NCT03016728|Completed
Physical Activity for Adolescent and Young Adult Cancer Survivors
Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention
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Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention
Sponsor study identifier
interventional
17
1 country
1
Study Start
September 11, 2017
Actual (reported)Primary Completion
April 16, 2019
Actual (reported)Study Completion
May 5, 2019
Actual (reported)More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 24, 2016
Actual (reported)January 11, 2017
Actual (reported)September 11, 2017
Actual (reported)April 16, 2019
Actual (reported)May 5, 2019
Actual (reported)Recruitment Rates
The number of eligible participants who enrol in the study out of the number who are referred.
Through study completion, an average of 12-24 weeks
Retention Rates
The number of participants completing the intervention and all scheduled assessments.
Through study completion, an average of 12-24 weeks
Adherence Rates
The number of physical activity sessions engaged in out of the total recommended as part of the intervention.
Through study completion, an average of 12-24 weeks
Number of Participants with Adverse Events
The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.
Physical Activity Behaviour: Daily Physical Activity Logbook
Through study completion, an average of 12-24 weeks
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Resting Heart Rate
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Blood Pressure
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Cognitive Functioning: Single Open-Ended Question
Baseline (week 0), post-intervention (week 12), follow-up (week 24)
Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans
Baseline (week 0), post-intervention (week 12), follow-up (week 24)
Socio-Demographic and Medical Information Questionnaire
Baseline (week 0)
Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.
Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.
Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Ottawa
Ottawa, Ontario, K1N 6N5, Canada
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.
Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.
Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.
Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.
Jennifer Brunet, PhD
University of Ottawa
17 participants (actual enrollment reported by the registry).
First Submitted
December 24, 2016
First Posted
January 11, 2017
Study Start
September 11, 2017
Actual (reported)Physical Activity and Cognition Study
Through study completion, an average of 12-24 weeks
Contact the study team to confirm eligibility.
McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757.
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.
Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.
Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.
Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Wurz A, Ayson G, Smith AM, Brunet J. A proof-of-concept sub-study exploring feasibility and preliminary evidence for the role of physical activity on neural activity during executive functioning tasks among young adults after cancer treatment. BMC Neurol. 2021 Aug 4;21(1):300. doi: 10.1186/s12883-021-02280-y.
Wurz A, Price J, Brunet J. Understanding adolescents' and young adults' self-perceptions after cancer treatment in the context of a two-arm, mixed-methods pilot randomized controlled physical activity trial. Support Care Cancer. 2021 Aug;29(8):4439-4450. doi: 10.1007/s00520-020-05974-0. Epub 2021 Jan 15.
Wurz A, Brunet J. Exploring the feasibility and acceptability of a mixed-methods pilot randomized controlled trial testing a 12-week physical activity intervention with adolescent and young adult cancer survivors. Pilot Feasibility Stud. 2019 Dec 20;5:154. doi: 10.1186/s40814-019-0530-6. eCollection 2019.
Primary Completion
April 16, 2019
Actual (reported)Study Completion
May 5, 2019
Actual (reported)Last Updated
May 31, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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