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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754412
• Other study ID #: 2020-0708
• Secondary ID: NCI-2020-1409620
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. Exclusion criteria include inability to provide informed consent

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms
• 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

Intervention

Other:
• Behavioral, Psychological or Informational Intervention
Write about stress and coping, emotional disclosure, and benefit finding
• Behavioral, Psychological or Informational Intervention
Write about positive thoughts and feelings regarding their breast cancer experience
• Best Practice
Write about facts regarding their cancer diagnosis and treatment
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 6 weeks
Secondary	Stress biomarker-cortisol	Salivary cortisol will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated cortisol levels.	Up to 6 weeks
Secondary	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.	Up to 12 months

External Links

•   M D Anderson Cancer Center