Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01091584
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2010-03-17
Brief Title:
Nurse Intervention Project
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
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 careThe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None