Clinical trial NCT05428527: Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue
Official title: Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer-related Fatigue
Keywords: Cancer-related Fatigue
breast cancer
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Taichung Veterans General Hospital
name: E-Da Cancer Hospital
name: Chang Gung Memorial Hospital, Taipei
name: Chang Gung Memorial Hospital
name: Tri-Service General Hospital
name: China Medical University Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Mackay Memorial Hospital
name: Chang Gung Memorial Hospital, Keelung
First posted: 2022-06-23
Enrollment: 261
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Fatigue Improvement
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: The Level of Fatigue Clinical Global Impression-Improvement
timeFrame: through study completion, an average of 4 months
measure: Physician Satisfaction Degree of Overall Clinical Evaluation
timeFrame: 1 time, average of 4 months after baseline (at the end of study)
measure: Patient Expectation Rating of Continuous Cancer-Related Fatigue Treatment
timeFrame: 1 time, average of 4 months after baseline (at the end of study)
measure: ECOG Change
timeFrame: through study completion, an average of 4 months
measure: Weight Change
timeFrame: through study completion, an average of 4 months
measure: Hematological Lab Data Change
timeFrame: through study completion, an average of 4 months
measure: The Incidence of Cancer Treatent Delay
timeFrame: through study completion, an average of 4 months
measure: The Incidence of Cancer Treatent Dose Modification
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da Cancer Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References: