09769-4.

  PMID: 30656609 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Qian Lu, Ph.D., MD

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 6, 2018
• Study Start: July 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)