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NCT Number: NCT05428527

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

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.

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Key information

Conditions

Cancer-related Fatigue Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

E-Da Cancer Hospital, Kaohsiung City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Fatigue Improvement

    Time frame: through study completion, an average of 4 months

Secondary outcomes

  1. The Level of Fatigue Clinical Global Impression-Improvement

    Time frame: through study completion, an average of 4 months

  2. Physician Satisfaction Degree of Overall Clinical Evaluation

    Time frame: 1 time, average of 4 months after baseline (at the end of study)

  3. Patient Expectation Rating of Continuous Cancer-Related Fatigue Treatment

    Time frame: 1 time, average of 4 months after baseline (at the end of study)

  4. ECOG Change

    Time frame: through study completion, an average of 4 months

  5. Weight Change

    Time frame: through study completion, an average of 4 months

  6. Hematological Lab Data Change

    Time frame: through study completion, an average of 4 months

  7. The Incidence of Cancer Treatent Delay

    Time frame: through study completion, an average of 4 months

  8. The Incidence of Cancer Treatent Dose Modification

    Time frame: through study completion, an average of 4 months

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Collaborators

  • Chang Gung Memorial Hospital
  • Chang Gung Memorial Hospital, Keelung
  • Chang Gung Memorial Hospital, Taipei
  • China Medical University Hospital
  • E-Da Cancer Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Mackay Memorial Hospital
  • Taichung Veterans General Hospital
  • Tri-Service General Hospital (TSGH)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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