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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.


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer Patients

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Subscale quality of life of the questionnaire: EORTC QLQ C30

Outcome Description:

Subscale quality of life of the questionnaire: EORTC QLQ C30

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

P. B. Ottevanger, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Nijmegen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

CMO: 2009/293

NCT ID:

NCT01091584

Start Date:

March 2010

Completion Date:

March 2015

Related Keywords:

  • Breast Cancer Patients
  • Breast Neoplasms

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