Colorectal CancerNCT02522520
Pedometer Intervention and Health Effects for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy
A study testing Pedometer intervention, Pedometer + hospital based intervention and Omron Walking Style pro. 20 in people with Colorectal Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Pedometer intervention, Pedometer + hospital based intervention and Omron Walking Style pro. 20
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Sep 2021
- 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
- Diagnosed with colorectal cancer in adjuvant chemotherapy
- Age 18+ years
- WHO performance status of 0 or 1
- Undergone surgery at least 6 weeks ago
- Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.
Who cannot join
- Myocardial infarction within the past six months
- Symptomatic heart failure
- Known angina pectoris
- Contraindication for moderate to strenuous physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial
Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity.
There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy
Read more
The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy.
The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy.
Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week).
Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur.
- Conditions
- Colorectal Cancer
- Being tested
- Pedometer intervention, Pedometer + hospital based intervention, Omron Walking Style pro. 20
- Keywords
- Undergoing chemotherapy, Exercise intervention, Health counselling, Symptom management
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer interventionBehavioural
12 weeks physical activity intervention (supervised/non-supervised)
Pedometer + hospital based interventionBehavioural
12 weeks physical activity intervention (supervised/non-supervised)
Omron Walking Style pro. 20Device
Also called Pedometer
| Study group | Role | What they receive |
|---|---|---|
| Pedometer intervention | Active comparator | Individual progressive pedometer intervention of low to moderate intensity.
Furthermore, the patients receive individual health counseling and symptom management counseling to support behavioral change towards increased physical activity. Receives: Behavioral: Pedometer intervention; Device: Omron Walking Style pro. 20 |
| Pedometer + hospital based intervention | Active comparator | Individual progressive pedometer intervention and 5 sessions supervised interval walking + followed by supervised hospital-based intervention of moderate to high-intensity
Furthermore, the patients receive individual health counseling and symptom management counseling to support behavioral change towards increased physical activity. Receives: Behavioral: Pedometer + hospital based intervention; Device: Omron Walking Style pro. 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake - ( VO2 peak)
Assessed with objective physiological test
Measured: 12 weeks
Secondary outcomes (9)
Health related Quality of Life
Assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, specifically for colon cancer patients
Measured: From baseline to 39 weeks
Symptoms and side-effects
Assessed by MD Andersen symptom questionnaire and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, chemotherapy-induced peripheral neuropathy
Measured: From baseline to 39 weeks
Anxiety and Depression
Assessed by The Hospital Anxiety and Depression Scale
Measured: From baseline to 39 weeks
Lifestyle factors
Assessed by smoking cessation, alcohol, diet
Measured: From baseline to 39 weeks
Physical activity level
Assessed by the International Physical Activity Questionnaire
Measured: From baseline to 39 weeks
Dual Energy X-ray Absorptiometry scan
Assessed by dual energy x-ray absorptiometry.
Measured: From baseline to 39 weeks
Blood cholesterols
Assessed by blood samples
Measured: From baseline to 39 weeks
Blood pressure / pulse
Assessed by Heart Rate Monitor during the hospital-based intervention
Measured: From 6 to 12 weeks
Pedometer Step Count
Assessed by Omron Walking Style pro. 20 with electronic data transmission
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2020
- Study completionSep 2021
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 Copenhagen University Hospital, RigshospitaletThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Novo Nordisk A/S, Danish Cancer Society, TrygFonden, Denmark
- Responsible party
- Principal investigator, Christina Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lis Adamsen, Professor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522520
- Sponsor's protocol ID
- CIRE-15
- Status last verified
- Apr 2023
- First submitted
- 4 Aug 2015
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Presently no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT02522520
- Acronym / sponsor ID
- CIRE-15
- Conditions
- Colorectal Cancer
- Keywords
- Undergoing chemotherapy, Exercise intervention, Health counselling, Symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Novo Nordisk A/S, Danish Cancer Society, TrygFonden, Denmark
- Study start
- Jun 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 13 Aug 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.
Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity.
There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy
The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy.
The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy.
Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week).
Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer intervention | Active comparator | Behavioral: Pedometer intervention, Device: Omron Walking Style pro. 20Individual progressive pedometer intervention of low to moderate intensity. Furthermore, the patients receive individual health counseling and symptom management counseling to support behavioral change towards increased physical activity. |
| Pedometer + hospital based intervention | Active comparator | Behavioral: Pedometer + hospital based intervention, Device: Omron Walking Style pro. 20Individual progressive pedometer intervention and 5 sessions supervised interval walking + followed by supervised hospital-based intervention of moderate to high-intensity Furthermore, the patients receive individual health counseling and symptom management counseling to support behavioral change towards increased physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with colorectal cancer in adjuvant chemotherapy
- Age 18+ years
- WHO performance status of 0 or 1
- Undergone surgery at least 6 weeks ago
- Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.
Key exclusion criteria (4 listed)
- Myocardial infarction within the past six months
- Symptomatic heart failure
- Known angina pectoris
- Contraindication for moderate to strenuous physical activity
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 |
|---|---|---|
| Pedometer intervention12 weeks physical activity intervention (supervised/non-supervised) | Behavioural | Pedometer intervention |
| Pedometer + hospital based intervention12 weeks physical activity intervention (supervised/non-supervised) | Behavioural | Pedometer + hospital based intervention |
| Omron Walking Style pro. 20Also: Pedometer | Device | Pedometer + hospital based intervention, Pedometer intervention |
Primary outcome
Maximum oxygen uptake - ( VO2 peak)
Time frame: 12 weeks
Assessed with objective physiological test
9 secondary outcomes
Health related Quality of Life
Time frame: From baseline to 39 weeks
Symptoms and side-effects
Time frame: From baseline to 39 weeks
Anxiety and Depression
Time frame: From baseline to 39 weeks
Lifestyle factors
Time frame: From baseline to 39 weeks
Physical activity level
Time frame: From baseline to 39 weeks
Dual Energy X-ray Absorptiometry scan
Time frame: From baseline to 39 weeks
Blood cholesterols
Time frame: From baseline to 39 weeks
Blood pressure / pulse
Time frame: From 6 to 12 weeks
Pedometer Step Count
Time frame: From baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No. Presently no plan to make IPD available to other researchers
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Lis Adamsen, Professor study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer intervention, Pedometer + hospital based intervention and Omron Walking Style pro. 20 in people with Colorectal Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Apr 2023. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen uptake - ( VO2 peak) (time frame: 12 weeks). 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 20 Apr 2023.