Culturally Based Brief Expressive Writing Intervention for the Improvement of Health in Chinese Immigrant Stage 0-III Breast Cancer Survivors, Writing to Heal Study
Study Details
Study Description
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:
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To determine the health benefits of expressive writing compared with the control condition.
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To characterize how acculturation moderates the effects of expressive writing interventions.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I (control writing) Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions. |
Other: Best Practice
Write about facts regarding their cancer diagnosis and treatment
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Arm II (self-regulation writing) Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions. |
Other: Behavioral, Psychological or Informational Intervention
Write about stress and coping, emotional disclosure, and benefit finding
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Arm III (self-cultivation writing) Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions. |
Other: Behavioral, Psychological or Informational Intervention
Write about positive thoughts and feelings regarding their breast cancer experience
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- 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
- Perceived stress [Up to 12 months]
Perceived stress will be measured by the Perceived Stress Scale. The scale contains 10 items that assess perception of stress. 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Woman (aged 18 and older) diagnosed with stage 0-III breast cancer
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Completed primary treatment, including surgery, chemotherapy, and/or radiation therapy, within the preceding 5 years
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Comfortable writing and speaking in Chinese. Chinese includes Mandarin and Cantonese, which are 2 different dialects but have the same written characters
Exclusion Criteria:
- Exclusion criteria include inability to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Qian Lu, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2020-0708
- NCI-2020-14096
- 2020-0708