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

NCT03232814 | Withdrawn

• 1 other identifier: WBCP:PA/CR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Recruitment rates

  The number of men who enrol in the study out of the number who are referred.

  Through study completion, an average of 8 weeks

• Retention rates

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

  Through study completion, an average of 8 weeks

• Adherence rates

  The number of walking sessions men engage in out of the total recommended as part of the intervention.

  Through study completion, an average of 8 weeks

Secondary Outcomes (10)

• Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)

  Baseline (week 0) and post-intervention (week 8)

• 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 Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)

  Baseline (week 0) and post-intervention (week 8)

• Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)

  Baseline (week 0) and post-intervention (week 8)

• 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)

Study Arms (1)

Group-based walking

EXPERIMENTAL

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

Behavioral: Group-based walking

Interventions

Group-based walking 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.

Group-based walking

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (11)

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  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.

  PMID: 4053261 BACKGROUND

• 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.

  PMID: 20733208 BACKGROUND

• 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.

  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.

  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.

  PMID: 10472150 BACKGROUND

• 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.

  PMID: 3397865 BACKGROUND

• 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.

  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.

  PMID: 9095563 BACKGROUND

• 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.

  PMID: 16291468 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jennifer Brunet, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 28, 2017
• Study Start: October 5, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)