Breast Cancer FemalesNCT07159321
Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma
An observational study of Breast Cancer Females and Frailty, run by Ain Shams University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer Females, Frailty
- What is being tested?
- Comprehensive geriatric assessment, European Organization for Research and Treatment-Quality of life questionnaire and Clinical Frailty Scale
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: older females; 60 years old or older, diagnosed with breast cancer before receiving chemotherapy will be recruited from the clinical oncology department, Ain Shams university hospitals.
Who may be able to join
- Females aged 60 years and older
- Newly diagnosed with pathologically proven breast invasive ductal or lobular carcinoma
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Breast Cancer Females, Frailty
- Being tested
- Comprehensive geriatric assessment, European Organization for Research and Treatment-Quality of life questionnaire, Clinical Frailty Scale
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive geriatric assessmentOther
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 loss, mobility, illness, neuropsychological issues, BMI) scored 0-14, classifying patients as well-nourished (≥12), at risk (8-11), or malnourished (0-7; Rubenstein et al., 2001). Cognition will be assessed using the Saint Louis University Mental Status (SLUMS) exam (Arabic version; Abdelrahamn et al., 2014), a 30-point test evaluating calculation, orientation, memory, fluency, and visuospatial function, with dementia thresholds at <20 (<12 years education) or <21 (≥12 years; Tariq et al., 2006).
European Organization for Research and Treatment-Quality of life questionnaireOther
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) to Very much (4).
EORTC-BR23 consists of 23 items which measure two main scales "Functional Scale (8 items) and "Symptoms scales (15 items). Items measured using 4-point Likert Scale ranging from Not at all (1) to Very much (4).
Clinical Frailty ScaleOther
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 provides a practical and reliable measure of frailty in geriatric populations and has demonstrated strong predictive validity for adverse health outcomes including hospitalization, institutionalization, and mortality.
| Study group | Role | What they receive |
|---|---|---|
| Females aged 60 years and older, who are newly diagnosed with pathologically proven breast inva | Not described Receives: Other: Comprehensive geriatric assessment; Other: European Organization for Research and Treatment-Quality of life questionnaire; Other: Clinical Frailty Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and 23.
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.
Measured: 6 months
Secondary outcomes (1)
change in Frailty status as assessed by clinical frailty scale
Frailty assessed via Clinical Frailty Scale (CFS) at baseline and 6 months. The Clinical Frailty Scale (CFS) is a 9-point scale ranging from 1 (very fit) to 9 (terminally ill). Higher scores reflect increasing levels of frailty and are associated with poorer outcomes, while lower scores indicate better physical reserve and functional status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorouq Alaaeldin Abdelaziz Elsayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159321
- Sponsor's protocol ID
- palliative 2025-6
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma
- ClinicalTrials.gov ID
- NCT07159321
- Acronym / sponsor ID
- palliative 2025-6
- Conditions
- Breast Cancer Females, Frailty
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females aged 60 years and older, who are newly diagnosed with pathologically proven breast inva | – | Other: Comprehensive geriatric assessment, Other: European Organization for Research and Treatment-Quality of life questionnaire, Other: Clinical Frailty Scale |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- older females; 60 years old or older, diagnosed with breast cancer before receiving chemotherapy will be recruited from the clinical oncology department, Ain Shams university hospitals.
Key inclusion criteria (2 listed)
- Females aged 60 years and older
- Newly diagnosed with pathologically proven breast invasive ductal or lobular carcinoma
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive geriatric assessmentFunctional 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 loss, mobility, illness, neuropsychological issues, BMI) scored 0-14, classifying patients as well-nourished (≥12), at risk (8-11), or malnourished (0-7; Rubenstein et al., 2001). Cognition will be assessed using the Saint Louis University Mental Status (SLUMS) exam (Arabic version; Abdelrahamn et al., 2014), a 30-point test evaluating calculation, orientation, memory, fluency, and visuospatial function, with dementia thresholds at <20 (<12 years education) or <21 (≥12 years; Tariq et al., 2006). | Other | Females aged 60 years and older, who are newly diagnosed with pathologically proven breast inva |
| European Organization for Research and Treatment-Quality of life questionnaireQuality 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) to Very much (4). EORTC-BR23 consists of 23 items which measure two main scales "Functional Scale (8 items) and "Symptoms scales (15 items). Items measured using 4-point Likert Scale ranging from Not at all (1) to Very much (4). | Other | Females aged 60 years and older, who are newly diagnosed with pathologically proven breast inva |
| Clinical Frailty ScaleFrailty 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 provides a practical and reliable measure of frailty in geriatric populations and has demonstrated strong predictive validity for adverse health outcomes including hospitalization, institutionalization, and mortality. | Other | Females aged 60 years and older, who are newly diagnosed with pathologically proven breast inva |
Primary outcome
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
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.
1 secondary outcome
change in Frailty status as assessed by clinical frailty scale
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Females and Frailty, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doha Rasheedy, MD (+201001193544, doharasheedy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.