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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pedometer intervention
Pedometer + hospital based intervention
Omron Walking Style pro. 20
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring Undergoing chemotherapy, Exercise intervention, Health counselling, Symptom management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pedometer intervention

Pedometer + hospital based intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximum oxygen uptake - ( VO2 peak)
Assessed with objective physiological test

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2015
Last Updated
April 19, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen University Hospital at Herlev, Novo Nordisk A/S, Danish Cancer Society, TrygFonden, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02522520
Brief Title
Pedometer Intervention and Health Effects for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy
Official Title
Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
September 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen University Hospital at Herlev, Novo Nordisk A/S, Danish Cancer Society, TrygFonden, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Undergoing chemotherapy, Exercise intervention, Health counselling, Symptom management

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Primary outcome (VO2 peak) Physiological tests assessors blinded
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pedometer intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pedometer + hospital based intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pedometer intervention
Intervention Description
12 weeks physical activity intervention (supervised/non-supervised)
Intervention Type
Behavioral
Intervention Name(s)
Pedometer + hospital based intervention
Intervention Description
12 weeks physical activity intervention (supervised/non-supervised)
Intervention Type
Device
Intervention Name(s)
Omron Walking Style pro. 20
Other Intervention Name(s)
Pedometer
Primary Outcome Measure Information:
Title
Maximum oxygen uptake - ( VO2 peak)
Description
Assessed with objective physiological test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health related Quality of Life
Description
Assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, specifically for colon cancer patients
Time Frame
From baseline to 39 weeks
Title
Symptoms and side-effects
Description
Assessed by MD Andersen symptom questionnaire and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, chemotherapy-induced peripheral neuropathy
Time Frame
From baseline to 39 weeks
Title
Anxiety and Depression
Description
Assessed by The Hospital Anxiety and Depression Scale
Time Frame
From baseline to 39 weeks
Title
Lifestyle factors
Description
Assessed by smoking cessation, alcohol, diet
Time Frame
From baseline to 39 weeks
Title
Physical activity level
Description
Assessed by the International Physical Activity Questionnaire
Time Frame
From baseline to 39 weeks
Title
Dual Energy X-ray Absorptiometry scan
Description
Assessed by dual energy x-ray absorptiometry.
Time Frame
From baseline to 39 weeks
Title
Blood cholesterols
Description
Assessed by blood samples
Time Frame
From baseline to 39 weeks
Title
Blood pressure / pulse
Description
Assessed by Heart Rate Monitor during the hospital-based intervention
Time Frame
From 6 to 12 weeks
Title
Pedometer Step Count
Description
Assessed by Omron Walking Style pro. 20 with electronic data transmission
Time Frame
From baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lis Adamsen, Professor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Presently no plan to make IPD available to other researchers

Learn more about this trial

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

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