Trials / Completed
CompletedNCT03254875
Rehabilitation After Breast Cancer
Individually Tailored Rehabilitation After Breast Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 309 (actual)
- Sponsor
- Danish Cancer Society · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
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 the randomized controlled trial (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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Individually tailored nurse navigation | The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs. |
Timeline
- Start date
- 2017-08-15
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2017-08-21
- Last updated
- 2021-08-27
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03254875. Inclusion in this directory is not an endorsement.