The Value of Geriatric Assessments in Older Patients With Breast Cancer

NCT03640117 | Unknown

• 1 other identifier: CGAprediting
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy. 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.

Conditions

Aging; Breast Cancer; Chemotherapeutic Toxicity; Survival

Keywords

aging; geriatric assessment; chemotherapy toxicity; overall survival

Outcome Measures

Primary Outcomes (1)

• evaluation of chemotherapy side effects using WHO criteria

  evaluation of chemotherapy side effects using WHO criteria after first circle of chemotherapy and the end of all the chemotherapy.The most serious one from the two evaluation will be used for data analysis to study the relationship between geriatric assessment and chemotherapy toxicity.

  two evaluations completed up to 6 months

Secondary Outcomes (1)

• overall-survival

  5 years

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this prospective cohort study, patients aged 70 years and older with breast cancer, completed geriatric assessment questionnaire prior to therapy. For patients accepted chemotherapy, toxicity after chemotherapy were recorded using WHO criteria.

You may qualify if:

• Confirmed by pathology for breast cancer
• Patients aged 70 years and older

You may not qualify if:

• Patients with severe mental decline who cannot cooperate with the questionnaire

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• shu wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan peng

CONTACT

+8613671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 21, 2018
• Study Start: April 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2025
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

CN (1)