Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
2026年7月24日 更新者：Dr Katherine Lam、The Hong Kong Polytechnic University
Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer
The goal of this clinical trial is to learn if a digitalised Exercise Fit Tool (EFT) mobile application can promote physical activity in adolescents aged 12-18 years who have completed treatment for hematologic cancer (e.g., leukaemia and lymphoma). The main questions it aims to answer are:
- Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
- Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months?
Researchers will compare the digitalised EFT intervention group to a usual care group to see if the mobile application can promote physical activity levels, physical activity self-efficacy, and quality of life in adolescents with hematologic cancer.Participants will:
- Receive a 20-minute educational session on how to use the mobile application
- Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
- Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
- Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
30
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。
研究連絡先
- 名前：Ka Wai Katherine LAM, Doctor of Philosophy
- 電話番号：+852 27666420
- メール：kw-katherine.lam@polyu.edu.hk
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
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- (1) they are 12-18 years old;
- (2) they had been diagnosed with hematologic cancer such as leukaemia and lymphoma;
- (3) they are regarded by the responsible physicians as stable, able to conduct PA, and without any PA restrictions,
- (4) they completed all cancer treatment;
- (5) they speak Cantonese and read Chinese.
Exclusion Criteria:
- (1) Receiving palliative care
- (2) Have physical or cognitive impairment and learning problems as identified from medical records
- (3) Identified by physicians that no physical activity should be conducted at the time of recruitment
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：普段のお手入れ
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Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
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実験的：Digitalised EFT intervention
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Participants in the intervention group will be delivered a 20-minute educational session to the participants.
During this session, participants will be educated about the introduction and operation of the mobile application.
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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 |
|---|---|---|
|
Screening rate
時間枠：During the recruitment period (up to 6 months)
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Calculated as the number of participants screened at participating hospital divided by number of participants at participated hospitals during the recruitment period.
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During the recruitment period (up to 6 months)
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Eligibility rate
時間枠：During the recruitment period (up to 6 months)
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Calculated by dividing the number of participants who are eligible by the number who are screened.
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During the recruitment period (up to 6 months)
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Consent rate
時間枠：During the recruitment period (up to 6 months)
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Calculated by dividing the number of participants who consent to join the study by the number who are eligible.
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During the recruitment period (up to 6 months)
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Randomization rate
時間枠：Time Point 1 (at 1 month after intervention)
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Calculated by dividing the number of participants who are randomized into intervention and control groups by those who provide consent.
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Time Point 1 (at 1 month after intervention)
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Attendance rate
時間枠：Time Point 1 (at 1 month after intervention)
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Calculated by dividing the number of participants who complete the intervention by those who are randomized
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Time Point 1 (at 1 month after intervention)
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Retention rate
時間枠：Time Point 3 (at 6 months after intervention)
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Calculated by dividing the number of participants who remain in the study by those who are randomized.
Retention rates for the intervention and control groups will be calculated at each follow-up.
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Time Point 3 (at 6 months after intervention)
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Adherence rate
時間枠：Time Point 1 (at 1 month after intervention)
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Calculated by dividing the number of participants students who follow the intervention protocol by those who are randomized.
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Time Point 1 (at 1 month after intervention)
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Complete rate
時間枠：Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)
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Calculated by dividing the number of participants who returned questionnaires by the number of questionnaires distributed.
This will be calculated by groups at baseline and each follow-up.
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Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)
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Proportion of missing data
時間枠：Time Point 3 (at 6 months after the intervention)
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Calculated as the percentage of missing values in the dataset.
Unknown or blank values will be considered missing values.
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Time Point 3 (at 6 months after the intervention)
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Adverse events
時間枠：Time Point 3 (at 6 months after the intervention)
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Adverse events are defined as unfavourable and unintended events that are not present at baseline or appear to have worsened during the study.
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Time Point 3 (at 6 months after the intervention)
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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 (PA) levels
時間枠：Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
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Physical activity (PA) levels assessed via accelerometers.
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Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
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Physical activity (PA) levels
時間枠：Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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Physical activity (PA) levels assessed via self-reports.
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Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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Physical Activity Self-Efficacy (PASE)
時間枠：Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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It comprises five items on a three-point Likert scale, with scores ranging from 5 to 15.
Higher scores indicate higher levels of PASE.
Its psychometric properties have been examined in Chinese adolescents with cancer, with good content validity and test.
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Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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Quality of life (QoL)
時間枠：Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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Participants' QoL will be measured using child specific EQ-5D-Y-5L scale, which is validated in ages 8-15 via self-report.
A published algorithm will be used to convert the scores into a single utility score.
Scores range from 0 to 100, with higher scores indicating better QoL
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Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
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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。
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 (推定)
2026年7月20日
一次修了 (推定)
2027年7月19日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月27日
QC基準を満たした最後の更新が送信されました
2026年7月24日
最終確認日
2026年7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。