NCT02946619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

October 21, 2016

Last Update Submit

September 2, 2019

Conditions

Breast CancerBreast Neoplasms

Keywords

Chinese breast cancer survivorsexpressive writing

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (5)

  • Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)

    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 depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).

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

  • Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension

    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.

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

Enhanced self-regulation condition

EXPERIMENTAL

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.

Behavioral: Enhanced self-Regulation Condition

Interventions

Self-Regulation ConditionBEHAVIORAL
Self-regulation condition
Enhanced self-Regulation ConditionBEHAVIORAL
Enhanced self-regulation condition

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herald Cancer Association

Los Angeles, California, 91776, United States

Location

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (4)

  • Lu Q, Yeung NCY, Tsai W, Kim JHJ. The effects of culturally adapted expressive writing interventions on depressive and anxiety symptoms among Chinese American breast cancer survivors: A randomized controlled trial. Behav Res Ther. 2023 Feb;161:104244. doi: 10.1016/j.brat.2022.104244. Epub 2022 Dec 23.

    PMID: 36592575DERIVED

  • 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.

    PMID: 32485623DERIVED

  • 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.

    PMID: 31900761DERIVED

  • 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.

    PMID: 30346497DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin 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

October 21, 2016

First Posted

October 27, 2016

Study Start

June 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)