Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04669522 |
| Other study ID # |
PHDW-006 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2020 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Pius-Hospital Oldenburg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Triple negative breast cancer (TNBC) is a highly heterogeneous subtype, which exhibits
aggressive clinical behavior and generally carries a poor prognosis. As it lacks hormone
receptors expression (estrogen and progesterone receptors) and amplification of the Human
epidermal growth factor receptor 2 (HER2), targeted therapies are lacking. Thus, the
identification of any modifiable factors which may influence the course of the disease is
critical both in improving the quality of care and the patient's quality of life. In addition
to lifestyle factors, such as diet and exercise habits, psychological factors, such as
cumulative lifetime stress, coping response, perceived social support, and overall
psychological well-being may also influence cancer progression.
While it is known that stress can directly upregulate certain immune mechanisms, it is
suspected that a patient's coping response, perceived social support, and general
psychological well-being may have an indirect influence on cancer progression via altered
health-related behaviors. For example, during stressful periods, alcohol consumption may
rise, sleep quality may be diminished, nutritional needs may not be properly met, and
exercise may be avoided. As a group, TNBC patients face additional challenges not experienced
by other BC patients. Due to the disease's poor prognosis, its relatively new status as a BC
subtype (first mention in 2005), and the lack of targeted treatments; patients may experience
an increased stress-response following their diagnosis. For instance, it is known that an
event induces a stress response when it involves novelty and unpredictability, a lack of
sense of control, and threats to the sense of self; elements that are clearly emphasized in
TNBC.
To promote the development of psycho oncological strategies tailored towards women in this
particular patient group, this study aims to explore any trends which might be indicative of
an interaction between psychological aspects and the oncological outcomes of patients treated
for TNBC between 01.01.2015-31.12.2019, at Pius Hospital, in Oldenburg, Germany. Because we
intend to evaluate a retrospective cohort of patients, the psychological instruments were
chosen and slightly adapted to target past events (stress across life span and social
support) and stable traits (psychological well-being, coping).
As there is an existing body of evidence supporting the relationship between stress and the
immune system, we expect to see the poorest oncological outcomes in patients who 1) have had
more adverse life events, and 2) those who present inadequate/inappropriate coping skills.
Additionally, we intend to explore if other psychological variables mentioned in the
literature, including perceived social support and psychological well-being, are also related
to the oncological outcomes in our cohort of patients.
This study combines prospective and retrospective approaches since the psychosociological
data is to be collected prospectively from a single retrospective cohort of patients.
Patients could not be randomized into groups, due to the retrospective nature of the study.
Considering that all data derived from this study will be numerical, this will be a
quantitative analysis. This research is comparative since the patients' clinical outcomes
will be analyzed in terms of psychological measures. Lastly, the present study is exploratory
as it aims to shed light on the interplay between psychological and clinical aspects in TNBC,
as psycho-oncological studies are lacking for this BC subtype.
A list of patient names will be obtained from the hospital's Tumor Documentation Office.
Next, patient electronic medical records will be accessed through Pius-Hospital's Orbis
Database program according to the name and date of birth of each patient. Demographic and
clinical variables of interest will be collected from the clinical charts and recorded on the
patient case report form (CRF).
The psychological aspects of interest will be assessed through self-reported questionnaires.
(1 computer-based and 3 paper-based questionnaires). Patients will fill out the surveys in a
proper setting where privacy will be assured. Questionnaires will not include information
which could be directly used to identify participants (i.e. name, DOB), but will instead
contain a code which will allow the psychological data to be combined with the respective
participant's demographic and clinical variables for the subsequent statistical analysis.
After completion, participant's information (pseudonymized) will be transferred to the CRF,
and subsequently case data will be transferred to SPSS (software version 26.0) for further
statistical analysis.
