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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN01021331 |
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Date of registration:
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26/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The influence of personality, anxiety and surgical treatment on quality of life in early stage breast cancer
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Scientific title:
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Date of first enrolment:
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01/09/2002 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN01021331 |
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Study type:
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Observational |
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Study design:
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Prospective, longitudinal preliminary study (Quality of life)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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A F W
van der Steeg |
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Address:
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St. Elisabeth Hospital
Department of Surgery
P.O. Box 90151
5000 LC
Tilburg
Netherlands |
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Telephone:
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+31 (0)13 539 2922 |
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Email:
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afwsteeg@elisabeth.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All women with a first event of a palpable lesion in the breast or an abnormal screening mammography.
Exclusion criteria: 1. Breast cancer in the medical history
2. Dementia
3. T3 or T4 tumours
4. Unable to read or write Dutch
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast cancer, anxiety, neuroticism
Cancer
Breast cancer
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Intervention(s)
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There will be no interventions in surgical treatment. Patients will choose surgical treatment together with their treating surgeon. This choice is based on international guidelines for early stage breast cancer and on personal preferences of the patient. Before diagnosis and one, three, six, 12 and 24 months after diagnosis, treatment patients will complete a set of questionnaires. These questionnaires will be the World Health Organisation Quality of Life questionnaire (WHOQOL-100), the State and Trait Anxiety Questionnaire (STAI), the Centre for Epidemiologic Studies Depression Scale (CES-D), the Fatigue Assessment Scale (FAS) and the Neuroticism Extraversion Openness Five-Factor Inventory (NEO-FFI) (only completed before diagnosis).
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Primary Outcome(s)
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1. Quality of life over time in breast cancer patients
2. The influence of surgical treatment and personality
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Secondary Outcome(s)
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1. Quality of life over time in breast cancer patients compared to patients with a benign breast disease
2. The influence of personality
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Source(s) of Monetary Support
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St. Elisabeth Hospital (The Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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