Clinical trial · Observational
Psychological Factors and Oncological Outcomes of Triple-negative Breast Cancer
How do Psychological Factors Interact With the Oncological Outcomes of Women With Triple-negative Breast Cancer?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It has been established that chronic stress can take a toll on one's health. Furthermore, when an someone falls ill, it is believed that the way that they handle stress and/or adversity can positively or negatively impact the course of their disease. Against the background of these findings, this study aims to explore how (1) cumulative lifetime stress exposure, (2) coping response, (3) perceived social support, and (4) and overall psychological well-being may relate to the oncological outcomes of women diagnosed with triple negative breast cancer (TNBC). Patients treated for TNBC between 01.01.2015-31.12.2019 at the University Clinic for Gynecology at Pius-Hospital Oldenburg will be asked to complete four questionnaires corresponding to the abovementioned psychological aspects. The results of these questionnaires will be analyzed together with the clinical patient data and tumor characteristics (such as type, size, etc.) to explore whether there is a tendency between one or more of the above-mentioned psychosocial aspects and the course of the disease (e.g. a disease recurrence within one year after the initial diagnosis (yes / no), the duration of the disease-free or progression-free period). As there is an existing body of evidence supporting a relationship between stress and the immune system, we expect to see the poorest oncological outcomes in patients who 1) have faced more stressful/adverse life events, 2) those who present inadequate/inappropriate coping skills, 3) report less social support, and 4) poorer overall psychological well-being. If a potential connection between psychosocial factors and the course of the TNBC is identified, further disease specific, it will aid in the development of disease-specific, health-promoting measures to better support this particular patient group. This is of great importance, as TNBC is generally associated with clinically aggressive behavior and a worse prognosis compared to other breast cancer subtypes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Neoplasms | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Severity Score (OSS)
- timeFrame
- 1 day
- description
- 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).
Secondary outcomes (1)
- measure
- Hazard ratio associated with OSS
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * a confirmed diagnosis of TNBC, with the ability to speak and understand German, who can give informed consent, and who were treated in the University Hospital for Gynecology, Pius-Hospital Oldenburg, between 01.01.2015-31.12.2019 Exclusion Criteria: * 1\) any woman with an unconfirmed TNBC diagnosis, 2) woman whose medical records are lacking clinical and/or pathological variables of interest, 3) patients with 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 5) all women who currently make use of psychotropic agents or psychiatric drugs.
References
Publications (0)
Data not yet available