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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05428527

Enrollment

261

Registered

2022-06-23

Start date

2021-09-08

Completion date

2023-12-31

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related Fatigue

Keywords

Cancer-related Fatigue, breast cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame
Fatigue Improvement	through study completion, an average of 4 months

Secondary

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

Countries

Taiwan

Outcome results