NCT04606121

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

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

June 11, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
Last Updated

October 28, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

October 23, 2020

Last Update Submit

October 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T)

    2020

  • scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF)

    2020

Interventions

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei city hospital

Taipei, 10845, Taiwan

Location

Related Publications (1)

  • Wu HA, Chen CH, Hsieh MH, Wu YC, Chiu JP, Huang CJ, Hsu CH. The Benefit of Enhanced Daycare of Traditional Chinese Medicine for Cancer Treatment Related Adverse Events: A Retrospective Study of Medical Records. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211025634. doi: 10.1177/15347354211025634.

MeSH Terms

Interventions

MassageTai Ji

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body TherapiesExercise Movement Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 28, 2020

Study Start

June 11, 2020

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

October 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations