- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06367959
Health Benefits of Writing Therapy Among Asian American Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Md Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control condition
Participants will be asked to write about facts regarding their cancer diagnosis and treatment in writing sessions.
|
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.
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.
|
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Experimental: Intervention Condition
Participants will be asked to write about different topics regarding their cancer experience.
During session 1, participants will be asked to write about the stress of having cancer and their strategies for coping with stressors associated with their cancer (i.e., stress and coping).
During session 2, participants will be asked to write about their deepest feelings regarding their cancer experience (i.e., emotional disclosure).
During session 3 and the booster session (at 9-month follow-up), participants will be asked to write about positive thoughts and feelings regarding their experience with cancer.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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: Time Frame: through study completion; an average of 1 year
|
Time Frame: through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Qian Lu, MD, PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0324
- NCI-2024-02939 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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