NCT06367959

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
4mo left

Started Jul 2023

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2023Aug 2026

Study Start

First participant enrolled

July 27, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

April 11, 2024

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control condition

EXPERIMENTAL

Participants will be asked to write about facts regarding their cancer diagnosis and treatment in writing sessions.

Behavioral: EsaysBehavioral: Questionnaires

Intervention Condition

EXPERIMENTAL

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.

Behavioral: EsaysBehavioral: Questionnaires

Interventions

EsaysBEHAVIORAL

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.

Control conditionIntervention Condition
QuestionnairesBEHAVIORAL

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.

Control conditionIntervention Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Qian Lu, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Lu, MD, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

July 27, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations