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NCT04754412 | RECRUITING | Anatomic Stage 0 Breast Cancer AJCC v8


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

Condition or disease

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 Ajc V8

Anatomic Stage II Breast Cancer Ajc V8

Anatomic Stage Iia Breast Cancer Ajc 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 Ajc V8

Prognostic Stage Ib Breast Cancer Ajcc v8

Prognostic Stage II Breast Cancer Ajc V8

Prognostic Stage Iia Breast Cancer Ajcc v8

Prognostic Stage Iib Breast Cancer Ajcc v8

Prognostic Stage III Breast Cancer Ajcc v8

Prognostic Stage IIAia Breast Cancer Ajc V8

Prognostic Stage IIB Breast Cancer Ajc V8

Prognostic Stage IIIC BREAST CANCER AJCC V8

Intervention/treatment

Behavioral, Psychological or Informational Intervention

Behavioral, Psychological or Informational Intervention

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 285 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Writing to Heal: A Culturally Based Brief Expressive Writing Intervention for Chinese Immigrant Breast Cancer Survivors
Actual Study Start Date : 2021-07-23
Estimated Primary Completion Date : 2026-04-01
Estimated Study Completion Date : 2026-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT04754412


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Locations


RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

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