Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors (TLCFIT)
2021年4月7日 更新者：Katie Devine, PhD, MPH、Rutgers, The State University of New Jersey
Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
This clinical trial studies a mobile health fitness program for adolescent and young adult childhood cancer survivors.
Adolescent and young adult childhood cancer survivors are at risk to have negative late effects from treatment and to develop chronic health conditions.
A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early mortality.
Physical activity reduces the risk for cardiovascular disease and early mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and it is also positively associated with quality of life.
Programs and technologies that promote physical activity are important because health behaviors adopted by adolescent and young adult childhood cancer survivors are likely to continue into adulthood.
A mobile health fitness application may motivate adolescent and young adult childhood cancer survivors to engage and maintain physical activity.
調査の概要
状態
完了
詳細な説明
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.
SECONDARY OBJECTIVES:
I. Determine the effectiveness of the technology-enhanced fitness program on participants' cardiorespiratory fitness and muscular fitness.
II. Examine the effects of the program on secondary outcomes of health related quality of life (HRQOL) and fatigue.
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I (Intervention): Participants attend 8 group meetings weekly, wear an electronic accelerometer, engage in private social support messaging within the app and Facebook private groups, and then use the mobile app for 4 weeks without in-person groups.
ARM II (WAITLIST CONTROL [WLC]): After the 6 month assessment, participants receive the FitSurvivor intervention as in arm I.
研究の種類
介入
入学 (実際)
49
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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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
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New Brunswick、New Jersey、アメリカ、08903
- Rutgers Cancer Institute of New Jersey
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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
13年～25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:
- Any diagnosis of cancer prior to age 21
- Off treatment for at least 6 months
- For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent
Exclusion Criteria:
- Any medical contraindication to exercise according to a physician or physician's designee
- Non-English speaking
- Current physical activity level exceeding Centers for Disease Control and Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for 5+ days/week (wk) including 3+ days of vigorous intensity activities and muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+ days/wk for children < 18 and 150 min of moderate vigorous exercise or 75 min of vigorous exercise/wk and 2+ days of muscle strengthening activities for adults >= 18); the CDC guidelines are used to determine exercise prescription in our intervention; individuals already exceeding the guidelines would be unlikely to benefit from participating
- Significant developmental delay per patient, parent, or physician report
- Pregnant (per patient report); if participant becomes pregnant during the course of the study, she will be removed from further participation
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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アクティブコンパレータ：Arm I (Intervention)
Assessment including
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補助研究
他の名前：
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
他の名前：
|
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アクティブコンパレータ：Arm II (Waitlist Control [WLC])
Assessment including
After waiting 6 months they will begin the fitness program as described in Arm I |
補助研究
他の名前：
Participate in fitness program
Engage in private social support messaging and Use the mobile app
Wear an electronic accelerometer
他の名前：
|
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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Feasibility of the Technology-enhanced Fitness Program
時間枠：Baseline
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Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial.
In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).
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Baseline
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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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Feasibility - Retention
時間枠：Baseline to post-intervention (3 months)
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Percentage of participants who compete the 3 month assessment
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Baseline to post-intervention (3 months)
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Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
時間枠：Baseline to post-intervention (3 months)
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Fatigue measured using the PedsQL Multidimensional Fatigue Scale.
The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue.
Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.
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Baseline to post-intervention (3 months)
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Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
時間枠：Baseline to post-intervention (3 months)
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The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains.
The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary.
Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.
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Baseline to post-intervention (3 months)
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Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
時間枠：Baseline to post-intervention (3 months)
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Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol.
This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade.
Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor.
Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.
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Baseline to post-intervention (3 months)
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Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
時間枠：Baseline to post-intervention (3 months)
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Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body).
Weight was increased until participants executed 10 repetitions in good form for both exercises.
Estimates of 1-RM leg and bench press were made using a linear prediction equation.
Higher scores indicate greater muscular strength/endurance.
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Baseline to post-intervention (3 months)
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Feasibility - Engagement With the App
時間枠：Duration of the FitSurvivor intervention (12 weeks)
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Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed.
These are count data.
Achievements unlocked has possible range of 0 to 20.
Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each.
The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.
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Duration of the FitSurvivor intervention (12 weeks)
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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。
捜査官
- 主任研究者：Katie Devine、Rutgers Cancer Institute of New Jersey
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)
2014年1月2日
一次修了 (実際)
2018年5月22日
研究の完了 (実際)
2018年7月30日
試験登録日
最初に提出
2015年11月30日
QC基準を満たした最初の提出物
2016年2月17日
最初の投稿 (見積もり)
2016年2月23日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月9日
QC基準を満たした最後の更新が送信されました
2021年4月7日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Pro2013003658
- P30CA072720 (米国 NIH グラント/契約)
- NCI-2015-01841 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 131323 (その他の識別子：Rutgers Cancer Institute of New Jersey)
- K07CA174728 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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