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Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

This study is currently recruiting participants.
Verified October 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01700283
First received: October 2, 2012
Last updated: November 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Colorectal Cancer
 Behavioral: exercise education and walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

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 [ Time Frame: four-year study ] [ Designated as safety issue: No ]
    Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.


Estimated Enrollment: 306
Study Start Date: October 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise education and walking program Behavioral: exercise education and walking program
12-week moderate intensity walking program
No Intervention: maintain their daily activity

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700283

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

Locations
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
Principal Investigator: Shiow-Ching Shun, PhD National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01700283     History of Changes
Other Study ID Numbers: 201208026RIC
Study First Received: October 2, 2012
Last Updated: November 12, 2012
Health Authority: Taiwan:National Science Council

Keywords provided by National Taiwan University Hospital:
Colorectal Cancer、Fatigue、Muscle strength、Metabolomics

Additional relevant MeSH terms:
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
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013