CHAMP. Dataset Name BOUNCE Breast Database Retrospective Owner organization Fundação Champalimaud Dataset description Dataset description (informal meta- data) The dataset is composed by retrospective data from breast cancer patients followed at the breast unit of the Champalimaud Clinical Center and includes biomedical, psychosocial and functional status data. The retrospective data includes medical, functional, demographic, and psychometric data collected in the Champalimaud databases and examines the correlation between biological and psychological factors. The collection of the data regards all the breast cancer patients treated with curative intent until 2018. Formal Meta-data Data description is available Standards • The breast unit is accredited by the European Society of Breast Cancer Specialists and follows international guidelines: St. Gallen Interational Expert Consensus Conference on the primary therapy of Early Breast cancer 2017 (Annals of Oncology 28: 1700–1712, 2017 doi:10.1093/annonc/mdx308) Origin ● Retrospective data: ○ Personal health records- breast unit database. ○ Neuropsychiatry unit database. Language Portuguese Size - Variety Fully structured data Type Text, Number Format CSV or Excel file Velocity Static, no plans for updating the file Storage BOUNCE data infrastructure Quality Data is precleaned but some cleaning mechanisms are needed Example N/A Data sharing and ownership Availability The data are only available to representatives of ICCS, FORTH, and SiLo as described in the data sharing agreements. Availability after the end of the project The data is only available to representatives of ICCS, FORTH and SiLo as described in the data sharing agreements during the project and one year after it. Sharing mechanisms Files exported by CHAMP. Within the BOUNCE infrastructure, the data are available through the Data Access API. Data Handling How the data are going to be used during XXXXXX’s lifetime Data is used according to data sharing agreements by ICCS, FORTH and SiLo. How the data are going to be used after XXXXXX’s lifetime After the lifetime of the BOUNCE the data are going to be used according to the guide established by the project, made available for one more year. Related WPs WP 3,4,5 Access rights Within the consortium the sharing will follow the rules described at the data sharing agreement document. Within the Champalimaud clinical center Xxxxxx Xxxx and Xxxxx Xxxxx have the role to decide who has access to the information. Ano...
CHAMP. Dataset Name BOUNCE Breast Database Prospective Owner organization Fundação Champalimaud Dataset description Dataset description (informal meta- data) The dataset is composed by prospective data from breast cancer patients followed at the breast unit of the Champalimaud Clinical Center and includes biomedical, psychosocial and functional status data. The prospective data will have additional information about sociodemographics, lifestyle, phsycological & psychosocial and cognitive function to capture resilience, well-being and disease status. The information is gathered from 3 sources: ● Personal health records: From the records data related with patient’s personal history, biological tumor characteristics, staging tests and treatment information such as radiotherapy, surgery and systemic treatment will be collected (The set of fields are described in the Appendix 1 - Table 1, 2 and 3). ● Noona platform: Will collect information related with the patients socio-demographic, psychosocial, well-being and performance status during the period of 18 months, through questionnaires (Appendix 2 & Appendix B of the document “Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a multicentre clinical pilot study” describes the variables collected in the Noona platform). ● The cognition sub-study: The study aims to evaluate cognitive function longitudinally in breast cancer patients receiving chemotherapy or only endocrine treatment. To this aim several tests will be used for neuropsychology assessment (Appendix 3) at baseline, 6 months and 1 year. All the data has long-term value with the exception of data related with patients to which the state of their disease changed during the period of study. Formal Meta-data Data dictionaries are already available Standards The breast unit is accredited by the European Society of Breast Cancer Specialists and follows international guidelines: St. Gallen Interational Expert Consensus Conference on the primary therapy of Early Breast cancer 2017 (Annals of Oncology 28: 1700–1712, 2017 doi:10.1093/annonc/mdx308). Noona is a CE-marked class 1 medical device, in accordance with standards MEDDEV 2.1/6 January 2012, IEC 62304, and EU directive 93/42/EEC. Origin ● Personal health records. ● Noona. ● Cognition sub-study. Language Portuguese Size - Variety Fully structured data Type Text, Number Format CSV or Excel file Velocity The biological and treatments information will be taken during the patients visits ...
