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

ISRCTN	ISRCTN01021331
DOI	https://doi.org/10.1186/ISRCTN01021331
Protocol serial number	NTR464
Sponsor	Tilburg University (The Netherlands)
Funder	St. Elisabeth Hospital (The Netherlands)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 01/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A F W van der Steeg
Scientific

St. Elisabeth Hospital
Department of Surgery
P.O. Box 90151
Tilburg
5000 LC
Netherlands

Phone	+31 (0)13 539 2922
Email	afwsteeg@elisabeth.nl

Study information

Primary study design	Observational
Study design	Prospective, longitudinal preliminary study
Secondary study design	Single-centre
Scientific title
Study objectives	The aim of this trial is to examine the role of patient personality on the relation between type of surgery and quality of life. It is hypothesised that breast cancer patients high on trait anxiety who get a breast conserving operation will subsequently have a lower Quality of Life (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 advice 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, QoL is becoming increasingly important. Hypothesis: Patients with high scores on anxiety and neuroticism will experience a lower Quality of Life after breast conserving therapy compared to modified radical mastectomy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer, anxiety, neuroticism
Intervention	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).
Intervention type	Other
Primary outcome measure(s)	1. Quality of life over time in breast cancer patients 2. The influence of surgical treatment and personality
Key secondary outcome measure(s)	1. Quality of life over time in breast cancer patients compared to patients with a benign breast disease 2. The influence of personality
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	500
Key inclusion criteria	All women with a first event of a palpable lesion in the breast or an abnormal screening mammography.
Key exclusion criteria	1. Breast cancer in the medical history 2. Dementia 3. T3 or T4 tumours 4. Unable to read or write Dutch
Date of first enrolment	01/09/2002
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

St. Elisabeth Hospital

Tilburg
5000 LC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan