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 |
| Secondary identifying numbers | NTR464 |
- 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
Scientific
St. Elisabeth Hospital
Department of Surgery
P.O. Box 90151
Tilburg
5000 LC
Netherlands
| Phone | +31 (0)13 539 2922 |
|---|---|
| afwsteeg@elisabeth.nl |
Study information
| Study design | Prospective, longitudinal preliminary study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 1. Quality of life over time in breast cancer patients 2. The influence of surgical treatment and personality |
| Secondary outcome measures | 1. Quality of life over time in breast cancer patients compared to patients with a benign breast disease 2. The influence of personality |
| Overall study start date | 01/09/2002 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 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
5000 LC
Netherlands
Sponsor information
Tilburg University (The Netherlands)
University/education
University/education
Faculty of Social and Behavioural Sciences
Department of Psychology and Health
P.O. Box 90153
Tilburg
5000 LE
Netherlands
| Website | http://www.tilburguniversity.nl/ |
|---|---|
"ROR" |
https://ror.org/04b8v1s79 |
Funders
Funder type
Hospital/treatment centre
St. Elisabeth Hospital (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
