- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07298980
ExBRAC- Expressive Writing in Breast Cancer (ExBRAC)
May 8, 2026 updated by: Region Skane
Expressive Writing in Breast Cancer - The ExBRAC Trial
The study is a randomized trial designed to examine whether an "expressive writing" intervention can affect the quality of life in patients recently diagnosed with breast cancer.
The method "expressive writing" consists of writing about the breast cancer or other related subjects during 20 minutes, once a week for four consecutive weeks.
The impact on quality of life will be assessed by having participants complete questionnaires at three different time points during the study.
The questionnaire will be developed using a clinimetric approach, based on semi-structured interviews with breast cancer patients.
The themes emerging from these interviews will be used to formulate the questions.
Additionally, well-known quality-of-life measurement instruments and registry data with clinically relevant information-such as tumor stage and treatment-will be incorporated.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
272
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
-
-
Skåne County
-
Helsingborg, Skåne County, Sweden
- Department of Surgery, Hospital of Helsingborg
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Planned for surgery of breast cancer without neoadjuvant treatment
Exclusion Criteria:
- Not able to understand Swedish
- Previous breast cancer
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Expressive Writing
Expressive writing for 20 minutes, once a week, for 4 consecutive weeks.
The intervention is done in addition to standard care.
|
Expressive writing means that the patient writes privately about the cancer or other related subject for 20 minutes.
This will be repeated once a week for 4 weeks.
The writing should be done in a place free from distractions and on the patients' mother tongue.
The text will not be collected.
|
|
No Intervention: Control group
No intervention.
Treatment according to standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: At the 12 months follow-up
|
According to EQ-5D-5L VAS.
The scale ranges from 0-100 where 0 is "worst possible health" and 100 is "best possible health".
|
At the 12 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linnea Huss, M.D., Ph.D., Lund University
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.
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)
February 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
September 18, 2025
First Submitted That Met QC Criteria
December 8, 2025
First Posted (Actual)
December 23, 2025
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-2888
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Breast Cancer
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of Colorado, DenverCompletedStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast CancerUnited States
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerCanada
-
Mayo ClinicMarker Therapeutics, Inc.CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Central FloridaFlorida Department of HealthRecruitingBreast Cancer | Breast Cancer Female | Breast Cancer Diagnosis | Breast Cancer Survivors | Breast Cancer Detection | Breast Cancer AwarenessUnited States
Clinical Trials on Expressive Writing
-
Royal Cornwall Hospitals TrustUniversity of PlymouthRecruiting
-
Trustees of Princeton UniversityCompleted
-
New York UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Recruiting
-
University of Texas at AustinUnknownPost Traumatic Stress DisorderUnited States
-
Minneapolis Veterans Affairs Medical CenterUnited States Department of Defense; US Department of Veterans AffairsCompletedPosttraumatic Stress DisorderUnited States
-
Changzhi Medical CollegeCompletedStress, PsychologicalChina
-
Philipps University Marburg Medical CenterCompletedHealth Care UtilizationGermany
-
University of Roma La SapienzaAzienda Policlinico Umberto ICompleted
-
Syracuse UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedDepression | Diabetes Mellitus | StressUnited States
-
Intermountain Health Care, Inc.Unknown