Psychological Factors and Oncological Outcomes of Triple-negative Breast Cancer

NCT04669522 | Unknown DMC

• 1 other identifier: PHDW-006
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Triple Negative Breast Neoplasms

Keywords

Psychooncology

Outcome Measures

Primary Outcomes (1)

• Overall Severity Score (OSS)

  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).

  1 day

Secondary Outcomes (1)

• Hazard ratio associated with OSS

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective cohort will be composed of a minimum of 50 patients diagnosed with TNBC and treated in the University Hospital for Gynecology, Pius-Hospital Oldenburg, between 01.01.2015-31.12.2019.

You may qualify if:

• 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Pius-Hospital Oldenburg: lead
• University of Oldenburg: collaborator

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Director

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12