Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

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: Colorectal Cancer
• Intervention / Treatment: Behavioral: exercise education and walking program

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.	four-year study

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan

Study record dates

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: Colorectal Cancer、Fatigue、Muscle strength、Metabolomics
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Fatigue; Colorectal Neoplasms
• Other Study ID Numbers: 201208026RIC