search
Back to results

Health Benefits of Expressive Writing: Study One (Komen)

Primary Purpose

Breast Cancer, Breast Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Regulation Condition
Emotional Disclosure Condition
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Chinese breast cancer survivors expressive writing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Herald Cancer Association
  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Condition

Self-regulation Condition

Emotional Disclosure condition

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report
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).
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
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).
Change in perceived pain assessed by Brief Pain Inventory short form.
The Brief Pain Inventory-short form is a 9-item inventory which assesses the severity of pain and its impact on functioning (Cleeland, 1991).
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
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).
Change in physical symptoms as assessed by the Physical Symptoms Checklist
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).

Full Information

First Posted
May 18, 2018
Last Updated
September 2, 2019
Sponsor
University of Houston
Collaborators
Herald Cancer Association, American Cancer Society, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03546673
Brief Title
Health Benefits of Expressive Writing: Study One
Acronym
Komen
Official Title
Expressive Writing Among Chinese Breast Cancer Survivors: Study One
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
Herald Cancer Association, American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasm
Keywords
Chinese breast cancer survivors expressive writing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
Participants in the control group were asked to write for three weeks about facts regarding their cancer and its treatment for three sessions.
Arm Title
Self-regulation Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Emotional Disclosure condition
Arm Type
Experimental
Arm Description
For the emotional disclosure condition, participants were asked to write about their deepest thoughts and feelings about their cancer experience for three weeks.
Intervention Type
Behavioral
Intervention Name(s)
Self-Regulation Condition
Intervention Type
Behavioral
Intervention Name(s)
Emotional Disclosure Condition
Primary Outcome Measure Information:
Title
Change in quality of life score as assessed by Functional Assessment of Cancer Therapy Scale (FACT).
Description
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).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Secondary Outcome Measure Information:
Title
Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report
Description
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).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
Description
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).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in perceived pain assessed by Brief Pain Inventory short form.
Description
The Brief Pain Inventory-short form is a 9-item inventory which assesses the severity of pain and its impact on functioning (Cleeland, 1991).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Description
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).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in physical symptoms as assessed by the Physical Symptoms Checklist
Description
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).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Other Pre-specified Outcome Measures:
Title
Change in positive and negative affect assessed by the Positive and negative affect scale
Description
The scale contains 20 items that measure positive and negative affect (Watson, Clark, & Tellegen, 1988).
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in fear of cancer recurrence assessed by one item statement "I worry that my cancer will come back"
Description
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".
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in cancer-related morbidity
Description
Patients will prospectively record all medical visits during the period from the end of intervention through the subsequent 3 months.
Time Frame
Immediately after the intervention through 3 months after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qian Lu, Ph.D., MD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herald Cancer Association
City
Los Angeles
State/Province
California
ZIP/Postal Code
91776
Country
United States
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30656609
Citation
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.
Results Reference
derived

Learn more about this trial

Health Benefits of Expressive Writing: Study One

We'll reach out to this number within 24 hrs