Colon CancerNCT02512263
Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients
A study testing Home-based training program in people with Colon Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Home-based training program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colon cancer patients treated by chemotherapy adjuvant
Who cannot join
- Patients who have metastasis
- Patients hospitalized during the experimentation
- Patients who have major orthopedic or neurologic problems
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels
Sophie DEBOUCHE, 02 764 16 33, sophie.debouche@gmail.com
Louise CASTAGNE, louise.castagne@student.uclouvain.be
About this study
Official title: Assessment of Adherence and Efficiency of a Home-based Training Program on the Muscular Strength, the Endurance and the Quality of Life for Colon Cancer Patients Treated by Chemotherapy
The purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy.
Read the detailed description
It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.
- Conditions
- Colon Cancer
- Being tested
- Home-based training program
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based training programProcedure or surgery
A home-based training program of 8 exercises to do 5 times a week during 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | They will have to do all the tests and to follow the home-based training program during 9 weeks. Receives: Procedure: Home-based training program |
| control group | No intervention | They will have to do all the tests but not to follow the home-based training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength measured by Microfet
Measured: 15 minutes
Secondary outcomes (6)
Quality of life measured by questionnaire
Measured: 3 minutes
Fatigue measured by questionnaire
Measured: 3 minutes
Physical activity measured by questionnaire
Measured: 3 minutes
Anxiety measured by questionnaire
Measured: 3 minutes
Exercise tolerance measured by Six minute walking test
Measured: 6 minutes
Depression measured by questionnaire
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512263
- Sponsor's protocol ID
- HBTPCoCa
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adherence and Efficiency of a Home-based Training Program on the Muscular Strength, the Endurance and the Quality of Life for Colon Cancer Patients Treated by Chemotherapy
- ClinicalTrials.gov ID
- NCT02512263
- Acronym / sponsor ID
- HBTPCoCa
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 30 Jul 2015 (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 purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy.
Detailed description
It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Home-based training programThey will have to do all the tests and to follow the home-based training program during 9 weeks. |
| control group | No intervention | –They will have to do all the tests but not to follow the home-based training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colon cancer patients treated by chemotherapy adjuvant
Key exclusion criteria (3 listed)
- Patients who have metastasis
- Patients hospitalized during the experimentation
- Patients who have major orthopedic or neurologic problems
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 |
|---|---|---|
| Home-based training programA home-based training program of 8 exercises to do 5 times a week during 9 weeks | Procedure or surgery | Intervention group |
Primary outcome
Muscular strength measured by Microfet
Time frame: 15 minutes
6 secondary outcomes
Quality of life measured by questionnaire
Time frame: 3 minutes
Fatigue measured by questionnaire
Time frame: 3 minutes
Physical activity measured by questionnaire
Time frame: 3 minutes
Anxiety measured by questionnaire
Time frame: 3 minutes
Exercise tolerance measured by Six minute walking test
Time frame: 6 minutes
Depression measured by questionnaire
Time frame: 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based training program in people with Colon Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 30 Jul 2015. 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 Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength measured by Microfet (time frame: 15 minutes). 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 30 Jul 2015.