Breast CancerNCT02946619
Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors
A study testing Self-Regulation Condition and Enhanced self-Regulation Condition in people with Breast Cancer and Breast Neoplasms, run by University of Houston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Self-Regulation Condition and Enhanced self-Regulation Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Houston
Houston, Texas, 77204
Herald Cancer Association
Los Angeles, California, 91776
About this study
Official title: Reducing Psychological Burdens Among Chinese Breast Cancer Survivors
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Self-Regulation Condition, Enhanced self-Regulation Condition
- Keywords
- Chinese breast cancer survivors, expressive writing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Regulation ConditionBehavioural
Enhanced self-Regulation ConditionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced self-Regulation Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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).
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.
Measured: 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
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.
Measured: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
Measured: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJun 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Herald Cancer Association
- Responsible party
- Principal investigator, Qian Lu, University of Houston
- Investigators
- Qian Lu, Ph.D., MD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946619
- Sponsor's protocol ID
- MRSGT-10-011-01-CPPB
- Status last verified
- Sep 2019
- First submitted
- 21 Oct 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Choi E, Pierce J, Xu YA, Wu D, Wong-Meli CCY, Wang C, Lu Q. Moderating Effects of Social Determinants of Health on Quality of Life in Expressive Writing Interventions Among Chinese American Breast Cancer Survivors. Psychooncology. 2026 Jun;35(6):e70511. doi: 10.1002/pon.70511.
PubMed 42210045Lu 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.
PubMed 36592575Chu 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.
PubMed 32485623Chu 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.
PubMed 31900761Lu 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.
PubMed 30346497
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Psychological Burdens Among Chinese Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02946619
- Acronym / sponsor ID
- MRSGT-10-011-01-CPPB
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Chinese breast cancer survivors, expressive writing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Herald Cancer Association
- Study start
- Jun 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Self-Regulation ConditionFor 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. |
| Enhanced self-regulation condition | Experimental | Behavioral: Enhanced self-Regulation ConditionFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Regulation Condition | Behavioural | Self-regulation condition |
| Enhanced self-Regulation Condition | Behavioural | Enhanced self-regulation condition |
Primary outcome
Change in quality of life score as assessed by the 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,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.
5 secondary outcomes
Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 42210045Choi E, Pierce J, Xu YA, Wu D, Wong-Meli CCY, Wang C, Lu Q. Moderating Effects of Social Determinants of Health on Quality of Life in Expressive Writing Interventions Among Chinese American Breast Cancer Survivors. Psychooncology. 2026 Jun;35(6):e70511. doi: 10.1002/pon.70511.
- Derived from this study: PubMed 36592575Lu 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.
- Derived from this study: PubMed 32485623Chu 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.
- Derived from this study: PubMed 31900761Chu 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.
- Derived from this study: PubMed 30346497Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Lu, Ph.D., MD principal investigator
University of Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Regulation Condition and Enhanced self-Regulation Condition in people with Breast Cancer and Breast Neoplasms, run by University of Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life score as assessed by the Functional Assessment of Cancer Therapy Scale (FACT) (time frame: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946619, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.