Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity | Experimental | 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. |
|
| Wait-List Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 12-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion, an average of 12-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Functioning: Single Open-Ended Question | Change in participants responses to a single open-ended question: "Do you ever feel like you have a hard time thinking and/or remembering?" from baseline, to post-intervention, to follow-up. NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments. |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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:
ADDITIONAL EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Brunet, PhD | University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa | Ottawa | Ontario | K1N 6N5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4053261 | Background | 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. | |
| Background | Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013. | ||
| Background | Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012. | ||
| Background | Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001. | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (week 0), post-intervention (week 12) |
| Baseline (week 0), post-intervention (week 12), follow-up (week 24) |
| Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans | Change in participants cognitive functioning, as assessed by a structural scan, a resting state functional MRI (fMRI) procedure, four fMRI tasks, and a diffusion tensor imaging sequence (lasting approximately 60 minutes), from baseline, to post-intervention, to follow-up. NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments. | Baseline (week 0), post-intervention (week 12), follow-up (week 24) |
| Socio-Demographic and Medical Information Questionnaire | The socio-demographic and medical information collected will be used to describe the sample. | Baseline (week 0) |
| Background |
| 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. |
| 20733208 | Background | 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. |
| Background | Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965. |
| Background | Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000. |
| 8827649 | Background | 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. |
| 1593914 | Background | 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. |
| 34344355 | Derived | 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. |
| 33449169 | Derived | 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. |
| 31890266 | Derived | 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. |