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

M.D. Anderson Cancer Center

Status: Enrolling

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

Treatments: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration; Other: Best Practice; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04754412

NCI-2020-14096 (Registry Identifier)

2020-0708 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 285 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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285 participants in 3 patient groups

Arm I (control writing)

Active Comparator group

Description:

Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.

Treatment:

Other: Quality-of-Life Assessment

Other: Best Practice

Other: Questionnaire Administration

Arm II (self-regulation writing)

Experimental group

Description:

Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Behavioral, Psychological or Informational Intervention

Other: Behavioral, Psychological or Informational Intervention

Arm III (self-cultivation writing)

Experimental group

Description:

Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Behavioral, Psychological or Informational Intervention

Other: Behavioral, Psychological or Informational Intervention