An efficiency study will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated for primary breast cancer by their treating…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Anxiety disorders and symptoms
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subscale quality of life of the questionnaire: EORTC QLQ C30.
Secondary outcome
Other subscalea of the EORTC QLQ C30 and the questionnaires: HADS, EORTC BR23,
SVL, ZCL.
Background summary
Every year about 90,000 people are diagnosed with cancer in the Netherlands.
Despite the increasing survival, cancer still has a major impact on someone's
life. Patients experience psychosocial distress after hearing diagnosis, during
treatment and if the disease relapses. The use of interventions for
cancer-related distress is important to reduce this distress. Distress has a
negative impact on the quality of life, the recovery during and after treatment
and may even adversely affect survival. There is insufficient attention to the
systematic approach to psychosocial problems in cancer patients in the
Netherlands. A task force discussed and studied which instrument measures
psychosocial problems best. The lastmeter (distress thermometer) had the best
results. A guideline is written to use the lastmeter for patients with cancer
and will be used in hospitals in the Netherlands. However, it is not clear what
the effects are of the use of the lastmeter on the psychosocial wellbeing of
the patient. Furthermore, it is also unknown whether the use of the lastmeter
leads to cost-effective care. This study focuses on breast cancer patients.
Patients with breast cancer are often relatively young, the treatment process
is lengthy and they have a long survival expectancy. Therefore, it is important
to optimize the psychosocial care so long term problems can be avoided. A
study on the application of the lastmeter for this patient group is thus of
importance. The research question is: what is the effect of discussion the
lastmeter by a nurse on the psychosocial well-being in patients treated for
primary breast cancer?
Study objective
An efficiency study will be conducted to evaluate the systematic use of the
distress thermometer and its discussion by a nurse as compared to the usual
care provided to outpatients who are treated for primary breast cancer by their
treating physicians . The clinical and economic impact of the use of the
lastmeter will be assessed in comparison with usual care.
Study design
A RCT with two arms will be performed.
Intervention
The intervention is to apply the distress thermometer as written in the
guideline written by 'Vereniging Integrale Kankercentra'. The distress
thermomter is collected from the experimental group and then discussed by a
trained nurse.
Study burden and risks
There is no risk associated with this study.
Geert Grooteplein 8
6525 GA Nijmegen
NL
Geert Grooteplein 8
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- histologically proven malignancy of the breast
- curative treatment
- dominated the dutch language
- Age > 18 year
Exclusion criteria
- Previously treated for a malignancy
- Psychiatric problems that adherence this study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30169.091.09 |