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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jessica Buddenbaum, MS
- Telefonnummer: 919-966-4432
- E-post: jessica_buddenbaum@med.unc.edu
Studera Kontakt Backup
- Namn: Juanita Cuffee
- Telefonnummer: 919-216-0463
- E-post: cuffee@med.unc.edu
Studieorter
-
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- Rekrytering
- University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
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Kontakt:
- Juanita Cuffee
- Telefonnummer: 919-966-0017
- E-post: cuffee@med.unc.edu
-
Kontakt:
- Jessica Buddenbaum, MS
- E-post: jessica_buddenbaum@med.unc.edu
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Huvudutredare:
- Thomas Alexander, MD, MPH
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of subjects completed exercise intervention
Tidsram: Up to 9 weeks
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ability to capture weekly functional activity
Tidsram: Up to 9 weeks
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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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Thomas Alexander, MD, MPH, UNC Lineberger Comprehensive Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Kroppsvikt
- Immunsystemets sjukdomar
- Förändringar i kroppsvikt
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Leukemi, lymfoid
- Patologiska tillstånd, tecken och symtom
- Beteende
- Tecken och symtom
- Hemiska och lymfsjukdomar
- Leukemi
- Prekursorcellslymfoblastisk leukemi-lymfom
- Viktökning
- Motorisk aktivitet
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Utöva
Andra studie-ID-nummer
- LCCC2541
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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