Nurse Intervention Project

Breast Cancer Patients Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091584
• Other study ID #: CMO: 2009/293
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: December 2, 2016
• Start date: March 2010
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: July 2016
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer Patients
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Centre Nijmegen	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subscale quality of life of the questionnaire: EORTC QLQ C30	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	No
Secondary	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	After each treatment completion, during follow up; first year every 3 months, second year every 6 months	No