Skip to content

Nurse Intervention Project

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091584
Acronym
VIP
Enrollment
193
Registered
2010-03-24
Start date
2010-03-31
Completion date
2016-07-31
Last updated
2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Patients

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.

Interventions

to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No

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 outcomes

Primary

MeasureTime frameDescription
Subscale quality of life of the questionnaire: EORTC QLQ C30After each treatment completion, during follow up; first year every 3 months, second year every 6 monthsSubscale quality of life of the questionnaire: EORTC QLQ C30

Secondary

MeasureTime frameDescription
Other subscalesAfter each treatment completion, during follow up; first year every 3 months, second year every 6 monthsOther subscales: * HADS : anxiety and depression * EORTC BR23 : breast cancer specific problems * SVL: Impact of Event Scale * ZCL : illness cognition questionnaire with subscales: disease benefits, acceptance and helplessness * EuroQoL6D, * Cost diary

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026