Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ottawa
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Recruitment Rates
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 44 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have been diagnosed with cancer for the first time between the ages of 15 and 39 years;
- •Have completed cancer treatment within 5 years;
- •Currently between the ages of 15 to 44 years;
- •Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells that have spread from the primary cancer), or second cancers (i.e., a new different cancer);
- •Live within 100 km of the University of Ottawa;
- •Be inactive or insufficiently active as determined by a single item screening question (i.e., participants must respond "no" to the following question: are you currently engaging in moderate physical activity, defined as activity that increases your heart rate and causes you to sweat, on 3 or more days a week?). Screening participants based on their level of physical activity will ensure only those individuals for whom the intervention will have the largest effect are recruited;
- •Able to read, understand, and provide informed consent in English;
- •Ready for physical activity as indicated by answering Physical Activity Readiness Questions (PAR-Q). If participants are not ready for physical activity as determined by the PAR-Q they will need to complete a Physical Activity Readiness Medical Examination Form.
Exclusion Criteria
- •Physical impairments precluding participation in physical activity;
- •Unwilling or unable to sign the Participant Informed Consent Form;
- •Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest.
- •Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria.
- •ADDITIONAL INCLUSION CRITERIA:
- •Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks;
- •Able to read, understand, and provide informed consent in English for the additional assessments.
- •ADDITIONAL EXCLUSION CRITERIA:
- •Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
- •Claustrophobia;
- •Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
- •Lower back pain that would preclude a person from lying relatively still for one hour;
- •Substance use disorder as assessed by a single item question (i.e., participants must respond "no" to the following question: Have you been told, in the last five years, by your healthcare provider that you have a substance use disorder?).
Arms & Interventions
Physical Activity
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.
Intervention: Physical Activity (Behavioral)
Wait-List Control
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.
Outcomes
Primary Outcomes
Recruitment Rates
Time Frame: Through study completion, an average of 12-24 weeks
The number of eligible participants who enrol in the study out of the number who are referred.
Adherence Rates
Time Frame: Through study completion, an average of 12-24 weeks
The number of physical activity sessions engaged in out of the total recommended as part of the intervention.
Number of Participants with Adverse Events
Time Frame: Through study completion, an average of 12-24 weeks
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.
Retention Rates
Time Frame: Through study completion, an average of 12-24 weeks
The number of participants completing the intervention and all scheduled assessments.
Secondary Outcomes
- Physical Activity Behaviour: Daily Physical Activity Logbook(Through study completion, an average of 12-24 weeks)
- Resting Heart Rate(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- 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))
- Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)(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)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- 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))
- Blood Pressure(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Body Composition: Body Mass Index(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)(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)(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)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
- Participants Experiences: Qualitative Interviews(Baseline (week 0), post-intervention (week 12))
Investigators
Jennifer Brunet
PhD, Assistant Professor
University of Ottawa