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

Not Applicable

Recruiting

• Conditions: Anatomic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8
• Interventions: Other: Behavioral, Psychological or Informational Intervention; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04754412
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-07-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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.

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Exclusion Criteria

1. Exclusion criteria include inability to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (self-regulation writing)	Behavioral, Psychological or Informational Intervention	Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.
Arm I (control writing)	Quality-of-Life Assessment	Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.
Arm III (self-cultivation writing)	Quality-of-Life Assessment	Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.
Arm I (control writing)	Best Practice	Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.
Arm II (self-regulation writing)	Questionnaire Administration	Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.
Arm III (self-cultivation writing)	Behavioral, Psychological or Informational Intervention	Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.
Arm III (self-cultivation writing)	Questionnaire Administration	Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.
Arm I (control writing)	Questionnaire Administration	Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.
Arm II (self-regulation writing)	Quality-of-Life Assessment	Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.

Primary Outcome Measures

Name	Time	Method
Quality of life (QOL)	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

Secondary Outcome Measures

Name	Time	Method
Number of medical appointments for cancer-related morbidities	Up to 12 months	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.
Stress biomarker-cortisol	Up to 6 weeks	Salivary cortisol will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated cortisol levels.
Perceived stress	Up to 12 months	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.
Stress biomarker - alpha amylase	Up to 6 weeks	Alpha amylase will be assessed via saliva samples. Higher levels of perceived stress are associated with dysregulated salivary alpha-amylase levels.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States