Skip to content

Culturally Based Brief Expressive Writing Intervention for the Improvement of Health in Chinese Immigrant Stage 0-III Breast Cancer Survivors, Writing to Heal Study

Writing to Heal: A Culturally Based Brief Expressive Writing Intervention for Chinese Immigrant Breast Cancer Survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04754412
Enrollment
256
Registered
2021-02-15
Start date
2021-07-23
Completion date
2026-04-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

Brief 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. 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: I. 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.

Interventions

Write about stress and coping, emotional disclosure, and benefit finding

OTHERBest Practice

Write about facts regarding their cancer diagnosis and treatment

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Being diagnosed with stage 0-III breast cancer. 2. Completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years. 3. Foreign-born Chinese women (aged 18 and older) who lived in the U.S. for at least six months in the past.

Exclusion criteria

1\.

Design outcomes

Primary

MeasureTime frameDescription
Quality of life (QOL)Up to 12 monthsQuality 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

Secondary

MeasureTime frameDescription
Perceived stressUp to 12 monthsPerceived 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.
Stress biomarker - alpha amylaseUp to 6 weeksAlpha amylase will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated salivary alpha-amylase levels.
Stress biomarker-cortisolUp to 6 weeksSalivary cortisol will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated cortisol levels.
Number of medical appointments for cancer-related morbiditiesUp to 12 monthsWill 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORQian Lu

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026