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van CCT (UK)

van CCT (UK)

The influence of personality, anxiety and surgical treatment on quality of life in early stage breast cancer.

- candidate number1617
- NTR NumberNTR464
- Date ISRCTN created26-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleThe influence of personality, anxiety and surgical treatment on quality of life in early stage breast cancer.
- Scientific TitleQuality of Life in breast cancer patients: the influence of personality and surgical treatment.
- hypothesisPatients with high scores on anxiety and neuroticism will experience a lower Quality of Life after breast conserving therapy compared to modified radical mastectomy.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Anxiety, Neuroticism
- Inclusion criteriaAll women with a first event of a palpable lesion in the breast or a abnormal screening mammography.
- Exclusion criteria1. Breast cancer in the medical history; 2. Dementia; 3. T3 or T4 tumours; 4. Unable to read or write Dutch.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-sep-2002
- planned closingdate1-jan-2008
- Target number of participants500
- InterventionsThere will be no interventions in surgical treatment. Patients will choose surgical treatment together with their treating surgeon. THis choos is based on international guidelines for early stage breast cancer and on personal preferences of the patient. Before diagnosis and 1-3-6-12-24 months after diagnosis and treatment patients will complete a set of questionnaires. THese questionnaires will be the WHOQOL-100 (quality of life questionnaire), the STAI (state and trait anxiety questionnaire), the CES-D( questionnaire concerning depressive symptoms), the FAS (questionnaire concerning fatigue) and the NEO-FFI ( a personality questionnaire; only completed before diagnosis).
- Primary outcome1. Quality of life over time in breast cancer patients; 2. The influence of surgical treatment and personality.
- Secondary outcome1. Quality of life over time in breast cancer patients compared to patients with a benign breast disease; 2. The influence of personality.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Tilburg University, Faculty of Social and Behavioural Sciences, Department of Psychology and Health , St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
St. Elisabeth Hospital, Tilburg
- PublicationsN/A
- Brief summaryPURPOSE: The aim of this trial is to examine the role of patientsí personality on the relation between type of surgery and quality of life. It is hypothesized that breast cancer patients high on trait anxiety who get a breast conserving operation will subsequently have a lower QoL compared with high trait anxiety patients who receive a modified radical mastectomy, because they will worry about recurrence of cancer in the treated breast. The underlying goal is to provide women who may choose between a modified radical mastectomy and a breast conserving therapy an advise concerning their decision. One in every nine women in the Netherlands will develop breast cancer during her life. For early stage breast cancer, ablative therapy (being either a modified radical mastectomy (MRM) or an ablation of the breast with a sentinel node procedure) and breast conserving therapy (BCT) (i.e., a lumpectomy with an axillary lymph node dissection or a sentinel node procedure followed by radiotherapy) are comparable concerning overall survival. Disease-free survival is significantly shorter in patients with BCT, but recurrent cancer does not influence the overall survival. Due to early detection through screening programs and possibly by improved adjuvant treatment, for most patients breast cancer has become a chronic disease rather than a life threatening disease. Therefore, quality of life (QoL) is becoming increasingly important. Our prospective, longitudinal preliminary study has shown that trait anxiety rather than other personality characteristics (i.e., neuroticism, extraversion, opennes to experience, agreeableness, conscientiousness) determines the QoL of both breast cancer patients and benign patients, at least until six months after surgical treatment (see Preliminary results). Trait anxiety appears to have a devastating effect on QoL. To get further insight in the relationship between trait anxiety and QoL, we want to examine whether the interaction between trait anxiety and type of surgery, i.e. BCT or MRM, also plays a role in patientsí QoL. Patients with a first event of a palpable lesion in the breast or a suspect lesion on a screening mammography are elligible for inclusion. Prior to diagnosis and 1-3-6-12-24 months after diagnosis and possible treatment a set of questionnaires will be completed. Participation in the study is not known to the treating surgeon and will have no influence on the decisional proces concerning surgical treatment.
- Main changes (audit trail)
- RECORD13-sep-2005 - 26-feb-2007

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