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

Sponsor
University of Ottawa (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03232814
Collaborator
(none)
0
1
1
11.8
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group-based walking
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Walk on: A Community-based Approach to Promote Participation in Physical Activity Among Men Treated for Colorectal Cancer
Actual Study Start Date :
Oct 5, 2017
Anticipated Primary Completion Date :
Sep 30, 2018
Anticipated Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group-based walking

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

Behavioral: Group-based walking
The walking prescription will be progressive in nature. The program will begin with participants walking for approximately 20 minutes in weeks 1-3. This will gradually increase to approximately 30 minutes in weeks 4-6. Finally, this will increase to 45-60 minutes in weeks 7-8. The program will promote walking at a moderate intensity as assessed by Borg's Rating of Perceived Exertion scale. Each session will be preceded by a brief warm-up and followed by a brief cool-down period.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Retention rates [Through study completion, an average of 8 weeks]

    The number of men who complete the intervention and all scheduled assessments.

  3. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Ottawa Ottawa Ontario Canada K1N 6N5

Sponsors and Collaborators

  • University of Ottawa

Investigators

  • Principal Investigator: Jennifer Brunet, PhD, University of Ottawa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jennifer Brunet, Associate Professor, University of Ottawa
ClinicalTrials.gov Identifier:
NCT03232814
Other Study ID Numbers:
  • WBCP:PA/CR
First Posted:
Jul 28, 2017
Last Update Posted:
Sep 17, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2018