Nurse Intervention Project (VIP)

December 2, 2016 updated by: Radboud University Medical Center

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500
        • University Medical Centre Nijmegen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
usual care
Active Comparator: intervention group
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.
Device: distress thermometer
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Subscale quality of life of the questionnaire: EORTC QLQ C30
After each treatment completion, during follow up; first year every 3 months, second year every 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other subscales
Time Frame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months

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
After each treatment completion, during follow up; first year every 3 months, second year every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: P. B. Ottevanger, Dr, University Medical Centre Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO: 2009/293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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