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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-14096 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0708 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (control writing) | Active Comparator | Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions. |
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| Arm II (self-regulation writing) | Experimental | Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions. |
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| Arm III (self-cultivation writing) | Experimental | Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | Write about stress and coping, emotional disclosure, and benefit finding |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Exclusion criteria include inability to provide informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Qian Lu | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39325778 | Derived | Lu Q, Lun D, Dawkins-Moultin L, Li Y, Chen M, Giordano SH, Pennebaker JW, Young L, Wang C. Study protocol for writing to heal: A culturally based brief expressive writing intervention for Chinese immigrant breast cancer survivors. PLoS One. 2024 Sep 26;19(9):e0309138. doi: 10.1371/journal.pone.0309138. eCollection 2024. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Behavioral, Psychological or Informational Intervention | Other | Write about positive thoughts and feelings regarding their breast cancer experience |
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| Best Practice | Other | Write about facts regarding their cancer diagnosis and treatment |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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