Colorectal CancerNCT01700283
Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.
A study testing exercise education and walking program in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- exercise education and walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer survivors completed treatment at least 3 months in clinics.
- Aged above 20.
Who cannot join
- KPS < 60
- Stage 4
- Bone meta
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Shiow-Ching Shun, PHD, 886-2-2312-3456 ext. 88439, scshun@ntu.edu.tw
Shiow-Ching Shun, PHD
About this study
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.
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.
- Conditions
- Colorectal Cancer
- Being tested
- exercise education and walking program
- Keywords
- Colorectal Cancer、Fatigue、Muscle strength、Metabolomics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise education and walking programBehavioural
12-week moderate intensity walking program
| Study group | Role | What they receive |
|---|---|---|
| exercise education and walking program | Experimental | Not described Receives: Behavioral: exercise education and walking program |
| maintain their daily activity | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four-year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shiow-Ching Shun, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700283
- Sponsor's protocol ID
- 201208026RIC
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01700283
- Acronym / sponsor ID
- 201208026RIC
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer、Fatigue、Muscle strength、Metabolomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Oct 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise education and walking program | Experimental | Behavioral: exercise education and walking program |
| maintain their daily activity | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Colorectal cancer survivors completed treatment at least 3 months in clinics.
- Aged above 20.
Key exclusion criteria (3 listed)
- KPS < 60
- Stage 4
- Bone meta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise education and walking program12-week moderate intensity walking program | Behavioural | exercise education and walking program |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiow-Ching Shun, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise education and walking program in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiow-Ching Shun, PHD (886-2-23123456 ext. 88439, scshun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012; AzTrials last refreshed its copy on 31 Oct 2026.