Physical Activity for Adolescent and Young Adult Cancer Survivors
2019年5月29日 更新者：Jennifer Brunet、University of Ottawa
Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention
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.
研究概览
研究类型
介入性
注册 (实际的)
17
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Ottawa、Ontario、加拿大、K1N 6N5
- University of Ottawa
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 44年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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?).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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.
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无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Recruitment Rates
大体时间：Through study completion, an average of 12-24 weeks
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The number of eligible participants who enrol in the study out of the number who are referred.
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Through study completion, an average of 12-24 weeks
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Retention Rates
大体时间：Through study completion, an average of 12-24 weeks
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The number of participants completing the intervention and all scheduled assessments.
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Through study completion, an average of 12-24 weeks
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Adherence Rates
大体时间：Through study completion, an average of 12-24 weeks
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The number of physical activity sessions engaged in out of the total recommended as part of the intervention.
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Through study completion, an average of 12-24 weeks
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Number of Participants with Adverse Events
大体时间：Through study completion, an average of 12-24 weeks
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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.
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Through study completion, an average of 12-24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Physical Activity Behaviour: Daily Physical Activity Logbook
大体时间：Through study completion, an average of 12-24 weeks
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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).
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Through study completion, an average of 12-24 weeks
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Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
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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).
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
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Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
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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).
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
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Resting Heart Rate
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Blood Pressure
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Body Composition: Body Mass Index
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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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.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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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.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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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)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
大体时间：Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.
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Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
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Participants Experiences: Qualitative Interviews
大体时间：Baseline (week 0), post-intervention (week 12)
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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.
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Baseline (week 0), post-intervention (week 12)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Cognitive Functioning: Single Open-Ended Question
大体时间：Baseline (week 0), post-intervention (week 12), follow-up (week 24)
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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. |
Baseline (week 0), post-intervention (week 12), follow-up (week 24)
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Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans
大体时间：Baseline (week 0), post-intervention (week 12), follow-up (week 24)
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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)
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Socio-Demographic and Medical Information Questionnaire
大体时间：Baseline (week 0)
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The socio-demographic and medical information collected will be used to describe the sample.
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Baseline (week 0)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jennifer Brunet, PhD、University of Ottawa
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- Canadian Society for Exercise Physiology (CSEP). CSEP-Physical activity training for health (CSEP-PATH). Ottawa, ON: CSEP, 2013.
- Irwin, ML. American College of Sports Medicine's guide to exercise and cancer survivorship. Champaign, IL: Human Kinetics, 2012.
- Rikli R, Jones J. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001.
- 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. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.
- Rosenberg M. Soceity and adolescent self-image. Princeton, NJ: Princeton University Press, 1965.
- Cash TF. The multidimensional body-self relations questionnaire. MBSRQ Users' Manual 3rd Revision. Available: http://www.body-images.com, 2000.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月11日
初级完成 (实际的)
2019年4月16日
研究完成 (实际的)
2019年5月5日
研究注册日期
首次提交
2016年12月24日
首先提交符合 QC 标准的
2017年1月6日
首次发布 (估计)
2017年1月11日
研究记录更新
最后更新发布 (实际的)
2019年5月31日
上次提交的符合 QC 标准的更新
2019年5月29日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Physical Activity的临床试验
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Weill Medical College of Cornell UniversityWeill Cornell Medical College in Qatar撤销
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University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC完全的