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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06367959
Other study ID # 2021-0324
Secondary ID NCI-2024-02939
Status Recruiting
Phase N/A
First received
Last updated
Start date July 27, 2023
Est. completion date August 31, 2026

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Qian Lu, MD, PHD
Phone (713) 745-8324
Email qlu@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health.


Description:

Primary Objective: To determine the effects of writing therapy on QOL and perceived stress at the 6- and 12-month follow-ups. Secondary Objective: To discover the effects of writing therapy on stress biomarkers and perceived stress at the 3-month follow-up. To explore the psychosocial and cultural mechanisms responsible for the benefits of writing therapy by using mixed methods.


Recruitment information / eligibility

Status Recruiting
Enrollment 192
Est. completion date August 31, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (aged 18 and older) diagnosed with stage 0-III cancer (or acute leukemia in remission/ chronic myeloid leukemia in chronic phase). - Self-identified as Asian, Asian Americans, any Asian or Asian American subgroup (Chinese, Vietnamese, Indian, Korean, etc.) ethnic/cultural background - Completed primary treatment, including surgery, chemotherapy, and/or radiation therapy, immunotherapy, or targeted therapy within the preceding 5 years. - Comfortable reading in English or in Chinese. Exclusion Criteria: - Inability to provide informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Esays
Participants will write about their experiences One (1) time each week for 3 weeks at the beginning of the study and then 1 more time 9 months later. Participants will be asked to write about their experiences with cancer in English or Chinese and to write as much as they can for about 20-30 minutes for each essay.
Questionnaires
Participants will answer a questionnaire at the beginning of the study and then 3, 6, and 12 months later. Participants will also answer a questionnaire about their thoughts on writing and on the study after they complete the third essay.

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Time Frame: through study completion; an average of 1 year
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