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

Primary Purpose

Colorectal Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group-based walking
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Ottawa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group-based walking

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment rates
The number of men who enrol in the study out of the number who are referred.
Retention rates
The number of men who complete the intervention and all scheduled assessments.
Adherence rates
The number of walking sessions men engage in out of the total recommended as part of the intervention.

Secondary Outcome Measures

Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
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)
Change in participants' self-reported quality of life from baseline to post-intervention.
Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
Change in participants' self-reported cognitive functioning from baseline to post-intervention.
Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
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)
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)
Change in participants' self-reported perceptions of social support from baseline to post-intervention.
Change in Physical Self-Perceptions: Physical Self Description Questionnaire Short-Form (Marsh et al., 2010)
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)
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)
Change in participants' self-reported perceptions of fatigue from baseline to post-intervention.
Participants' Overall Experiences: Qualitative Interviews
Participants' perspectives on how the intervention contributed to their behavioural, physical, psychological and social functioning, as well as their overall quality of life.

Full Information

First Posted
July 23, 2017
Last Updated
September 13, 2018
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT03232814
Brief Title
Walk on: A Community-based Approach to Increase Physical Activity Among Men Treated for Colorectal Cancer
Official Title
Walk on: A Community-based Approach to Promote Participation in Physical Activity Among Men Treated for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were recruited due to a lack of referrals.
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-based walking
Arm Type
Experimental
Arm Description
Participants will engage in one supervised outdoor group-based walking session per week for the 8 week program.
Intervention Type
Behavioral
Intervention Name(s)
Group-based walking
Intervention Description
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 Measure Information:
Title
Recruitment rates
Description
The number of men who enrol in the study out of the number who are referred.
Time Frame
Through study completion, an average of 8 weeks
Title
Retention rates
Description
The number of men who complete the intervention and all scheduled assessments.
Time Frame
Through study completion, an average of 8 weeks
Title
Adherence rates
Description
The number of walking sessions men engage in out of the total recommended as part of the intervention.
Time Frame
Through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Description
Change in participants' self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Quality of Life: Functional Assessment of Cancer Therapy (FACT)-Colorectal (Ward et al., 1999; Yost et al. 2005)
Description
Change in participants' self-reported quality of life from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
Description
Change in participants' self-reported cognitive functioning from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Description
Change in participants' self-reported affect from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Depression: Center for Epidemiologic Studies Depression Scale 10-item Revised (Eaton et al., 2004; Radloff, 1977)
Description
Change in participants' self-reported depressive symptoms from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Social Support: Relatedness to Others in Physical Activity Scale (Wilson & Bengoechea, 2010)
Description
Change in participants' self-reported perceptions of social support from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Physical Self-Perceptions: Physical Self Description Questionnaire Short-Form (Marsh et al., 2010)
Description
Change in participants' self-reported physical competence, confidence, and self-esteem from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Stress: Perceived Stress Scale (Cohen et al., 1982)
Description
Change in participants' self-reported perceptions of stress from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Change in Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (Yellen et al., 1997)
Description
Change in participants' self-reported perceptions of fatigue from baseline to post-intervention.
Time Frame
Baseline (week 0) and post-intervention (week 8)
Title
Participants' Overall Experiences: Qualitative Interviews
Description
Participants' perspectives on how the intervention contributed to their behavioural, physical, psychological and social functioning, as well as their overall quality of life.
Time Frame
Post-intervention (week 8)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men 18 years of age or older; Have completed treatment for colorectal cancer <1 year; Willing to provide informed consent to participate in this study and willing to follow the study protocol; Have the ability to walk without the use of an assistive device (including a cane) or the help of another person; Able to read and understand English; Medically cleared to participate in the walking program as determined by their referring Wellness Beyond Cancer Program healthcare provider. Exclusion Criteria: 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; Uncontrolled hypertension (systolic blood pressure>200 mm Hg and/or diastolic blood pressure >110 mm Hg); The use of supplemental oxygen; Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis); History of chest pain or severe shortness of breath either at rest or when engaging in physical activity; Hip fracture, hip or knee replacement in the past 6 months; Currently enrolled in another study involving a physical activity intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Brunet, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 6N5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6668417
Citation
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Results Reference
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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.
Results Reference
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PubMed Identifier
4053261
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Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
Results Reference
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PubMed Identifier
20733208
Citation
Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.
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Results Reference
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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.
Results Reference
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PubMed Identifier
10472150
Citation
Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999 May;8(3):181-95. doi: 10.1023/a:1008821826499.
Results Reference
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PubMed Identifier
3397865
Citation
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Results Reference
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Citation
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.
Results Reference
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Citation
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
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Citation
Yost KJ, Cella D, Chawla A, Holmgren E, Eton DT, Ayanian JZ, West DW. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol. 2005 Dec;58(12):1241-51. doi: 10.1016/j.jclinepi.2005.07.008. Epub 2005 Oct 13.
Results Reference
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Walk on: A Community-based Approach to Increase Physical Activity Among Men Treated for Colorectal Cancer

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