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Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

Primary Purpose

Breast Cancer, Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Regulation Condition
Enhanced self-Regulation 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 breast cancer surgery within five years; and 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

Enhanced self-regulation 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 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.

Outcomes

Primary Outcome Measures

Change in quality of life score as assessed by the 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,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 Outcome Measures

Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
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.
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
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.
Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
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.
Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension
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.
Change in physical symptoms as assessed by the Physical Symptoms Checklist
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.

Full Information

First Posted
October 21, 2016
Last Updated
September 2, 2019
Sponsor
University of Houston
Collaborators
American Cancer Society, Inc., Herald Cancer Association
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1. Study Identification

Unique Protocol Identification Number
NCT02946619
Brief Title
Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors
Official Title
Reducing Psychological Burdens Among Chinese Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms
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
136 (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
Enhanced self-regulation condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Regulation Condition
Intervention Type
Behavioral
Intervention Name(s)
Enhanced self-Regulation Condition
Primary Outcome Measure Information:
Title
Change in quality of life score as assessed by the 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,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.
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Secondary Outcome Measure Information:
Title
Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
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). 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.
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 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.
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
Description
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.
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Title
Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension
Description
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.
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 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.
Time Frame
Baseline, 1 month, 3 months, and 6 months follow-ups 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 breast cancer surgery within five years; and 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
32485623
Citation
Chu Q, Wu IHC, Tang M, Tsoh J, Lu Q. Temporal relationship of posttraumatic stress disorder symptom clusters during and after an expressive writing intervention for Chinese American breast cancer survivors. J Psychosom Res. 2020 Aug;135:110142. doi: 10.1016/j.jpsychores.2020.110142. Epub 2020 May 16.
Results Reference
derived
PubMed Identifier
31900761
Citation
Chu Q, Wu IHC, Lu Q. Expressive writing intervention for posttraumatic stress disorder among Chinese American breast cancer survivors: the moderating role of social constraints. Qual Life Res. 2020 Apr;29(4):891-899. doi: 10.1007/s11136-019-02385-5. Epub 2020 Jan 3.
Results Reference
derived
PubMed Identifier
30346497
Citation
Lu Q, Gallagher MW, Loh A, Young L. Expressive Writing Intervention Improves Quality of Life Among Chinese-American Breast Cancer Survivors: A Randomized Controlled Trial. Ann Behav Med. 2018 Oct 22;52(11):952-962. doi: 10.1093/abm/kax067.
Results Reference
derived

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Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

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