Clinical trial NCT03016728: Physical Activity for Adolescent and Young Adult Cancer Survivors
Official title: Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent and Young Adult Cancer Survivors
Keywords: exercise
physical activity
pilot study
randomized controlled trial
cancer
adolescent and young adult
AYA
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 17
Sex: ALL
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: INCLUSION CRITERIA:

1. Have been diagnosed with cancer for the first time between the ages of 15 and 39 years;
2. Have completed cancer treatment within 5 years;
3. Currently between the ages of 15 to 44 years;
4. 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);
5. Live within 100 km of the University of Ottawa;
6. 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;
7. Able to read, understand, and provide informed consent in English;
8. 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:

1. Physical impairments precluding participation in physical activity;
2. Unwilling or unable to sign the Participant Informed Consent Form;
3. 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:

1. Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks;
2. Able to read, understand, and provide informed consent in English for the additional assessments.

ADDITIONAL EXCLUSION CRITERIA:

1. Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
2. Claustrophobia;
3. Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
4. Lower back pain that would preclude a person from lying relatively still for one hour;
5. 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?).

Primary outcomes:
measure: Recruitment Rates
timeFrame: Through study completion, an average of 12-24 weeks
measure: Retention Rates
timeFrame: Through study completion, an average of 12-24 weeks
measure: Adherence Rates
timeFrame: Through study completion, an average of 12-24 weeks
measure: Number of Participants with Adverse Events
timeFrame: Through study completion, an average of 12-24 weeks
Secondary outcomes:
measure: Physical Activity Behaviour: Daily Physical Activity Logbook
timeFrame: Through study completion, an average of 12-24 weeks
measure: Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
measure: Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
measure: Resting Heart Rate
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Blood Pressure
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Body Composition: Body Mass Index
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: 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)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
timeFrame: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
measure: Participants Experiences: Qualitative Interviews
timeFrame: Baseline (week 0), post-intervention (week 12)
Other outcomes:
measure: Cognitive Functioning: Single Open-Ended Question
timeFrame: Baseline (week 0), post-intervention (week 12), follow-up (week 24)
measure: Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans
timeFrame: Baseline (week 0), post-intervention (week 12), follow-up (week 24)
measure: Socio-Demographic and Medical Information Questionnaire
timeFrame: Baseline (week 0)
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Jennifer Brunet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.
citation: Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.
citation: Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.
citation: 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.
citation: 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.
citation: Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.
citation: Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.