Anatomic Stage 0 Breast Cancer AJCC v8NCT04754412
Culturally Based Brief Expressive Writing Intervention for the Improvement of Health in Chinese Immigrant Stage 0-III Breast Cancer Survivors, Writing to Heal Study
A study testing Behavioral, Psychological or Informational Intervention, Best Practice and Quality-of-Life Assessment in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies the effect of a culturally based brief expressive writing intervention in improving the health of Chinese immigrant stage 0-III breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Behavioral, Psychological or Informational Intervention, Best Practice and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Being diagnosed with stage 0-III breast cancer.
- Completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years.
- Foreign-born Chinese women (aged 18 and older) who lived in the U.S. for at least six months in the past.
Who cannot join
- 1. Exclusion criteria include inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Writing to Heal: A Culturally Based Brief Expressive Writing Intervention for Chinese Immigrant Breast Cancer Survivors
This clinical trial studies the effect of a culturally based brief expressive writing intervention in improving the health of Chinese immigrant stage 0-III breast cancer survivors. Culturally based brief expressive writing interventions may help researchers learn more about the experiences of Chinese immigrant breast cancer survivors and how writing about their experiences may affect their health.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the health benefits of expressive writing compared with the control condition.
II. To characterize how acculturation moderates the effects of expressive writing interventions.
III. To identify mechanisms explaining the benefits of the interventions using mixed methods.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (CONTROL): Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.
ARM II (SELF-REGULATION): Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.
ARM III (SELF-CULTIVATION): Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.
After completion of study, patients are followed up at 6 weeks and at 6 and 12 months.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Being tested
- Behavioral, Psychological or Informational Intervention, Best Practice, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral, Psychological or Informational InterventionOther
Write about stress and coping, emotional disclosure, and benefit finding
Behavioral, Psychological or Informational InterventionOther
Write about positive thoughts and feelings regarding their breast cancer experience
Best PracticeOther
Also called standard of care, standard therapy
Write about facts regarding their cancer diagnosis and treatment
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (control writing) | Active comparator | Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (self-regulation writing) | Experimental | Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions. Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm III (self-cultivation writing) | Experimental | Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions. Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QOL)
Quality of life will be measured by the Functional Assessment of Cancer Therapy for patients with breast cancer (FACT-B). The scale contains 27 items that assess perceived QoL in four domains: physical well-being, social well-being, emotional well-being and functional well-being. Items are rated on a 5-point scale from 0 - not at all, to 4 - very much. Total scores range between 0 and 108, with higher scores indicating better quality of life
Measured: Up to 12 months
Secondary outcomes (4)
Perceived stress
Perceived stress will be measured by the Perceived Stress Scale. The current perceived stress has 4 items. Participants rate the degree to which they perceive their life situation, as described in each item, using a five-point Likert scale from 0 - never, to 4 - very often. Total scores range between 0 and 40; higher scores indicate higher perceived stress.
Measured: Up to 12 months
Stress biomarker - alpha amylase
Alpha amylase will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated salivary alpha-amylase levels.
Measured: Up to 6 weeks
Stress biomarker-cortisol
Salivary cortisol will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated cortisol levels.
Measured: Up to 6 weeks
Number of medical appointments for cancer-related morbidities
Will include appointments for non-routine cancer-related problems (e.g., lymphedema, breast symptoms, or possible recurrence) but exclude scheduled check-ups and non-routine medical appointments for other problems, such as flu symptoms.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start23 Jul 2021
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
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 Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Qian Lu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754412
- Sponsor's protocol ID
- 2020-0708
- Other IDs
- NCI-2020-14096, 2020-0708
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu Q, Lun D, Dawkins-Moultin L, Li Y, Chen M, Giordano SH, Pennebaker JW, Young L, Wang C. Study protocol for writing to heal: A culturally based brief expressive writing intervention for Chinese immigrant breast cancer survivors. PLoS One. 2024 Sep 26;19(9):e0309138. doi: 10.1371/journal.pone.0309138. eCollection 2024.
PubMed 39325778
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Writing to Heal: A Culturally Based Brief Expressive Writing Intervention for Chinese Immigrant Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04754412
- Acronym / sponsor ID
- 2020-0708
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 15 Feb 2021 (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 clinical trial studies the effect of a culturally based brief expressive writing intervention in improving the health of Chinese immigrant stage 0-III breast cancer survivors. Culturally based brief expressive writing interventions may help researchers learn more about the experiences of Chinese immigrant breast cancer survivors and how writing about their experiences may affect their health.
Detailed description
PRIMARY OBJECTIVES:
- To determine the health benefits of expressive writing compared with the control condition.
II. To characterize how acculturation moderates the effects of expressive writing interventions.
III. To identify mechanisms explaining the benefits of the interventions using mixed methods.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (CONTROL): Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.
ARM II (SELF-REGULATION): Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.
ARM III (SELF-CULTIVATION): Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.
After completion of study, patients are followed up at 6 weeks and at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (control writing) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions. |
| Arm II (self-regulation writing) | Experimental | Other: Behavioral, Psychological or Informational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions. |
| Arm III (self-cultivation writing) | Experimental | Other: Behavioral, Psychological or Informational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions. |
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)
- Being diagnosed with stage 0-III breast cancer.
- Completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years.
- Foreign-born Chinese women (aged 18 and older) who lived in the U.S. for at least six months in the past.
Key exclusion criteria (1 listed)
- 1. Exclusion criteria include inability to provide informed consent
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 |
|---|---|---|
| Behavioral, Psychological or Informational InterventionWrite about stress and coping, emotional disclosure, and benefit finding | Other | Arm II (self-regulation writing) |
| Behavioral, Psychological or Informational InterventionWrite about positive thoughts and feelings regarding their breast cancer experience | Other | Arm III (self-cultivation writing) |
| Best PracticeAlso: standard of care, standard therapyWrite about facts regarding their cancer diagnosis and treatment | Other | Arm I (control writing) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (control writing), Arm II (self-regulation writing), Arm III (self-cultivation writing) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (control writing), Arm II (self-regulation writing), Arm III (self-cultivation writing) |
Primary outcome
Quality of life (QOL)
Time frame: Up to 12 months
Quality of life will be measured by the Functional Assessment of Cancer Therapy for patients with breast cancer (FACT-B). The scale contains 27 items that assess perceived QoL in four domains: physical well-being, social well-being, emotional well-being and functional well-being. Items are rated on a 5-point scale from 0 - not at all, to 4 - very much. Total scores range between 0 and 108, with higher scores indicating better quality of life
4 secondary outcomes
Perceived stress
Time frame: Up to 12 months
Stress biomarker - alpha amylase
Time frame: Up to 6 weeks
Stress biomarker-cortisol
Time frame: Up to 6 weeks
Number of medical appointments for cancer-related morbidities
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 39325778Lu Q, Lun D, Dawkins-Moultin L, Li Y, Chen M, Giordano SH, Pennebaker JW, Young L, Wang C. Study protocol for writing to heal: A culturally based brief expressive writing intervention for Chinese immigrant breast cancer survivors. PLoS One. 2024 Sep 26;19(9):e0309138. doi: 10.1371/journal.pone.0309138. eCollection 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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 principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral, Psychological or Informational Intervention, Best Practice and Quality-of-Life Assessment in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of life (QOL) (time frame: Up to 12 months). 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 NCT04754412, 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 21 Aug 2026.