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.
調査の概要
研究の種類
介入
入学 (実際)
17
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1N 6N5
- University of Ottawa
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年～44年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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?).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment Rates
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Physical Activity Behaviour: Daily Physical Activity Logbook
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Cognitive Functioning: Single Open-Ended Question
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jennifer Brunet, PhD、University of Ottawa
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年9月11日
一次修了 (実際)
2019年4月16日
研究の完了 (実際)
2019年5月5日
試験登録日
最初に提出
2016年12月24日
QC基準を満たした最初の提出物
2017年1月6日
最初の投稿 (見積もり)
2017年1月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月31日
QC基準を満たした最後の更新が送信されました
2019年5月29日
最終確認日
2019年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Physical Activityの臨床試験
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Centre Hospitalier Universitaire de Besancon募集
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University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
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University Hospital, Toulouse積極的、募集していない
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Saglik Bilimleri UniversitesiMedical Park Hospital Istanbul完了
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Istanbul University - Cerrahpasa完了