How do psychological factors interact with the oncological outcomes of women with triple-negative breast cancer?

How do psychological factors interact with the oncological outcomes of women with triple-negative breast cancer? - PSY-ONC TNBC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023519

Enrollment

Registered

2023-04-14

Start date

2021-01-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: 50 voluntary study participants, who were treated for TNBC between 01.01.2015 and 31.12.2019 at Pius-Hospital Oldenburg, will be asked to complete questionnaires on (1) stress across life spa

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female sex, confirmed diagnosis of TNBC, the ability to speak and understand German, andthe ability to give informed consent.

Exclusion criteria

Exclusion criteria: An unconfirmed TNBC diagnosis, woman whose medical records are lacking clinical and/or pathological variables of interest, a current or previous mood disorder, psychosis, anxiety disorder, psychosis, anxiety disorder, or substance abuse disorder according to the DSM V, Diagnostic and Statistical Manual of Mental Disorders, and/or current use of psychotropic agents or psychiatric drugs.

Design outcomes

Primary

Measure	Time frame
The primary objective of the pilot study is to generate the planning assumptions and hypotheses for a subsequent prospective study, in which the primary hypothesis will examine the influence of psychological factors on the oncological outcomes of patients with TNBC. More precisely, the effect of cumulative lifetime stress on TNBC recurrence will be investigated. Cumulative lifetime stress will be quantified as a score (Overall Severity Score; OSS) derived from the Stress and Adversity Inventory (STRAIN) questionnaire (Slavich and Shields, 2018). TNBC recurrence will be assessed in terms of free of disease period (FDP).	—

Measure

Time frame

The primary objective of the pilot study is to generate the planning assumptions and hypotheses for a subsequent prospective study, in which the primary hypothesis will examine the influence of psychological factors on the oncological outcomes of patients with TNBC. More precisely, the effect of cumulative lifetime stress on TNBC recurrence will be investigated. Cumulative lifetime stress will be quantified as a score (Overall Severity Score; OSS) derived from the Stress and Adversity Inventory (STRAIN) questionnaire (Slavich and Shields, 2018). TNBC recurrence will be assessed in terms of free of disease period (FDP).

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Secondary

Measure	Time frame
The secondary objectives are 1) to assess the following psychological aspects of patients: coping response, social support, and well-being, 2) to estimate the hazard ratios (HR) associated with the psychological variables, 3) to describe the study population according to their clinical characteristics at the time of diagnosis, 4) to describe the tumor stage and tumor biological characteristics of the study population (stadium, histopathology, grade, receptor status, DNA assay, etc.).	—

Measure

Time frame

The secondary objectives are 1) to assess the following psychological aspects of patients: coping response, social support, and well-being, 2) to estimate the hazard ratios (HR) associated with the psychological variables, 3) to describe the study population according to their clinical characteristics at the time of diagnosis, 4) to describe the tumor stage and tumor biological characteristics of the study population (stadium, histopathology, grade, receptor status, DNA assay, etc.).

—

Countries

Germany

Contacts

Public ContactJennifer Eidswick

Fakultät VI Medizin undGesundheitswissenschaftenUniversitätsklinik für Gynäkologie

jennifer.eidswick1@uol.de+4904412291524

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026