Pedometer Intervention and Health Effects for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Pedometer intervention
* Behavioral: Pedometer + hospital based intervention
* Device: Omron Walking Style pro. 20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Myocardial infarction within the past six months Symptomatic heart failure Known angina pectoris Contraindication for moderate to strenuous physical activity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pedometer intervention<br>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. | Behavioral: Pedometer intervention<br>* 12 weeks physical activity intervention (supervised/non-supervised)<br>Device: Omron Walking Style pro. 20<br> <br> * Other names: Pedometer;|
| Active Comparator: Pedometer + hospital based intervention<br>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. | Behavioral: Pedometer + hospital based intervention<br>* 12 weeks physical activity intervention (supervised/non-supervised)<br>Device: Omron Walking Style pro. 20<br> <br> * Other names: Pedometer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen uptake - ( VO2 peak) | Assessed with objective physiological test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | From baseline to 39 weeks | 
| Anxiety and Depression | Assessed by The Hospital Anxiety and Depression Scale | From baseline to 39 weeks | 
| Lifestyle factors | Assessed by smoking cessation, alcohol, diet | From baseline to 39 weeks | 
| Physical activity level | Assessed by the International Physical Activity Questionnaire | From baseline to 39 weeks | 
| Dual Energy X-ray Absorptiometry scan | Assessed by dual energy x-ray absorptiometry. | From baseline to 39 weeks | 
| Blood cholesterols | Assessed by blood samples | From baseline to 39 weeks | 
| Blood pressure / pulse | Assessed by Heart Rate Monitor during the hospital-based intervention | From 6 to 12 weeks | 
| Pedometer Step Count | Assessed by Omron Walking Style pro. 20 with electronic data transmission | From baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Undergoing chemotherapy, Exercise intervention, Health counselling, Symptom management