VIP: Nurse Intervention Project

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01091584

Collaborator

(none)

193

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Patients	Device: distress thermometer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

193 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Other subscales [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Centre Nijmegen	Nijmegen		Netherlands	6500

Sponsors and Collaborators

Radboud University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT01091584

Other Study ID Numbers:

CMO: 2009/293

First Posted:

Mar 24, 2010

Last Update Posted:

Dec 5, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Dec 5, 2016