Condition category
Cancer
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
01/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A F W van der Steeg

ORCID ID

Contact details

St. Elisabeth Hospital
Department of Surgery
P.O. Box 90151
Tilburg
5000 LC
Netherlands
+31 (0)13 539 2922
afwsteeg@elisabeth.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR464

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Prospective, longitudinal preliminary study

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2002

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All women with a first event of a palpable lesion in the breast or an abnormal screening mammography.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

500

Participant exclusion criteria

1. Breast cancer in the medical history
2. Dementia
3. T3 or T4 tumours
4. Unable to read or write Dutch

Recruitment start date

01/09/2002

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

St. Elisabeth Hospital
Tilburg
5000 LC
Netherlands

Sponsor information

Organisation

Tilburg University (The Netherlands)

Sponsor details

Faculty of Social and Behavioural Sciences
Department of Psychology and Health
P.O. Box 90153
Tilburg
5000 LE
Netherlands

Sponsor type

University/education

Website

http://www.tilburguniversity.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

St. Elisabeth Hospital (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes