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Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

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ClinicalTrials.gov Identifier: NCT01700283
Recruitment Status : Unknown
Verified October 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 4, 2012
Last Update Posted : November 14, 2012
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:

The aims of this four-year study are to

  1. Explore exercise behavior, exercise barriers, and identify the significant factors for exercise behavior in colorectal cancer survivors.
  2. Explore the relationships among fatigue, muscle strength, and metabolomics and further examine the possible biomarkers from muscle strength and metabolomics for fatigue.
  3. 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: exercise education and walking program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : October 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: exercise education and walking program Behavioral: exercise education and walking program
12-week moderate intensity walking program
No Intervention: maintain their daily activity


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: four-year study ]
    Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700283


Contacts
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Contact: Shiow-Ching Shun, PHD 886-2-23123456 ext 88439 scshun@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, PHD    886-2-2312-3456 ext 88439    scshun@ntu.edu.tw   
Principal Investigator: Shiow-Ching Shun, PHD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: Shiow-Ching Shun, PhD National Taiwan University
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01700283    
Other Study ID Numbers: 201208026RIC
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: October 2012
Keywords provided by National Taiwan University Hospital:
Colorectal Cancer、Fatigue、Muscle strength、Metabolomics
Additional relevant MeSH terms:
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Colorectal Neoplasms
Fatigue
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases