Developing Objective Fatigue Indicators in Colorectal Can... | NCT01700283

Studies
Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

NCT01700283

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 14, 2012Estimated

Enrollment

306Estimated

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

exercise education and walking program

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Oct 2, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise education and walking program	Experimental		Behavioral: exercise education and walking program
maintain their daily activity	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise education and walking program	Behavioral	12-week moderate intensity walking program	exercise education and walking program

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shiow-Ching Shun, PHD	Contact	886-2-23123456	88439	scshun@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Shiow-Ching Shun, PhD	National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided