Status:

COMPLETED

Rehabilitation After Breast Cancer

Lead Sponsor:

Danish Cancer Society

Collaborating Sponsors:

Rigshospitalet, Denmark

Copenhagen University Hospital at Herlev

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms amon...

Detailed Description

During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter t...

Eligibility Criteria

Inclusion

  • Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score \< 7 on the distress thermometer) will be followed in an observational questionnaire study.

Exclusion

  • no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,

Key Trial Info

Start Date :

August 15 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2021

Estimated Enrollment :

309 Patients enrolled

Trial Details

Trial ID

NCT03254875

Start Date

August 15 2017

End Date

March 31 2021

Last Update

August 27 2021

Active Locations (1)

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1

Rigshospitalet

Copenhagen, Denmark, DK-2100