Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL) (STEP-ALL)
Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.
Treatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.
Effective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.
This study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jessica Buddenbaum, MS
- 電話番号：919-966-4432
- メール：jessica_buddenbaum@med.unc.edu
研究連絡先のバックアップ
- 名前：Juanita Cuffee
- 電話番号：919-216-0463
- メール：cuffee@med.unc.edu
研究場所
-
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- 募集
- University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
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コンタクト：
- Juanita Cuffee
- 電話番号：919-966-0017
- メール：cuffee@med.unc.edu
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コンタクト：
- Jessica Buddenbaum, MS
- メール：jessica_buddenbaum@med.unc.edu
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主任研究者：
- Thomas Alexander, MD, MPH
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria for children:
All subjects must meet the following criteria:
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental/legal guardian consent.
- Age >= 6 and < =21 years at the time of diagnosis.
- Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Exclusion Criteria for children:
- Subjects must not be receiving any investigational or additional anti-cancer medicines during induction.
- Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results.
Optional caregiver participation:
Inclusion Criteria :All caregivers must meet the following criteria
- Written informed consent to participate in the caregiver interviews.
- The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be <18 years
研究計画
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：非ランダム化
- 介入モデル：単一グループの割り当て
- 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：Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)
Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program.
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Participants will follow a strength-training routine using rubber resistance bands and their own body weight, completing exercises at least three times per week and recording the time spent on their study form.
They will receive ongoing support through optional Zoom or phone check-ins, with the choice to join group online sessions or complete supervised sessions individually.
The intervention begins Day 8 and continues through Consolidation Day 29.
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介入なし：Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)
Caregivers of Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program.
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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 |
|---|---|---|
|
Proportion of subjects completed exercise intervention
時間枠：Up to 9 weeks
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The proportion of subjects who attend at least 16 of 24 total (3 per week) exercise sessions and complete ≥ 60% of the prescribed exercise plan.
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Up to 9 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 |
|---|---|---|
|
Ability to capture weekly functional activity
時間枠：Up to 9 weeks
|
The proportion of subjects who have ≥ 75% of functional profile variables successfully collected in at least 75% (18 of 24) of sessions.
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Up to 9 weeks
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協力者と研究者
捜査官
- 主任研究者：Thomas Alexander, MD, MPH、UNC Lineberger Comprehensive Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- LCCC2541
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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