Clinical trial NCT03232814: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Recruitment rates
timeFrame: Through study completion, an average of 8 weeks
measure: Retention rates
timeFrame: Through study completion, an average of 8 weeks
measure: Adherence rates
timeFrame: Through study completion, an average of 8 weeks
Secondary outcomes:
measure: Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Quality of Life: Functional Assessment of Cancer Therapy (FACT)-Colorectal (Ward et al., 1999; Yost et al. 2005)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Depression: Center for Epidemiologic Studies Depression Scale 10-item Revised (Eaton et al., 2004; Radloff, 1977)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Social Support: Relatedness to Others in Physical Activity Scale (Wilson & Bengoechea, 2010)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Physical Self-Perceptions: Physical Self Description Questionnaire Short-Form (Marsh et al., 2010)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Stress: Perceived Stress Scale (Cohen et al., 1982)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Change in Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (Yellen et al., 1997)
timeFrame: Baseline (week 0) and post-intervention (week 8)
measure: Participants' Overall Experiences: Qualitative Interviews
timeFrame: Post-intervention (week 8)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Jennifer Brunet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
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.
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.
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.
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.