Skip to main content
OpenTrials
Completed

NCT Number: NCT01091584

Nurse Intervention Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Nijmegen

Nijmegen, 6500, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

distress thermometer

Device

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study 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.

Acronym: VIP

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
Mar 24, 2010
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.