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Nurse Intervention Project

NCT ID: NCT01091584

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

distress thermometer

Intervention Type 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

control group

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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P. B. Ottevanger, Dr

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Nijmegen

Locations

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University Medical Centre Nijmegen

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Ploos van Amstel FK, Prins JB, van der Graaf WT, Peters ME, Ottevanger PB. The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial. BMC Cancer. 2016 Jul 25;16:520. doi: 10.1186/s12885-016-2565-x.

Reference Type DERIVED
PMID: 27455960 (View on PubMed)

Other Identifiers

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CMO: 2009/293

Identifier Type: -

Identifier Source: org_study_id