ExBRAC- Expressive Writing in Breast Cancer

NCT ID: NCT07298980

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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breast cancer quality of life expressive writing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Expressive Writing

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

Group Type EXPERIMENTAL

Expressive Writing

Intervention Type 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.

Control group

No intervention. Treatment according to standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Planned for surgery of breast cancer without neoadjuvant treatment

Exclusion Criteria

* Not able to understand Swedish
* Previous breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linnea Huss, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Department of Surgery, Hospital of Helsingborg

Helsingborg, Skåne County, Sweden

Site Status

Countries

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Sweden

Central Contacts

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

Role: CONTACT

Phone: 00464261000

Email: [email protected]

Facility Contacts

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Sofie Walming, Specialty doctor, M.D., Ph.D.

Role: primary

Related Links

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Other Identifiers

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2023-2888

Identifier Type: -

Identifier Source: org_study_id