Colorectal CancerNCT03232814

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

A study testing Group-based walking in people with Colorectal Cancer, run by University of Ottawa at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Colorectal Cancer
What is being tested?: Group-based walking
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteCanada
Study dates: 5 Oct 2017to 30 Sep 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Ottawa
Ottawa, Ontario, K1N 6N5

Other trials in Canada

About this study

Official title: Walk on: A Community-based Approach to Promote Participation in Physical Activity Among Men Treated for Colorectal Cancer

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
Being tested: Group-based walking
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group-based walkingBehavioural
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.

Study groups in NCT03232814
Study group	Role	What they receive
Group-based walking	Experimental	Participants will engage in one supervised outdoor group-based walking session per week for the 8 week program. Receives: Behavioral: Group-based walking

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment rates
The number of men who enrol in the study out of the number who are referred.
Measured: Through study completion, an average of 8 weeks
Retention rates
The number of men who complete the intervention and all scheduled assessments.
Measured: 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.
Measured: Through study completion, an average of 8 weeks

Secondary outcomes (10)

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.
Measured: 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)
Change in participants' self-reported quality of life from baseline to post-intervention.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
Change in participants' self-reported cognitive functioning from baseline to post-intervention.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Change in participants' self-reported affect from baseline to post-intervention.
Measured: 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)
Change in participants' self-reported depressive symptoms from baseline to post-intervention.
Measured: Baseline (week 0) and post-intervention (week 8)
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.
Measured: Baseline (week 0) and post-intervention (week 8)
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.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in Stress: Perceived Stress Scale (Cohen et al., 1982)
Change in participants' self-reported perceptions of stress from baseline to post-intervention.
Measured: Baseline (week 0) and post-intervention (week 8)
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.
Measured: Baseline (week 0) and post-intervention (week 8)
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.
Measured: Post-intervention (week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 201730 Sep 2018

First posted28 Jul 2017
Study start5 Oct 2017
Primary completion30 Sep 2018 (estimated)
Study completion30 Sep 2018 (estimated)

Why it stopped: No participants were recruited due to a lack of referrals.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03232814
Sponsor's protocol ID: WBCP:PA/CR
Status last verified: Sep 2018
First submitted: 23 Jul 2017
Last updated: 17 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 6668417
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.
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.
PubMed 4053261
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.
PubMed 20733208
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.
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.
PubMed 10472150
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.
PubMed 3397865
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.
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.
PubMed 9095563
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.
PubMed 16291468

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Walk on: A Community-based Approach to Promote Participation in Physical Activity Among Men Treated for Colorectal Cancer
ClinicalTrials.gov ID: NCT03232814
Acronym / sponsor ID: WBCP:PA/CR
Conditions: Colorectal Cancer
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No participants were recruited due to a lack of referrals.
Enrolment: 0 participants (actual)
Lead sponsor: University of OttawaUniversity, hospital or other
Study start: 5 Oct 2017 (actual)
Primary completion: 30 Sep 2018 (estimated)
Study completion: 30 Sep 2018 (estimated)
First posted: 28 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group-based walking	Experimental	Behavioral: Group-based walkingParticipants will engage in one supervised outdoor group-based walking session per week for the 8 week program.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group-based walkingThe 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.	Behavioural	Group-based walking

Primary outcome

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.
Retention rates
Time frame: Through study completion, an average of 8 weeks
The number of men who complete the intervention and all scheduled assessments.
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.

10 secondary outcomes

Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Time frame: 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)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Time frame: 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)
Time frame: Baseline (week 0) and post-intervention (week 8)
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 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 Stress: Perceived Stress Scale (Cohen et al., 1982)
Time frame: Baseline (week 0) and post-intervention (week 8)
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)
Participants' Overall Experiences: Qualitative Interviews
Time frame: Post-intervention (week 8)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
BackgroundEaton 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: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
Background: PubMed 20733208Marsh 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.
BackgroundRadloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement, 1977. 1: p. 385-401.
BackgroundWagner 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: PubMed 10472150Ward 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.
Background: PubMed 3397865Watson 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.
BackgroundWilson 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: PubMed 9095563Yellen 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.
Background: PubMed 16291468Yost 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Brunet, PhD principal investigator

University of Ottawa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group-based walking in people with Colorectal Cancer, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rates (time frame: Through study completion, an average of 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03232814, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.