Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669522
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-09
Brief Title:
Psychological Factors and Oncological Outcomes of Triple-negative Breast Cancer
Sponsor:
Pius-Hospital Oldenburg
Organization:
Pius-Hospital Oldenburg
Study Overview
Official Title:
How do Psychological Factors Interact With the Oncological Outcomes of Women With Triple-negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSY-ONC TNBC
Brief Summary:
It has been established that chronic stress can take a toll on ones health Furthermore when an someone falls ill it is believed that the way that they handle stress andor 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 01012015-31122019 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 eg 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 stressfuladverse life events 2 those who present inadequateinappropriate 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
Patients treated for TNBC between 01012015-31122019 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 eg 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 stressfuladverse life events 2 those who present inadequateinappropriate 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
Detailed 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 patients 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 patients 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 diseases 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 01012015-31122019 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 inadequateinappropriate 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 hospitals Tumor Documentation Office Next patient electronic medical records will be accessed through Pius-Hospitals 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 ie name DOB but will instead contain a code which will allow the psychological data to be combined with the respective participants demographic and clinical variables for the subsequent statistical analysis After completion participants information pseudonymized will be transferred to the CRF and subsequently case data will be transferred to SPSS software version 260 for further statistical analysis
While it is known that stress can directly upregulate certain immune mechanisms it is suspected that a patients 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 diseases 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 01012015-31122019 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 inadequateinappropriate 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 hospitals Tumor Documentation Office Next patient electronic medical records will be accessed through Pius-Hospitals 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 ie name DOB but will instead contain a code which will allow the psychological data to be combined with the respective participants demographic and clinical variables for the subsequent statistical analysis After completion participants information pseudonymized will be transferred to the CRF and subsequently case data will be transferred to SPSS software version 260 for further statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None