The aim of the study will be to examine the relationship between personality, QoL and diurnal cortisol rhythm in women with a suspicion of breast cancer with regard to morbidity, prognosis and mortality.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters: personality, Quality of life, cortisol rhythm
Outcome of the study: recurrence, morbidity, mortality.
Secondary outcome
N.A.
Background summary
It concerns a study to investigate the relationship between personality, QoL
and diurnal cortisol rhythm with regard to morbidity, prognosis and mortality
in patient with breast cancer compared to patients with benign breast disease.
Women included in the questionnaires-study will be asked to participate in this
sub-study, the questionnaires will also be used in this substudy. The included
women will be asked to collect saliva at home in three days at four time points
at the baseline and after six months. The saliva collection will be done with a
special cotton swab during one minute.
Study objective
The aim of the study will be to examine the relationship between personality,
QoL and diurnal cortisol rhythm in women with a suspicion of breast cancer with
regard to morbidity, prognosis and mortality.
Study design
We want to include at least 300 women in the study (breast cancer and benign)
during a period of two years. Women with a benign diagnosis will be included as
comparison group. Based on a previous study, we know that approximately half of
all patients receive a benign diagnosis. All women will be followed-up for two
years.
Study burden and risks
N.A.
Hilvarenbeekseweg 60
5022 GC Tilburg
NL
Hilvarenbeekseweg 60
5022 GC Tilburg
NL
Listed location countries
Age
Inclusion criteria
All women with a suspicion of breast cancer
Exclusion criteria
Recurrence of disease at baseline; poor expression in the dutch langage; dementia; history of psychiatric illness, using corticosteroid medication.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL15659.008.06 |
| OMON | NL-OMON21499 |