Clinical trial · Observational
Evaluating and Following Breast Cancer Patients in a Better Way
Evaluating, Following, and Supporting Breast Cancer Patients in a Better Way
- 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 current observational study aims at analysing current semiology on breast cancer patients aiming at noting indicators and signs with significant relationship with the disease outcomes. To reach the primary objective, of identifying most prominent indicators and signs, a study group of at least 100 female patients with breast cancer diagnosis will be recruited to participate voluntarily. The study group will include at least 20 patients with metastatic cancer and 30 patients with indication to adjuvant chemotherapy. Their physical activity habits and lifestyle will be noted. The observational study will consist in the periodic registration of the overall physical and psychological condition. The variables and tests below will be measured and registered, periodically: * periodical assessment of the quality of life * periodical assessment of the fitness status of the subjects * assessment of changes in bone density/progression of osteoporosis * assessment of changes in cognitive function * assessment of sleep disorders The collected results will be statistically analysed, in order to: * Identify variables that are statistically significantly different from expected values * quantify statistically significant differences, whenever possible The results will be used to better describe the breast cancer population
Conditions
Conditions (1)
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinical and physical assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer new diagnosis
- description
- group will include volunteer women, diagnosed with breast cancer, in any stage, aged 18y or more; at least 100 patients will be recruited in medical oncology appointments; all subjects should be periodically submitted to non-invasive evaluation tests - that is, clinical test/clinical and physical assessment to collect information on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life
- interventionNames
- Diagnostic Test: clinical and physical assessment
Primary outcomes (2)
- measure
- Global medical assessment
- timeFrame
- 1st month at enrolment
- description
- during the first medical appointment general health status and cancer staging will be noted for each participant; participants will be asked about their lifestyle, namely to register those with a sedentary lifestyle vs those enrolled in any regular physical activity
- measure
- Assessment of changes in the cardiac function/fitness status of the subjects
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * women * age \> 18y * diagnosed with breast cancer Exclusion Criteria: * men * informed consent
References
Publications (0)
Data not yet available