NCT02243163

Brief Summary

The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Female Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Improve personal health and life quality

    Health and life quality will assessed by modified fatigue inventory and EORTC QLQ-C30 (version 3) at three different times: (1)baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.

    Change from baseline in personal health and life quality at 6 months.

Secondary Outcomes (1)

  • Immune modulation

    Change from baseline in human immunity at 3 months.

Study Arms (1)

Yoga exercise

EXPERIMENTAL

Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.

Behavioral: Yoga exercise

Interventions

Yoga exerciseBEHAVIORAL

Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.

Yoga exercise

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to attend yoga program weekly, and fill out inform consent.
  • Patients with breast cancer after complete treatment for at least 3 months (including surgery and / or radiotherapy and/or chemotherapy).

You may not qualify if:

  • male
  • overweight
  • unable to do yoga exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

Study Officials

  • Shu-Hui Yeh, PhD

    Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology

    STUDY CHAIR

  • Kuender D. Yang, PhD

    Chang Bing Show Chwan Memorial Hospital

    STUDY DIRECTOR

  • Shin-Mae Wang, MD.

    Show Chwan Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin-Mae Wang, MD.

CONTACT

wangznmg@gmail.com

Shu-Hui Yeh Yeh, PhD

CONTACT

yehshuhui@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Professor

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 17, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

TW(1)