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Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise education and walking program
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Colorectal Cancer、Fatigue、Muscle strength、Metabolomics

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Colorectal cancer survivors completed treatment at least 3 months in clinics.
  • Aged above 20.

Exclusion Criteria:

  • KPS < 60
  • Stage 4
  • Bone meta

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise education and walking program

maintain their daily activity

Arm Description

Outcomes

Primary Outcome Measures

Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors
Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2012
Last Updated
November 12, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01700283
Brief Title
Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.
Official Title
Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aims of this four-year study are to Explore exercise behavior, exercise barriers, and identify the significant factors for exercise behavior in colorectal cancer survivors. Explore the relationships among fatigue, muscle strength, and metabolomics and further examine the possible biomarkers from muscle strength and metabolomics for fatigue. Develop a clinical guidelines of home-based fatigue management and exercise program and test its effect on decreasing fatigue for patients with colorectal cancer after surgery in Taiwan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer、Fatigue、Muscle strength、Metabolomics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise education and walking program
Arm Type
Experimental
Arm Title
maintain their daily activity
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
exercise education and walking program
Intervention Description
12-week moderate intensity walking program
Primary Outcome Measure Information:
Title
Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors
Description
Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.
Time Frame
four-year study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colorectal cancer survivors completed treatment at least 3 months in clinics. Aged above 20. Exclusion Criteria: KPS < 60 Stage 4 Bone meta
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiow-Ching Shun, PHD
Phone
886-2-23123456
Ext
88439
Email
scshun@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Phone
886-2-2312-3456
Ext
88439
Email
scshun@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD

12. IPD Sharing Statement

Learn more about this trial

Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

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