Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

November 12, 2012 updated by: National Taiwan University Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • KPS < 60
  • Stage 4
  • Bone meta

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four-year study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201208026RIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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