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

NCT ID: NCT03232814

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group-based walking

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

Group Type EXPERIMENTAL

Group-based walking

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Ottawa

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Brunet

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Brunet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Locations

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University of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 4053261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20733208 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10472150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3397865 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9095563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16291468 (View on PubMed)

Other Identifiers

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WBCP:PA/CR

Identifier Type: -

Identifier Source: org_study_id

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