The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records

October 27, 2020 updated by: Taipei City Hospital
We collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

using TCM method as Complementary and Alternative Medicine is worldwide. we collected medical records that using TCM methods for adverse event from cancer therapies. we used CTCAE BFI-T and WHOQOF-BREF to evaluate the benefit.

Study Type

Observational

Enrollment (Actual)

401

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10845
        • Taipei City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cancer patients who needed to accept surgery, or chemotherapy, or radiotherapy, or other conventional cancer therapy

Description

Inclusion Criteria:

- The medical records since June 2017 to December 2019 needed to meet the following criterial: (1)age>20 years old, (2)diagnosis meet ICD10:C00.0-C97 (3) needed to do Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE), scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) and scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF), and those scales needed to be done pretest when patient came to the clinics and posttest when case end.

Exclusion Criteria:

- The subjects will be excluded if they do not complete pretest and posttest of the following scales:(1) Taiwan brief version scale of CTCAE, (2) BFI-T scale (3) WHOQOL-BREF scale

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE)
Time Frame: 2020
for chemotherapy related adverse effects in Taiwan
2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T)
Time Frame: 2020
evaluate the level of fatique
2020
scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF)
Time Frame: 2020
evaluate QOL
2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

June 11, 2020

Study Completion (Actual)

June 11, 2020

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TCHIRB-10905008-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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