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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
17
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.
University of Ottawa
Ottawa, Ontario, Canada
Recruitment Rates
The number of eligible participants who enrol in the study out of the number who are referred.
Time frame: Through study completion, an average of 12-24 weeks
Retention Rates
The number of participants completing the intervention and all scheduled assessments.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 12-24 weeks
Physical Activity Behaviour: Daily Physical Activity Logbook
Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Time frame: Through study completion, an average of 12-24 weeks
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Time frame: 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)
Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Resting Heart Rate
Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Blood Pressure
Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Body Composition: Body Mass Index
Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)
Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)
Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, & Jackson, 2010)
Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)
Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)
Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)
Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.
Time frame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Participants Experiences: Qualitative Interviews
Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.
Time frame: Baseline (week 0), post-intervention (week 12)
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