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Clinical Trials/NCT06230068
NCT06230068
Completed
Not Applicable

ExBRAC - Expressive Writing in Breast Cancer - The Pilot Study

Region Skane1 site in 1 country25 target enrollmentMarch 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Region Skane
Enrollment
25
Locations
1
Primary Endpoint
Number of included patients that completed the intervention
Status
Completed
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 26, 2024
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed breast cancer

Exclusion Criteria

  • Does not understand swedish

Outcomes

Primary Outcomes

Number of included patients that completed the intervention

Time Frame: Five weeks after baseline

Study Sites (1)

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