Clinical Trial - Breast Cancer

Danish Cancer Society is running a clinical trial to test individually tailored nurse navigation to promote rehabilitation after breast cancer. 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 among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).

The intervention is individually tailored nurse navigation.

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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 the RCT and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
Masking: Single (Outcomes Assessor)
Masking Description: Intervention status will be blinded in analyses.
Primary Purpose: Supportive Care
Official Title: Individually Tailored Rehabilitation After Breast Cancer
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

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