Physical Activity for Adolescent and Young Adult Cancer Survivors

NCT ID: NCT03016728

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2019-05-05

Brief Summary

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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.

Detailed Description

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Conditions

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Adolescent and Young Adult Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Physical Activity

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical Activity

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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.

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.



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?).
Minimum Eligible Age

15 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ottawa

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Brunet

PhD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Brunet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Locations

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University of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 4053261 (View on PubMed)

Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.

Reference Type BACKGROUND

Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.

Reference Type BACKGROUND

Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.

Reference Type 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.

Reference Type BACKGROUND
PMID: 8433355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20733208 (View on PubMed)

Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.

Reference Type BACKGROUND

Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.

Reference Type 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.

Reference Type BACKGROUND
PMID: 8827649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1593914 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34344355 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33449169 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31890266 (View on PubMed)

Other Identifiers

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Ottawa

Identifier Type: -

Identifier Source: org_study_id

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