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ExBRAC - the Pilot Study

Not Applicable
Completed
Conditions
Breast Cancer
Quality of Life
Interventions
Other: Expressive writing
Registration Number
NCT06230068
Lead Sponsor
Region Skane
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
25
Inclusion Criteria
  • Newly diagnosed breast cancer
Exclusion Criteria
  • Does not understand swedish

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Expressive writingExpressive writingThe 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.
Primary Outcome Measures
NameTimeMethod
Number of included patients that completed the interventionFive weeks after baseline
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Helsingborg Hospital

🇸🇪

Helsingborg, Skane, Sweden

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