NCT05428527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.3 years

First QC Date

June 13, 2022

Last Update Submit

July 2, 2024

Conditions

Keywords

Cancer-related Fatiguebreast cancer

Outcome Measures

Primary Outcomes (1)

  • Fatigue Improvement

    through study completion, an average of 4 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Breast cancer patients with Cancer-related fatigue treatment

Breast cancer patients who approved to use NHI to pay for Cancer-related fatigue treatment drug

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

E-Da Cancer Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Taipei Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Oncology

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 23, 2022

Study Start

September 8, 2021

Primary Completion

December 28, 2023

Study Completion

December 31, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations