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

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ClinicalTrials.gov Identifier: NCT02522520
Recruitment Status : Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Copenhagen University Hospital at Herlev
Novo Nordisk A/S
Danish Cancer Society
TrygFonden, Denmark
Information provided by (Responsible Party):
Christina Andersen, Rigshospitalet, Denmark

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Pedometer intervention Behavioral: Pedometer + hospital based intervention Device: Omron Walking Style pro. 20 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Primary outcome (VO2 peak) Physiological tests assessors blinded
Primary Purpose: Other
Official Title: Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pedometer intervention

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
12 weeks physical activity intervention (supervised/non-supervised)

Device: Omron Walking Style pro. 20
Other Name: Pedometer

Active Comparator: Pedometer + hospital based intervention

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
12 weeks physical activity intervention (supervised/non-supervised)

Device: Omron Walking Style pro. 20
Other Name: Pedometer




Primary Outcome Measures :
  1. Maximum oxygen uptake - ( VO2 peak) [ Time Frame: 12 weeks ]
    Assessed with objective physiological test


Secondary Outcome Measures :
  1. Health related Quality of Life [ Time Frame: From baseline to 39 weeks ]
    Assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, specifically for colon cancer patients

  2. Symptoms and side-effects [ Time Frame: From baseline to 39 weeks ]
    Assessed by MD Andersen symptom questionnaire and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, chemotherapy-induced peripheral neuropathy

  3. Anxiety and Depression [ Time Frame: From baseline to 39 weeks ]
    Assessed by The Hospital Anxiety and Depression Scale

  4. Lifestyle factors [ Time Frame: From baseline to 39 weeks ]
    Assessed by smoking cessation, alcohol, diet

  5. Physical activity level [ Time Frame: From baseline to 39 weeks ]
    Assessed by the International Physical Activity Questionnaire

  6. Dual Energy X-ray Absorptiometry scan [ Time Frame: From baseline to 39 weeks ]
    Assessed by dual energy x-ray absorptiometry.

  7. Blood cholesterols [ Time Frame: From baseline to 39 weeks ]
    Assessed by blood samples

  8. Blood pressure / pulse [ Time Frame: From 6 to 12 weeks ]
    Assessed by Heart Rate Monitor during the hospital-based intervention

  9. Pedometer Step Count [ Time Frame: From baseline to 12 weeks ]
    Assessed by Omron Walking Style pro. 20 with electronic data transmission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522520


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Novo Nordisk A/S
Danish Cancer Society
TrygFonden, Denmark
Investigators
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Study Director: Lis Adamsen, Professor Rigshospitalet, Denmark
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Responsible Party: Christina Andersen, RN, MPH, Ph.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02522520    
Other Study ID Numbers: CIRE-15
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Presently no plan to make IPD available to other researchers
Keywords provided by Christina Andersen, Rigshospitalet, Denmark:
Undergoing chemotherapy
Exercise intervention
Health counselling
Symptom management
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases