NCT02522520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

August 4, 2015

Last Update Submit

April 19, 2023

Conditions

Colorectal Cancer

Keywords

Undergoing chemotherapyExercise interventionHealth counsellingSymptom management

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake - ( VO2 peak)

    Assessed with objective physiological test

    12 weeks

Secondary Outcomes (9)

  • Health related Quality of Life

    From baseline to 39 weeks

  • Symptoms and side-effects

    From baseline to 39 weeks

  • Anxiety and Depression

    From baseline to 39 weeks

  • Lifestyle factors

    From baseline to 39 weeks

  • Physical activity level

    From baseline to 39 weeks

  • +4 more secondary outcomes

Study Arms (2)

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.

Behavioral: Pedometer interventionDevice: 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.

Behavioral: Pedometer + hospital based interventionDevice: Omron Walking Style pro. 20

Interventions

Pedometer interventionBEHAVIORAL

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

Pedometer intervention
Pedometer + hospital based interventionBEHAVIORAL

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

Pedometer + hospital based intervention
Omron Walking Style pro. 20DEVICE
Also known as: Pedometer
Pedometer + hospital based interventionPedometer intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Myocardial infarction within the past six months
  • Symptomatic heart failure
  • Known angina pectoris
  • Contraindication for moderate to strenuous physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Lis Adamsen, Professor

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary outcome (VO2 peak) Physiological tests assessors blinded
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MPH, Ph.D.

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2020

Study Completion

September 1, 2021

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Presently no plan to make IPD available to other researchers

Locations

DK(1)