Clinical trial · Observational
Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma
- 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)
This study addresses a critical gap in the care of older women with breast cancer, a population often underrepresented in clinical research despite their increased vulnerability to treatment-related complications. By examining the relationship between frailty and health-related quality of life (QOL), the study aims to provide evidence-based insights into how geriatric assessments can guide personalized treatment decisions, ensuring that therapeutic benefits outweigh risks. Given that older adults prioritize QOL over survival gains, understanding the impact of frailty on their well-being can help clinicians optimize care plans, reduce adverse outcomes, and improve overall patient-centered outcomes. The findings may also inform the integration of routine geriatric assessments in oncology practice, ultimately enhancing the management of older cancer patients in resource-limited settings like Egypt.
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 Females | — | UNRESOLVED | — |
| Frailty | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Frailty Scale | Other | — | UNRESOLVED |
| Comprehensive geriatric assessment | Other | — | UNRESOLVED |
| European Organization for Research and Treatment-Quality of life questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Females aged 60 years and older, who are newly diagnosed with pathologically proven breast inva
- interventionNames
- Other: Comprehensive geriatric assessment
- Other: European Organization for Research and Treatment-Quality of life questionnaire
- Other: Clinical Frailty Scale
Primary outcomes (1)
- measure
- Change in the Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and 23.
- timeFrame
- 6 months
- description
- Health-related quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the Breast Cancer-Specific Module. Both instruments generate scores ranging from 0 to 100. For functional domains and global health status, higher scores indicate better quality of life, whereas for symptom domains, higher scores indicate more severe symptoms and worse outcomes at baseline and 6 months.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged 60 years and older * Newly diagnosed with pathologically proven breast invasive ductal or lobular carcinoma Exclusion Criteria: * History of cognitive impairment or psychiatric disorders * Delirium during assessment using the Confusion Assessment Method (CAM test) * Initiation of chemotherapy before the baseline assessment * Severe hearing or visual impairment preventing completion of assessment * Other malignancies (second primary) * Other breast malignancies (e.g., sarcoma) * End-organ failure (e.g., renal failure, liver cell failure)
References
Publications (0)
Data not yet available