Clinical trial · Observational
Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
- 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 advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life. This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire.
- timeFrame
- Up to 6 months after the end of the physical activity program
- description
- Mean differences on the questionnaire will be evaluated. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item validated tool used to assess the physical, psychological, and social functions of cancer patients. Higher scores on functional scales and the global health status represent a higher/better level of functioning, while higher scores on symptom scales represent a higher level of symptomatology.
Secondary outcomes (8)
- measure
- Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form)
- timeFrame
- Up to 6 months after the end of the physical activity program
- description
- Pain intensity will be assessed using the Brief Pain Inventory (BPI) Severity score, rated on an 11-point Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates greater pain intensity.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy * Female patients ≥18 years of age * Written informed consent must be obtained before any study-related assessment is performed * Participation to the Medicina and Sport physical activity program organized by Andos Pordenone Exclusion Criteria: * Patients with early hormone receptor negative breast cancer * Patients with early hormone receptor positive breast cancer receiving chemotherapy * Patients with advanced/metastatic breast cancer. * Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias). * Patients with history of vertebral and/or femoral fractures * Patients with CVDs not optimally controlled by medical therapy
References
Publications (0)
Data not yet available