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General Health Education Materials for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Grand River Regional Cancer Centre, Kitchener, CanadaColorectal Cancer+7 Morestudy of socioeconomic and demographic variables - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

Eligible Conditions
  • Colorectal Cancer
  • Depression
  • Anxiety Disorders
  • Fatigue
  • Exercise
  • Cognitive/Functional Impairment
  • Sleep Disorders
  • Psychosocial Impact of Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 10 years

10 years
Disease-free survival
Overall survival
Safety profile according to NCI CTCAE version 3.0
3 years
Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue
Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)
Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire
5 years
Economic evaluations including cost-effective analysis and cost utility analysis
Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires
Physical activity behavior as assessed by TPAQ

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
6MST VO2
1
VIP152 (BAY 1251152)
2
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Trial Design

2 Treatment Groups

General Health Education Materials
1 of 2
Physical Activity Program + General Health Education Materials
1 of 2

Active Control

962 Total Participants · 2 Treatment Groups

Primary Treatment: General Health Education Materials · No Placebo Group · N/A

General Health Education MaterialsActiveComparator Group · 7 Interventions: study of socioeconomic and demographic variables, Fitness testing, quality-of-life assessment, Educational Intervention, laboratory biomarker analysis, questionnaire administration, fatigue assessment and management · Intervention Types: Other, Other, Procedure, Other, Other, Other, Procedure
Physical Activity Program + General Health Education MaterialsActiveComparator Group · 9 Interventions: study of socioeconomic and demographic variables, educational intervention, exercise intervention, Fitness testing, quality-of-life assessment, laboratory biomarker analysis, questionnaire administration, fatigue assessment and management, counseling intervention · Intervention Types: Other, Other, Behavioral, Other, Procedure, Other, Other, Procedure, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years

Who is running the clinical trial?

Survivorship Research GroupUNKNOWN
Canadian Cancer Trials GroupLead Sponsor
116 Previous Clinical Trials
64,880 Total Patients Enrolled
Queen's University, BelfastOTHER
156 Previous Clinical Trials
132,534 Total Patients Enrolled
Kerry Courneya, PhDStudy ChairUniversity of Alberta
5 Previous Clinical Trials
871 Total Patients Enrolled
Janette Vardy, PhD, FRACPStudy ChairSydney Cancer Centre at Concord Repatriation General Hospital
Christopher Booth, MDStudy ChairCancer Centre of Southeastern Ontario at Kingston General Hospital

Eligibility Criteria

Age 18+ · All Participants · 30 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Refer to the details about the illness.
People with more than one type of colon cancer at the same time can participate.
You are able and willing to participate in a physical activity program, according to the investigator's assessment.
You have not had any other types of cancer except for certain types that were completely treated a while ago.

Who else is applying?

What state do they live in?
Ohio100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

How many participants are currently being recruited for this trial?

"Correct. According to the information on clinicaltrials.gov, this medical trial is actively recruiting patients since first being posted in December 2008 and recently updated in October 2022. There are 23 sites that need to enroll a total of 962 participants." - Anonymous Online Contributor

Unverified Answer

How many locations are administering this experimental trial?

"Presently, this medical research project is running in 23 centres across the nation; Toronto, Saskatoon, Edmonton and an additional 20 cities are all participating. To reduce strain associated with travel for patients involved in the trial, it may be wise to join a centre close by." - Anonymous Online Contributor

Unverified Answer

Is enrollment in this experiment still available for participants?

"According to the information listed on clinicaltrials.gov, this medical experiment is currently recruiting participants and has been since December 3rd 2008. The trial was last amended on October 7th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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