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Enrolling by invitation NCT07298980

ExBRAC- Expressive Writing in Breast Cancer

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expressive Writing.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Expressive Writing in Breast Cancer - The ExBRAC Trial

Overview

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.

Interventions

  • Behavioral Expressive Writing
    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.

Primary outcome measures

  • Health-related quality of life [Time frame: At the 12 months follow-up]

Eligibility criteria

Inclusion criteria

  • Planned for surgery of breast cancer without neoadjuvant treatment

Exclusion criteria

  • Not able to understand Swedish
  • Previous breast cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Sweden · 1 center
  • Department of Surgery, Hospital of Helsingborg — Helsingborg

Identifiers

NCT: NCT07298980 · 2023-2888

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