Nurse Intervention Project (VIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01091584
First received: March 17, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Breast Cancer Patients
Device: distress thermometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Subscale quality of life of the questionnaire: EORTC QLQ C30


Secondary Outcome Measures:
  • Other subscales [ Time Frame: After each treatment completion, during follow up; first year every 3 months, second year every 6 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 193
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: control group
usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091584

Contacts
Contact: F. K. Ploos van Amstel, MSc, RN +31 24 3610434 F.PloosvanAmstel@onco.umcn.nl
Contact: P. B. Ottevanger, Md PhD +31 24 3610353 p.ottevanger@onco.umcn.nl

Locations
Netherlands
University Medical Centre Nijmegen Recruiting
Nijmegen, Netherlands, 6500
Contact: F. K. Ploos van Amstel, MSc, RN    +31 24 3610434    F.PloosvanAmstel@onco.umcn.nl   
Contact: P. B. Ottevanger, dr    +31 24 3610353    p.ottevanger@onco.umcn.nl   
Principal Investigator: P B Ottevanger, Dr         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: P. B. Ottevanger, Dr University Medical Centre Nijmegen
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01091584     History of Changes
Other Study ID Numbers: CMO: 2009/293
Study First Received: March 17, 2010
Last Updated: August 19, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014