Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive geriatric assessment, European Organization for Research and Treatment-Quality of life questionnaire, Clinical Frailty Scale.
- Who it may be relevant to
- Registry conditions: Breast Cancer Females, Frailty. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Comprehensive geriatric assessment
Functional status will be evaluated using Activities of Daily Living (ADL) (assessing bathing, dressing, toileting, transferring, eating, and continence; Katz, 1970) and Instrumental ADL (IADL) (assessing shopping, cooking, medication management, phone use, housework, laundry, transportation, and finances; Lawton \& Brody, 1969). Nutritional status will be measured via the Mini-Nutritional Assessment-Short Form (MNA-SF) (Arabic version; Abd-Al-Atty et al., 2012), a 6-item tool (appetite, weight - Other European Organization for Research and Treatment-Quality of life questionnaire
Quality of life assessment by European Organization for Research and Treatment-Quality of life questionnaire and breast cancer-specific module (EORTC QLQ-C30)and QLQ-BR23) EORTC QLQ-C30 is a validated tool designed to measure cancer patients' physical, psychological and social functions. It consists of 30 items measuring Global Health status (2 items), Functional scales (15 items) and Symptoms scales/items (13 items). Items were measured using a 4-point Likert Scale ranging from Not at all (1) - Other Clinical Frailty Scale
Frailty will be assessed using the Clinical Frailty Scale (CFS), a validated and widely used tool developed by (Rockwood et al., 2005). The CFS is a 9-point ordinal scale that categorizes older adults based on their level of physical fitness, functional independence, and comorbidities, ranging from 1 indicate very fit to 9 indicate terminally ill. Participants were evaluated by trained clinicians based on their clinical judgment, incorporating information from patient interviews. The scale provi
Primary outcome measures
- Change in the Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and 23. [Time frame: 6 months]
Secondary outcome measures (1)
- change in Frailty status as assessed by clinical frailty scale [Time frame: 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07159321 · palliative 2025-6