Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue

Cancer-related Fatigue Clinical Trial

Official title:

Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428527
• Other study ID #: CRF-NHI01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

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