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

January 15, 2026 updated by: M.D. Anderson Cancer Center

Writing to Heal: A Culturally Based Brief Expressive Writing Intervention for Chinese Immigrant Breast Cancer Survivors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Write about facts regarding their cancer diagnosis and treatment
Other Names:
  • standard of care
  • standard therapy
Experimental: Arm II (self-regulation writing)
Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Behavioral, Psychological or Informational Intervention
Write about stress and coping, emotional disclosure, and benefit finding
Other: Behavioral, Psychological or Informational Intervention
Write about positive thoughts and feelings regarding their breast cancer experience
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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Behavioral, Psychological or Informational Intervention
Write about stress and coping, emotional disclosure, and benefit finding
Other: Behavioral, Psychological or Informational Intervention
Write about positive thoughts and feelings regarding their breast cancer experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL)
Time Frame: 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
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress biomarker - alpha amylase
Time Frame: 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.
Up to 6 weeks
Stress biomarker-cortisol
Time Frame: Up to 6 weeks
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
Time Frame: 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.
Up to 12 months
Perceived stress
Time Frame: Up to 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Qian Lu, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2021

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0708 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-14096 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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