Clinical trial · Interventional
An Interactive Empowerment Tool for Breast Cancer Patients
Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
NCT02312700CI-TRIAL-00016291unknownN/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)
The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.
Conditions
Conditions (2)
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 |
| Empowerment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interactive empowerment tool | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interactive empowerment (IEm) group
- description
- Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician
- interventionNames
- Behavioral: Interactive empowerment tool
- type
- SHAM_COMPARATOR
- label
- Control
- description
- Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician
- interventionNames
- Behavioral: Interactive empowerment tool
Primary outcomes (1)
- measure
- Improvements in the Patient Empowerment Score
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient is aged 18 to 74 years at randomisation. 2. The patient has been diagnosed as having a primary breast cancer requiring a radical surgery 3. The patient is able to understand the Informed Consent Form, and understand study procedures. 4. The patient has signed the Informed Consent Form. Exclusion Criteria: 1. The patient has a recurrent breast cancer diagnosis 2. The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire 3. Inability to freely consent to take part in the study 4. Inability to understand the study materials. 5. Current participation in another clinical trial relating to the breast cancer treatment 6. Any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
References
Publications (1)
- BACKGROUNDKondylakis H, Kazantzaki E, Koumakis L, Genitsaridi I, Marias K, Gorini A, Mazzocco K, Pravettoni G, Burke D, McVie G, Tsiknakis M. Development of interactive empowerment services in support of personalised medicine. Ecancermedicalscience. 2014 Feb 11;8:400. doi: 10.3332/ecancer.2014.400. eCollection 2014. PMID 24567757