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

Chemotherapy-Induced Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606121
• Other study ID #: TCHIRB-10905008-E
• Status: Completed
• Start date: June 11, 2020
• Est. completion date: June 11, 2020

Study information

• Verified date: July 2020
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Change

Intervention

Combination Product:
• enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine
acupuncture twice in enhanced day care of TCM massage twice in enhanced day care of TCM tai ji quan one time in enhanced day care of TCM TCM herbal powder three times a day

Locations

Country	Name	City	State
Taiwan	Taipei city hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE)	for chemotherapy related adverse effects in Taiwan	2020
Secondary	scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T)	evaluate the level of fatique	2020
Secondary	scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF)	evaluate QOL	2020