Clinical trial · Interventional
Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer
Shared Decision Making in Follow-up Imaging Surveillance for Distant Metastasis in Treated Breast Cancer Patients [SMART-FU]: A Prospective, Single-institution, Randomized Pragmatic Trial
NCT04862078CI-TRIAL-00078631SMART-FUunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, clinical impacts of shared decision making between physicians and patients in strategy of surveillance for asymptomatic patients who ended the primary treatments on quality of life would be investigated
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shared decision making | Diagnostic Test | — | UNRESOLVED |
| Usual care | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shared decision making group
- description
- The Study arm - shared decision making when deciding surveillance strategy
- interventionNames
- Diagnostic Test: Shared decision making
- type
- OTHER
- label
- Usual surveillance group
- description
- The control arm - surveillance with usual care
- interventionNames
- Diagnostic Test: Usual care
Primary outcomes (4)
- measure
- Quality of life (QoL), Depression-anxiety scale
- timeFrame
- At the point of enrollment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women between 20-70 years * Invasive unilateral breast carcinoma with histological confirmation * History of invasive breast cancer * TMN stage I-II according to AJCC 7th * Histologically or radiologically no suspicion of distant metastases * Performance status corresponding to ECOG grade 0-2 * No psychological and geographical restriction in follow-up * Written informed consent Exclusion Criteria: * History of any cancer in the previous 5 years * Bilateral breast cancer * Male breast cancer * Patients who are planning for surveillance in other institutions * Unable to understand and fill out questionnaires
References
Publications (0)
Data not yet available
No reference posted for this study.