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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jessica Buddenbaum, MS
- Telefonnummer: 919-966-4432
- E-post: jessica_buddenbaum@med.unc.edu
Studer Kontakt Backup
- Navn: Juanita Cuffee
- Telefonnummer: 919-216-0463
- E-post: cuffee@med.unc.edu
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
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Ta kontakt med:
- Juanita Cuffee
- Telefonnummer: 919-966-0017
- E-post: cuffee@med.unc.edu
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Ta kontakt med:
- Jessica Buddenbaum, MS
- E-post: jessica_buddenbaum@med.unc.edu
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Hovedetterforsker:
- Thomas Alexander, MD, MPH
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of subjects completed exercise intervention
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Ability to capture weekly functional activity
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Thomas Alexander, MD, MPH, UNC Lineberger Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Kroppsvekt
- Sykdommer i immunsystemet
- Endringer i kroppsvekt
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukemi, lymfoid
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Hemic og lymfatiske sykdommer
- Leukemi
- Forløpercelle lymfoblastisk leukemi-lymfom
- Vektøkning
- Motorisk aktivitet
- Motorisk aktivitet
- Bevegelse
- Muskel- og skjelettfysiologiske fenomener
- Muskel- og skjelett og nevrale fysiologiske fenomener
- Øvelse
Andre studie-ID-numre
- LCCC2541
Plan for individuelle deltakerdata (IPD)
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