ExBRAC - Expressive Writing in Breast Cancer

Breast Cancer Clinical Trial

— ExBRAC  

Official title:

ExBRAC - Expressive Writing in Breast Cancer - Bröstcancer Och Intensivt Skrivande

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230068
• Other study ID #: 2023-07984-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Region Skane
• Contact: Sofie Walming, M.D., Ph. D.
• Phone: 00464261000
• Email: sofie.walming[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The EXBRAC pilot study will investigate the quality of life of patients with breast cancer, and the effect of an intervention with expressive writing. This is a pilot study with two purposes, the first is to create a questionnaire specifically developed for the ExBRAC study, and the second to evaluate the feasibility of the expressive writing.

Description:

In the first stage of the study, patients newly diagnosed with breast cancer will be interviewed using a semi-structured method. Based on the transcriptions from the interviews, themes will be gathered and transformed into questions. The questions will be compiled into a questionnaire and an expert group will review the questionnaire to ensure no topic is lacking and an adequate number of response options is present. Lastly, the questionnaire will be face-to-face validated, meaning a patient completes it with a research nurse present to apprehend any ambiguities or questions needing clarification.

In the second part of the pilot study, patients will be included to test the feasibility of the interventions consisting of expressive writing. The intervention consists of expressive writing during 20 minutes. The writing should be of the breast cancer, the treatment or other related topics. The patient is invited to write once every week in a separate place. The intervention ends after four weeks. The written text is not collected. In the pilot study, the intervention will be followed by a telephone call about five weeks after inclusion. To test the feasibility of the intervention, 20 to 25 included patient is considered sufficient.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed breast cancer

Exclusion Criteria:

• Does not understand swedish

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life

Intervention

Other:
• Expressive writing
See description under arm/group description.

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of included patients that completed the intervention		Five weeks after baseline