ExBRAC- Expressive Writing in Breast Cancer

NCT07298980 | Not Yet Recruiting

• 1 other identifier: 2023-2888
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; quality of life; expressive writing

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  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

Study Arms (2)

Expressive Writing

EXPERIMENTAL

Expressive writing for 20 minutes, once a week, for 4 consecutive weeks. The intervention is done in addition to standard care.

Behavioral: Expressive Writing

Control group

NO INTERVENTION

No intervention. Treatment according to standard care.

Interventions

Expressive Writing BEHAVIORAL

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.

Expressive Writing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for surgery of breast cancer without neoadjuvant treatment

You may not qualify if:

• Not able to understand Swedish
• Previous breast cancer

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Surgery, Hospital of Helsingborg

Helsingborg, Skåne County, Sweden

Location

Related Links

• The ExBRAC Pilot Study

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Linnea Huss, M.D., Ph.D.

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Walming, M.D., Ph.D.

CONTACT

00464261000; sofie.walming@skane.se

Study Design

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

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: December 23, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)