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Nurse Intervention Project (VIP)

Primary Purpose

Breast Cancer Patients

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
distress thermometer
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer Patients

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Centre Nijmegen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intervention group

control group

Arm Description

The intervention is 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.

usual care

Outcomes

Primary Outcome Measures

Subscale quality of life of the questionnaire: EORTC QLQ C30
Subscale quality of life of the questionnaire: EORTC QLQ C30

Secondary Outcome Measures

Other subscales
Other 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

Full Information

First Posted
March 17, 2010
Last Updated
December 2, 2016
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01091584
Brief Title
Nurse Intervention Project
Acronym
VIP
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
The intervention is 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Device
Intervention Name(s)
distress thermometer
Intervention Description
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
Primary Outcome Measure Information:
Title
Subscale quality of life of the questionnaire: EORTC QLQ C30
Description
Subscale quality of life of the questionnaire: EORTC QLQ C30
Time Frame
After each treatment completion, during follow up; first year every 3 months, second year every 6 months
Secondary Outcome Measure Information:
Title
Other subscales
Description
Other 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
Time Frame
After each treatment completion, during follow up; first year every 3 months, second year every 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. B. Ottevanger, Dr
Organizational Affiliation
University Medical Centre Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Nijmegen
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27455960
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.
Results Reference
derived

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Nurse Intervention Project

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