Cancer-related FatigueNCT05428527
Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue
An observational study of Cancer-related Fatigue, run by National Defense Medical Center, Taiwan at 9 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer-related Fatigue
- How many people
- 261 participants
- Where
- 9 sitesTaiwan
- Study dates
- 8 Sep 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug
Who may be able to join
- breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug
Who cannot join
- N/A
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
E-Da Cancer Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital, Keelung
Keelung
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Mackay Memorial Hospital
Taipei
Taipei Chang Gung Memorial Hospital
Taipei
Tri-Service General Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan
About this study
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.
Read the 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.
- Conditions
- Cancer-related Fatigue
- Keywords
- Cancer-related Fatigue, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with Cancer-related fatigue treatment | Breast cancer patients who approved to use NHI to pay for Cancer-related fatigue treatment drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Improvement
Measured: through study completion, an average of 4 months
Secondary outcomes (8)
The Level of Fatigue Clinical Global Impression-Improvement
Measured: through study completion, an average of 4 months
Physician Satisfaction Degree of Overall Clinical Evaluation
Measured: 1 time, average of 4 months after baseline (at the end of study)
Patient Expectation Rating of Continuous Cancer-Related Fatigue Treatment
Measured: 1 time, average of 4 months after baseline (at the end of study)
ECOG Change
Measured: through study completion, an average of 4 months
Weight Change
Measured: through study completion, an average of 4 months
Hematological Lab Data Change
Measured: through study completion, an average of 4 months
The Incidence of Cancer Treatent Delay
Measured: through study completion, an average of 4 months
The Incidence of Cancer Treatent Dose Modification
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start8 Sep 2021
- Primary completion28 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taichung Veterans General Hospital, E-Da Cancer Hospital, Chang Gung Memorial Hospital, Taipei, Chang Gung Memorial Hospital, Tri-Service General Hospital (TSGH), China Medical University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Mackay Memorial Hospital, Chang Gung Memorial Hospital, Keelung
- Responsible party
- Principal investigator, Ming-Shen Dai, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428527
- Sponsor's protocol ID
- CRF-NHI01
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue
- ClinicalTrials.gov ID
- NCT05428527
- Acronym / sponsor ID
- CRF-NHI01
- Conditions
- Cancer-related Fatigue
- Keywords
- Cancer-related Fatigue, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Taichung Veterans General Hospital, E-Da Cancer Hospital, Chang Gung Memorial Hospital, Taipei, Chang Gung Memorial Hospital, Tri-Service General Hospital (TSGH), China Medical University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Mackay Memorial Hospital, Chang Gung Memorial Hospital, Keelung
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with Cancer-related fatigue treatment | – | –Breast cancer patients who approved to use NHI to pay for Cancer-related fatigue treatment drug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug
Key inclusion criteria (1 listed)
- breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue Improvement
Time frame: through study completion, an average of 4 months
8 secondary outcomes
The Level of Fatigue Clinical Global Impression-Improvement
Time frame: through study completion, an average of 4 months
Physician Satisfaction Degree of Overall Clinical Evaluation
Time frame: 1 time, average of 4 months after baseline (at the end of study)
Patient Expectation Rating of Continuous Cancer-Related Fatigue Treatment
Time frame: 1 time, average of 4 months after baseline (at the end of study)
ECOG Change
Time frame: through study completion, an average of 4 months
Weight Change
Time frame: through study completion, an average of 4 months
Hematological Lab Data Change
Time frame: through study completion, an average of 4 months
The Incidence of Cancer Treatent Delay
Time frame: through study completion, an average of 4 months
The Incidence of Cancer Treatent Dose Modification
Time frame: through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer-related Fatigue
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Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
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Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
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RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Fatigue, run by National Defense Medical Center, Taiwan at 9 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Improvement (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.