NCT04754412

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 23, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

February 10, 2021

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Perceived stress

    Up to 12 months

  • Stress biomarker - alpha amylase

    Up to 6 weeks

  • Stress biomarker-cortisol

    Up to 6 weeks

  • Number of medical appointments for cancer-related morbidities

    Up to 12 months

Study Arms (3)

Arm I (control writing)

ACTIVE COMPARATOR

Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.

Other: Best PracticeOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (self-regulation writing)

EXPERIMENTAL

Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.

Other: Behavioral, Psychological or Informational InterventionOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm III (self-cultivation writing)

EXPERIMENTAL

Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.

Other: Behavioral, Psychological or Informational InterventionOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Write about facts regarding their cancer diagnosis and treatment

Also known as: standard of care, standard therapy
Arm I (control writing)

Ancillary studies

Also known as: Quality of Life Assessment
Arm I (control writing)Arm II (self-regulation writing)Arm III (self-cultivation writing)

Ancillary studies

Arm I (control writing)Arm II (self-regulation writing)Arm III (self-cultivation writing)

Write about stress and coping, emotional disclosure, and benefit finding

Arm II (self-regulation writing)

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with stage 0-III breast cancer.
  • Completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years.
  • Foreign-born Chinese women (aged 18 and older) who lived in the U.S. for at least six months in the past.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Practice Guidelines as TopicStandard of Care

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health Care

Study Officials

  • Qian Lu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

July 23, 2021

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations