Clinical trial NCT01091584: Nurse Intervention Project
Official title: A Randomized Trial to Assess the (Cost) Effectiveness of the Use of the Distress Thermometer by a Nurse in Addition to Usual Care for Patients Treated With Curative Intent for Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Patients
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 193
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on 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 distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer 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 distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) 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 with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.


Eligibility criteria: 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

Primary outcomes:
measure: Subscale quality of life of the questionnaire: EORTC QLQ C30
timeFrame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months
Secondary outcomes:
measure: Other subscales
timeFrame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Centre Nijmegen
Study officials:
affiliation: University Medical Centre Nijmegen
name: P. B. Ottevanger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ploos van Amstel FK, Prins JB, van der Graaf WT, Peters ME, Ottevanger PB. The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial. BMC Cancer. 2016 Jul 25;16:520. doi: 10.1186/s12885-016-2565-x.