Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia (PAQOL)
16. november 2015 opdateret af: St. Jude Children's Research Hospital
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial
This will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- <19 years) with newly diagnosed ALL.
It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL).
The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL.
This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
An advanced practice nurse (APN) will meet twice weekly with the patient and family for the first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic interaction; this will be followed by once weekly visits during weeks 5-8 of the intervention; and monthly visits during weeks 9-through end of therapy.
The physical therapist (PT) will meet at least once weekly with the patient and family during weeks 1-4 to initiate the prescriptive tailored exercise program; subsequent visits to reinforce and modify the program will occur at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135 of the intervention.
The PT will visit at least once weekly during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135.
During weeks 9-135 of the intervention, the APN will call between the monthly in person-visits, if needed to those randomized to the MAP group to assure fidelity to the intervention and to provide booster support to the intervention where needed.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
122
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- Toronto Hospital for Sick Children
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- AFLAC Cancer Center Children's Healthcare of Atlanta
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, Forenede Stater, 77030
- MD Anderson
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- An immunophenotypic diagnosis of non-B cell ALL
- Age 4 years through <19 years at diagnosis
- 2-8 days on or per front line ALL treatment protocol
- One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language
- Participant speaks and understands the English language
- Written informed consent and child assent
Exclusion Criteria:
- Age < 4 years or ≥19 years at diagnosis
- A diagnosis of cerebral palsy or down syndrome
- Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent
- Females who are pregnant.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Fysisk terapi
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Each patient in this group will have physical therapy performed.
The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL.
Andre navne:
Visits with an Advanced Practice Nurse to support sustained motivation.
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Ingen indgriben: Minimal movement
Minimal movement group with usual care non-intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Bone Mineral Density/Bone Mineral Content
Tidsramme: Assessed at baseline and at completion of therapy
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Assessed at baseline and at completion of therapy
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Health- related quality of life
Tidsramme: Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy
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Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cheryl L Cox, RN, PhD, St. Jude Children's Research Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2009
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
13. maj 2009
Først indsendt, der opfyldte QC-kriterier
14. maj 2009
Først opslået (Skøn)
15. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PAQOL
- R01CA129384 (U.S. NIH-bevilling/kontrakt)
- NCI-2012-00017 (Registry Identifier: NCI Clinical Trial Registraiton Program)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .