Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma

Обзор

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.

Вмешательства

• Другое 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
• Другое 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)
• Другое 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

Первичные конечные точки

• Change in the Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and 23. [Срок оценки: 6 months]

Вторичные конечные точки (1)

• change in Frailty status as assessed by clinical frailty scale [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Females aged 60 years and older
• Newly diagnosed with pathologically proven breast invasive ductal or lobular carcinoma

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07159321 · palliative 2025-6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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