Walk on: A Community-based Approach to Increase Physical Activity Among Men Treated for Colorectal Cancer

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Group-based walking

• Registration Number: NCT03232814
• Lead Sponsor: University of Ottawa

Brief Summary

In Canada, over 102,900 men are diagnosed with cancer each year. Of these, 81,000 are diagnosed with colorectal cancer and an estimated 65% are expected to survive the disease for at least 5 years. Men who have completed treatment for colorectal cancer face many adverse physical, cognitive, psychological, and social effects. The Wellness Beyond Cancer Program at The Ottawa Hospital is a cancer survivorship program that helps people who have completed treatment for cancer, including men diagnosed with colorectal cancer, manage these effects. The Wellness Beyond Cancer Program does this through education and referral to supportive care services and programs offered throughout the city of Ottawa.

Group-based physical activity programs are one of the varied services and programs available to adults diagnosed with cancer in Ottawa. Such programs are offered through the Ottawa Regional Cancer Foundation (http://www.ottawacancer.ca) and Breast Cancer Action Ottawa (http://bcaott.ca). Research on these programs show that group-based physical activity can improve disease and treatment-related effects while promoting overall quality of life amongst women with cancer. However, few of these programs have targeted men, even though their needs and preferences have been shown to be very different from women. While men diagnosed with colorectal cancer might also benefit from group-based physical activity programs offered in the community, it is not known if such programs would effectively reach them and what the impact would be on their quality of life after cancer treatment.

It is believed that a men's group-based walking program could be an effective way to reach men and promote quality of life after cancer treatment. Therefore, a sustainable 8-week group-based walking program was developed. This project will seek to explore the feasibility and potential benefits of the program among men who have completed treatment for colorectal cancer and who are referred to the program from staff at the Wellness Beyond Cancer Program in a prospective single-arm trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2017-10-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Men 18 years of age or older;
2. Have completed treatment for colorectal cancer <1 year;
3. Willing to provide informed consent to participate in this study and willing to follow the study protocol;
4. Have the ability to walk without the use of an assistive device (including a cane) or the help of another person;
5. Able to read and understand English;
6. Medically cleared to participate in the walking program as determined by their referring Wellness Beyond Cancer Program healthcare provider.

Exclusion Criteria

1. Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;
2. Uncontrolled hypertension (systolic blood pressure>200 mm Hg and/or diastolic blood pressure >110 mm Hg);
3. The use of supplemental oxygen;
4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
6. Hip fracture, hip or knee replacement in the past 6 months;
7. Currently enrolled in another study involving a physical activity intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group-based walking	Group-based walking	Participants will engage in one supervised outdoor group-based walking session per week for the 8 week program.

Primary Outcome Measures

Name	Time	Method
Recruitment rates	Through study completion, an average of 8 weeks	The number of men who enrol in the study out of the number who are referred.
Retention rates	Through study completion, an average of 8 weeks	The number of men who complete the intervention and all scheduled assessments.
Adherence rates	Through study completion, an average of 8 weeks	The number of walking sessions men engage in out of the total recommended as part of the intervention.

Secondary Outcome Measures

Name	Time	Method
Change in Physical Self-Perceptions: Physical Self Description Questionnaire Short-Form (Marsh et al., 2010)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported physical competence, confidence, and self-esteem from baseline to post-intervention.
Change in Stress: Perceived Stress Scale (Cohen et al., 1982)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported perceptions of stress from baseline to post-intervention.
Change in Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (Yellen et al., 1997)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported perceptions of fatigue from baseline to post-intervention.
Participants' Overall Experiences: Qualitative Interviews	Post-intervention (week 8)	Participants' perspectives on how the intervention contributed to their behavioural, physical, psychological and social functioning, as well as their overall quality of life.
Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Change in Quality of Life: Functional Assessment of Cancer Therapy (FACT)-Colorectal (Ward et al., 1999; Yost et al. 2005)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported quality of life from baseline to post-intervention.
Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported cognitive functioning from baseline to post-intervention.
Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported affect from baseline to post-intervention.
Change in Depression: Center for Epidemiologic Studies Depression Scale 10-item Revised (Eaton et al., 2004; Radloff, 1977)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported depressive symptoms from baseline to post-intervention.
Change in Social Support: Relatedness to Others in Physical Activity Scale (Wilson & Bengoechea, 2010)	Baseline (week 0) and post-intervention (week 8)	Change in participants' self-reported perceptions of social support from baseline to post-intervention.

Trial Locations

Locations (1)

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada