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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05428527
Other study ID # CRF-NHI01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2021
Est. completion date December 31, 2023

Study information

Verified date March 2023
Source National Defense Medical Center, Taiwan
Contact Hsiao Chien Cheng
Email hcchengstudy@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective study is to collect and analyze the data from medical records within the period that breast cancer patient is receiving NHI-covered CRF treatment. This study will evaluate the clinical use, fatigue improvement, and treatment satisfaction of breast cancer patients with CRF treatment.


Description:

This is a single arm, multicenter, and retrospective study. About 200 breast cancer patients' data from medical records are expected to collect and analyze in this retrospective study. The data collection from medical records of breast cancer patients who approved to use NHI to pay for CRF treatment drug will include the demographic information, disease characteristics and cancer treatment information, fatigue score by visual analog fatigue scale, fatigue clinical global impression, CRF pharmacological treatment record, hematological lab data, ECOG, cancer drug compliance record, overall clinical evaluation after CRF treatment by physicians and patient's expectation to continue CRF treatment etc. Data of three return visits (i.e. at the time of before CRF treatment, after 4 times of CRF treatment and CRF treatment completed) per patient will be collected from medical records to analysis within the period that patient is receiving NHI-covered CRF treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan E-Da Cancer Hospital Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Taipei Chang Gung Memorial Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan

Sponsors (8)

Lead Sponsor Collaborator
National Defense Medical Center, Taiwan China Medical University Hospital, E-Da Cancer Hospital, Taiwan, Kaohsiung Medical University Chung-Ho Memorial Hospital, Linkou Chang Gung Memorial Hospital, Taiwan, Taichung Veterans General Hospital, Taipei Chang Gung Memorial Hospital, Taiwan, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Improvement through study completion, an average of 4 months
Secondary The Level of Fatigue Clinical Global Impression-Improvement through study completion, an average of 4 months
Secondary Physician Satisfaction Degree of Overall Clinical Evaluation 1 time, average of 4 months after baseline (at the end of study)
Secondary Patient Expectation Rating of Continuous Cancer-Related Fatigue Treatment 1 time, average of 4 months after baseline (at the end of study)
Secondary ECOG Change through study completion, an average of 4 months
Secondary Weight Change through study completion, an average of 4 months
Secondary Hematological Lab Data Change through study completion, an average of 4 months
Secondary The Incidence of Cancer Treatent Delay through study completion, an average of 4 months
Secondary The Incidence of Cancer Treatent Dose Modification through study completion, an average of 4 months
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