The Value of Geriatric Assessments in Older Patients With Breast Cancer
NCT ID: NCT03640117
Last Updated: 2019-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-04-01
2025-05-01
Brief Summary
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Investigators' purpose was to determine whether geriatric assessments are associated with completion of a chemotherapy course, grade III/IV toxicity or survival in older adults with breast cancer in older patients.
Investigators want to prospectively enroll breast cancer patients with age ≥70 years. By recording the pre-treatment baseline laboratory tests and geriatric assessments, through questionnaires, including Karnofsky performance status(KPS), Eastern Cooperative Oncology Group(ECOG), Mini Nutritional Assessment(MNA), Activity of daily living(ADL), Instrumental activities of daily living(IADL), Mini-Mental State Examination(MMSE), Geriatric Depression Scale(GDS), G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
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Detailed Description
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Investigators' purpose was to determine whether geriatric assessments are associated with completion of a grade III/IV toxicity or survival in older adults with breast cancer in older patients. A predictive model that incorporates geriatric and oncologic correlates of vulnerability to chemotherapy toxicity in older adults could help both the healthcare provider and the patient weigh the benefits and risks of chemotherapy treatment and could serve as a platform to test interventions to decrease the risk of chemotherapy toxicity.
Investigators enroll the breast cancer patients ≥70y，the general data such as age, BMI, hemoglobin, white blood cells, creatinine, albumin, lactate dehydrogenase, blood pressure (diastolic blood pressure) were recorded; comorbidity scores using Charlson's Co-morbidity index（CCI） scores; a wide variety of comprehensive assessment scales for the elderly, after searching previous research and considering the operability of the actual data collected, the KPS, ECOG, MNA, ADL, IADL, MMSE, GDS, G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg assessments were included. The treatment for these participants were decided by their own doctors. The participants who underwent chemotherapy were recorded for their chemotherapy regimen and dosage, and the side effects of chemotherapy were evaluated at the first cycle and after the end of the drug. The surgical methods, pathology after operation, radiotherapy and endocrine therapy also recorded. Long-term follow-up, record the participant's recurrence and recurrence time, cause of death and time. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients aged 70 years and older
Exclusion Criteria
70 Years
FEMALE
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Principal Investigators
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shu wang
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking university people's hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CGAprediting
Identifier Type: -
Identifier Source: org_study_id
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