The role of personality and quality of life (QOL) on morbidity, mortality, and health care consumption in breast cancer.|
|- candidate number||4584|
|- NTR Number||NTR1555|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2008|
|- Secondary IDs||NL15659.008.06 METC|
|- Public Title||The role of personality and quality of life (QOL) on morbidity, mortality, and health care consumption in breast cancer.|
|- Scientific Title||The role of personality and quality of life on morbidity, mortality, and health care consumption in breast cancer.|
|- hypothesis||There is a relationship between personality factors and prognosis (i.e., mortality; recurrence of disease), also after correction for tumor staging. |
Both personality and QOL play a role in the relationship between chemotherapy/radiotherapy and morbidity (disease-specific side effects of treatment and symptoms; fatigue, depressive symptoms, state anxiety).
Personality factors and QOL predict the extent of health care consumption.
|- Healt Condition(s) or Problem(s) studied||Mamma carcinoma, Breast cancer, Quality of life, Personality |
|- Inclusion criteria||1. Women visiting for the first time the department of surgery of the participating hospitals with (a suspicion of) breast cancer.
|- Exclusion criteria||1. Recurrence of disease at baseline|
2. Poor expression in the Dutch language
4. A history of psychiatric illness
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-mei-2007|
|- planned closingdate||1-mei-2011|
|- Target number of participants||600|
|- Interventions||There will be no interventio in this study, women who receive a diagnosis of breast cancer will be treated as usual. |
Before diagnosis (BD) and 1, 3, 6, 12 and 24 months after diagnosis and treatment patients will complete a set of questionnaires; the WHOQOL-bref (QOL; BD, 12m, 24m), the STAI state (state anxiety; all timepoints) and STAI trait (trait anxiety; BD, 12m), the CES-D (depressive symptoms; all timepoints), the FAS (fatigue; all timepoints), the neuroticism part of NEO-FFI (neuroticism; BD, 12m), the DS14 (Type-D personality; BD, 12m), the LPM-Anx (psychological denial; BD), the CIDI (diagnostic interview; 12m) and the EORTC-QLQ-BR23 (health status, only breast cancer patients; 1m, 3m, 6m, 12m, 24m).
|- Primary outcome||1. The relationship between personality factors and prognosis in breast cancer patients|
2. The role of QOL and personality factors in the relationship between chemotherapy/radiotherapy/hormone therapy and morbidity (side-effects of treatment, fatigue, depressive symptoms, anxiety)
3. The relationship between personality factors and health care consumption
|- Secondary outcome||The stability of personality factors|
before diagnosis, and 1, 3, 6, 12, and 24 months after diagnosis.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. L. Esch, van|
|- CONTACT for SCIENTIFIC QUERIES|| J.A. Roukema|
|- Sponsor/Initiator ||University of Tilburg |
(Source(s) of Monetary or Material Support)
|- Brief summary||Although still a large percentage of breast cancer patients dies within five years after diagnosis, breast cancer has become a chronic disease instead of a live threatening cancer for many patients, possibly due to early detection through screening programs and to recent improvements in chemotherapy. Therefore, along with mortality, quality of life (QOL) has become an important endpoint of treatment. QOL refers to patientsí evaluation of their functioning in a range of domains, such as physical, psychological, and social. A related concept that is frequently measured in breast cancer patients is health status (HS), i.e., patientsí functioning. Studies have shown that both QOL and HS of breast cancer patients are impaired and predicted by morbidity, operationalized as fatigue, anxiety, and depressive symptoms. In addition, health care consumption was higher in breast cancer survivors. Apart from QOL and HS as endpoint of treatment, they have also been shown to predict morbidity, e.g., operationalized as rehospitalisation, and mortality. |
Furthermore, personality, i.e., Type D, is recognized as important factor in cardiovascular diseases for morbidity and mortality. In breast cancer, trait anxiety has recently been found to play a role in QOL and depressive symptoms and fatigue. In addition, especially neuroticism has been examined in relation to HS, depression, anxiety, distress, and health care utilization in cancer. However, apart from the studies mentioned, personality factors have hardly been studied in breast cancer. Also, the role of QOL as predictor of morbidity, mortality, and health care consumption has not been examined in breast cancer. Therefore, the aim of the present study will be to examine the role of personality factors and QOL as predictors of morbidity (depressive symptoms (objective and subjective), fatigue, state anxiety (objective and subjective), arm and sexual problems, recurrence), mortality, and health care consumption in breast cancer patients above and beyond disease severity.
|- Main changes (audit trail)|
|- RECORD||24-nov-2008 - 2-dec-2008|
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