Breast CancerKomenNCT03546673
Health Benefits of Expressive Writing: Study One
A study testing Self-Regulation Condition and Emotional Disclosure Condition in people with Breast Cancer and Breast Neoplasm, 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 Neoplasm
- What is being tested?
- Self-Regulation Condition and Emotional Disclosure Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Oct 2011
- 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 primary medical treatment within four years
- 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: Expressive Writing Among Chinese Breast Cancer Survivors: Study One
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 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.
- Conditions
- Breast Cancer, Breast Neoplasm
- Being tested
- Self-Regulation Condition, Emotional Disclosure 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
Emotional Disclosure 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 |
| 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. Receives: Behavioral: Emotional Disclosure 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 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).
Measured: 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
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).
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 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).
Measured: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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).
Measured: 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)
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).
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 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).
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 posted6 Jun 2018
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Herald Cancer Association, American Cancer Society, Inc.
- 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
- NCT03546673
- Sponsor's protocol ID
- 09021-02
- Acronym
- Komen
- Status last verified
- Sep 2019
- First submitted
- 18 May 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30656609
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
- Expressive Writing Among Chinese Breast Cancer Survivors: Study One
- ClinicalTrials.gov ID
- NCT03546673
- Acronym / sponsor ID
- Komen / 09021-02
- Conditions
- Breast Cancer, Breast Neoplasm
- Keywords
- Chinese breast cancer survivors expressive writing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Herald Cancer Association, American Cancer Society, Inc.
- Study start
- Jul 2009 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Jun 2018 (actual)
- 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 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.
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. |
| Emotional Disclosure condition | Experimental | Behavioral: Emotional Disclosure ConditionFor the emotional disclosure condition, participants were asked to write about their deepest thoughts and feelings about their cancer experience for three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
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 |
| Emotional Disclosure Condition | Behavioural | Emotional Disclosure condition |
Primary outcome
Change in quality of life score as assessed by 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), social well-being (7 items), emotional well-being (6 items), and functional wellbeing (7 items).
5 secondary outcomes
Change in Post-traumatic stress symptoms assessed by The PTSD Symptom Scale - Self Report
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 perceived pain assessed by Brief Pain Inventory short form.
Time frame: 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)
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 30656609Chu 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.
- 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 Emotional Disclosure Condition in people with Breast Cancer and Breast Neoplasm, 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 3 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 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 NCT03546673, which also lists 1 linked publication.
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.