Nurse Intervention Project

NCT01091584 | Completed

• 1 other identifier: CMO: 2009/293
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Other subscales

  After each treatment completion, during follow up; first year every 3 months, second year every 6 months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

usual care

Interventions

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

intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven malignancy of the breast
• Curative treatment
• Dominated the dutch language
• Age \> 18 year

You may not qualify if:

• Previously treated for a malignancy
• Psychiatric problems that adherence this study

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Centre Nijmegen

Nijmegen, 6500, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 27455960 DERIVED

Study Officials

• P. B. Ottevanger, Dr

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 24, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-11

Locations

NL (1)