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

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ClinicalTrials.gov Identifier: NCT03232814
Recruitment Status : Withdrawn (No participants were recruited due to a lack of referrals.)
First Posted : July 28, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Brunet, 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Group-based walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : October 5, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Recruitment rates [ Time Frame: 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 [ Time Frame: Through study completion, an average of 8 weeks ]
    The number of men who complete the intervention and all scheduled assessments.

  3. Adherence rates [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232814


Locations
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Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1N 6N5
Sponsors and Collaborators
University of Ottawa
Investigators
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Principal Investigator: Jennifer Brunet, PhD University of Ottawa

Publications:
Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R), in The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, M.E. Maruish, Editor. 2004, Lawrence Erlbaum: Mahwah, NJ. p. 363-377.
Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement, 1977. 1: p. 385-401.
Wagner L, Lai J-S, Cella D, Sweet J, Forrestal S. Chemotherapy-related cognitive deficits: development of the FACT-Cog instrument. Ann Behav Med, 2004. 27: p. S10.
Wilson PM, Bengoechea EG. The relatedness to others in physical activity scale: evidence for structural and criterion validity. Journal of Applied Biobehavioral Research, 2010. 15(2): p. 61-87.

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Responsible Party: Jennifer Brunet, Associate Professor, University of Ottawa
ClinicalTrials.gov Identifier: NCT03232814     History of Changes
Other Study ID Numbers: WBCP:PA/CR
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases