Physical Activity for Adolescent and Young Adult Cancer Survivors

NCT03016728 | Completed

• 1 other identifier: Ottawa
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent and Young Adult Cancer Survivors

Keywords

exercise; physical activity; pilot study; randomized controlled trial; cancer; adolescent and young adult; AYA

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (16)

• 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)

Other Outcomes (3)

• 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)

Study Arms (2)

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.

Behavioral: Physical Activity

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.

Interventions

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.

Physical Activity

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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?).

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (13)

• 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.

  PMID: 4053261 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.

  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.

  PMID: 8433355 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.

  PMID: 20733208 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.

  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.

  PMID: 8827649 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 34344355 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.

  PMID: 33449169 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.

  PMID: 31890266 DERIVED

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Brunet, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Study Record Dates

• First Submitted: December 24, 2016
• First Posted: January 11, 2017
• Study Start: September 11, 2017
• Primary Completion: April 16, 2019
• Study Completion: May 5, 2019
• Last Updated: May 31, 2019

Record last verified: 2019-05

Locations

CA (1)