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

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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Pedometer intervention; Device: Omron Walking Style pro. 20; Behavioral: Pedometer + hospital based intervention

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.	Device: Omron Walking Style pro. 20; Other Names: Pedometer; Behavioral: Pedometer + hospital based intervention; 12 weeks physical activity intervention (supervised/non-supervised)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Novo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society; TrygFonden, Denmark
• Investigators: Study Director: Lis Adamsen, Professor, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Symptom management; Exercise intervention; Undergoing chemotherapy; Health counselling
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CIRE-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Presently no plan to make IPD available to other researchers