CHAMP. Table 1 describes the data available from the CHAMP retrospective dataset. Table 1. The data available from the CHAMP dataset Data Field Description Data Type SOCIO-DEMOGRAPHIC DATA Date of birth The date of birth. Time (dd/mm/yyyy) Marital Status A code that describes the marital status. Ordinal: 1=married 2=Single 3=Common-law partner 4=Divorced 5=Widow 999= in case of missing data Education Level (number of years) A number that indicates years of education. Ordinal (999=missing data) DIAGNOSIS DATA Date of diagnosis/biopsy The date of diagnosis. Time (dd/mm/yyyy) (99/99/9999 = Missing data) Histologic Type This field describes the histological subtype of the breast cancer. Numbers are used to describe each subtype. Ordinal: 1=Invasive, NST 2=Invasive, Lobular 3=Mixed, NST and Lobular 4=Histologically special types 5=Ductal carcinoma in situ (DCIS) 6=Not applicable/Undetermined 999=Missing data Grade A description of a tumor based on how abnormal the cancer cells and tissue look under a microscope and how quickly the cancer cells are likely to grow and spread. Low-grade cancer cells look more like normal cells and tend to grow and spread more slowly than high-grade cancer cells. Numbers are used to describe each grade. Ordinal: 1=Grade 1 2=Grade 2 3=Grade 3 4=Not applicable/Undetermined 999=Missing data Estrogen Receptor A protein found inside the cells of the female reproductive tissue, some other types of tissue, and some cancer cells. The hormone estrogen will bind to the receptors inside the cells and may cause the cells to grow. Also called ER. Ordinal: 1=Negative (Describes cells that do not have a protein to which the hormone estrogen will bind) 2=Positive (Describes cells that have a receptor protein that binds the hormone estrogen.) 3=Not applicable/Undetermined 999=Missing data Progesterone receptor A protein found inside the cells of the female reproductive tissue, some other types of tissue, and some cancer cells. The hormone progesterone will bind to the receptors inside the cells and may cause the cells to grow. Also called PR. Ordinal: 1=Negative (Describes cells that do not have a protein to which the hormone progesterone will bind.) 2=Positive (Describes cells that have a protein to which the hormone progesterone will bind.) 3=Not applicable/Undetermined 999=Missing data HER- 2 receptor HER2 (human epidermal growth factor receptor 2) is a gene that can play a role in the development of breast cancer. Ordinal: 1=Negative 2=Positive 3=Not ...
CHAMP. At the Champalimaud Clinicial Center breast cancer patients are initially assessed by a nurse specialist who conducts a brief psychosocial evaluation. Therapeutic education and information about the patient supportive group mamahelp is provided. Any issue, mainly related with psychological distress will be reported to the oncologist and psycho-oncologist. A referral to a neuropsychiatry consultation will be considered after the psycho-oncology assessment. The neuropsychiatry unit will provide assessment by a psychologist, psychotherapist or psychiatrist. No comprehensive assessment of resilience is yet performed at the clinical center.
CHAMP. The data that will be provided to the BOUNCE data infrastructure were obtained in the context of a survey of existing breast cancer patient cohorts focussing on biological, socio-demographic, functional and psychological variables that could influence resilience processes. Biological variables include cancer type, treatment characteristics, and medical outcomes. Socio-demographic data includes sociological (e.g. marital status) and demographic information (e.g. age). Psychological variables refer to emotional, cognitive and relational aspects of an individual. Two databases were used to extract the biological and psychological variables of breast cancer patients that were evaluated in the neuropsychiatry unit. The type of assessment could vary based on the patients’ needs at the clinical visit. The inclusion criteria were female 40-65years of age at the time of diagnosis; Histologically confirmed invasive early or locally advanced operable breast cancer stage I to III. Concerning psychological variables the following measurements were assessed:
