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

Completed

• Conditions: Cancer-related Fatigue

• Registration Number: NCT05428527
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-08
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Primary Completion: 2023-12-28
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue Improvement	through study completion, an average of 4 months

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Chang Gung Memorial Hospital, Keelung; 🇨🇳 Keelung, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan

E-Da Cancer Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan