Få sunne vaner til å holde seg (HABITS)
26. september 2025 oppdatert av: University of Tennessee
Få sunne vaner til å holde seg fast: Utvidede kontaktintervensjoner for å fremme langsiktig fysisk aktivitet hos afroamerikanske kreftoverlevere
Målet med dette prosjektet er å bidra til å øke vedlikeholdet av fysisk aktivitet hos kreftoverlevere som har større sannsynlighet for å oppleve helseforskjeller og sosiale ulemper.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
Hensikten med studien er å evaluere nye intervensjoner designet for å hjelpe kvinnelige kreftoverlevere, som identifiserer seg som afroamerikanere eller svarte, med å overvinne treningsbarrierer, utvikle en fysisk aktiv tankegang og etablere treningsvaner som trengs for å trene langsiktig.
Disse nye intervensjonene er 1.
Tekstmeldinger (SMS), 2. Peer Coaching, 3. Kombinasjon av Peer Coaching og SMS, 4. Vanlig omsorg
Studietype
Intervensjonell
Registrering (Antatt)
260
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Michelle Martin, PhD
- Telefonnummer: 901-448-2383
- E-post: mmart126@uthsc.edu
Studer Kontakt Backup
- Navn: Talia Williams, BA
- Telefonnummer: 901-448-8682
- E-post: twill213@uthsc.edu
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Rekruttering
- University of Alabama at Birmingham
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Ta kontakt med:
- Laura Rogers, MD, MPH
- Telefonnummer: 205-934-9735
- E-post: lqrogers@uabmc.edu
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Ta kontakt med:
- Ildiko Nyikos, MA, ACSM-RCEP, EIM-3
- Telefonnummer: 205-975-0002
- E-post: inyikos@uabmc.edu
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Hovedetterforsker:
- Laura Rogers, MD, MPH
-
-
Tennessee
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Memphis, Tennessee, Forente stater, 38163
- Rekruttering
- University of Tennessee Health Science Center
-
Ta kontakt med:
- Michelle Martin, PhD
- Telefonnummer: 901-448-2383
- E-post: mmart126@uthsc.edu
-
Ta kontakt med:
- Talia Williams, BA
- Telefonnummer: 901-448-8682
- E-post: twill213@uthsc.edu
-
Hovedetterforsker:
- Michelle Martin,, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inkluderingskriterier:
- kvinne på 19 år eller eldre
- identifiserer som afroamerikansk eller svart
- har en historie med kreft
- har fullført post-primær behandling for kreft (dvs. kjemoterapi, stråling)
- godta å la forskningsteamet bekrefte kreftdiagnosen med legen din
- Hvis det er operasjon, må det være minst 8 uker etter operasjonen
- villig til å la fastlege gi medisinsk godkjenning for studiedeltakelse
- villig til å oppgi hjemmeadresse hvis de er kvalifisert for studiet
- villig og i stand til å bruke videokonferanseplattform som Zoom til studieaktiviteter (må være både villig og kunne)
- villig og i stand til å sende og/eller motta tekstmeldinger (må være både villig og i stand til)
- har amerikansk telefonnummer
- har en e-postadresse
- hvis har ingen e-postadresse, må være villig til å opprette en
- engelsktalende
- Kan ambulere uten hjelp (trenger ikke bruke stokk, rullator eller rullestol)
- villige og i stand til å fullføre 3-5 treningsøkter per uke på egenhånd under studiets varighet; hvis du svarer nei, vennligst forklar
- villig til å delta på individuelle og gruppeøkter via videokonferanser under studiedeltakelse; hvis du svarer nei, vennligst forklar.
- villig til å delta på vurderinger via videokonferanse under studiedeltakelse; hvis du svarer nei, vennligst forklar.
- villig til å fullføre undersøkelser under studiedeltakelse; hvis du svarer nei, vennligst forklar.
Ekskluderingskriterier:
- Metastatisk eller tilbakevendende kreft
- en annen kreftdiagnose de siste 5 årene (ikke inkludert hud- eller livmorhalskreft in situ)
- har alvorlige ortopediske, ledd eller andre lidelser som hindrer personen i å være aktiv
- ustabil angina
- har maling, tetthet eller tyngde i brystet, ENTEN når du hviler ELLER deretter fysisk aktiv
- har New York Heart Association klasse II, III, OR IV kongestiv hjertesvikt
- blodtrykket har vært over 160/100 minst to ganger de siste 6 månedene (enten tall; 160 eller 100)
- har ukontrollert astma
- har interstitiell lungesykdom som krever ekstra oksygen
- har demens eller organisert hjernesyndrom
- har schizofreni eller aktiv psykose
- har hatt hjerneslag eller andre problemer som førte til individuelle funksjonshemninger eller lammelser (ikke i stand til å bevege seg eller føle noen del av kroppen)
- har hørselsproblemer som gjør det vanskelig å føre en telefonsamtale
- blind eller delvis blind
- planlagt operasjon i løpet av de første 6 månedene av studiedeltakelsen (hvis ikke godkjent av PI)
- planlagt kne- eller hofteoperasjon i løpet av de første 6 månedene av studiedeltakelsen
- forutse endringer i vanlige medisiner i løpet av de første 6 månedene av studiedeltakelse (hvis ikke godkjent av PI)
- har blitt fortalt av en lege å bare gjøre trening foreskrevet av en lege
- har blitt fortalt av en lege å begrense fysisk aktivitet
- har en kontraindikasjon for å delta i aerob trening med moderat intensitet
- har gjennomført i gjennomsnitt mer enn 90 minutter/uke med moderat intensitet eller mer enn 30 minutter/uke med kraftig trening de siste 6 månedene
- problemer med balanse eller å bevege seg trygt
- er gravid eller forventer gravid under studiedeltakelsen
- deltar for tiden i en annen treningsstudie
- har BMI ≥ 50
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Peer Coach og SMS
SMS og peer coach intervensjoner fokuserte på vedlikehold av fysisk aktivitet
|
Short Message System (SMS)-intervensjonen fokuserer på personlig tilpassede, adaptive SMS-meldinger som hjelper deltakeren å opprettholde fysisk aktivitetsatferd.
Peercoachen vil levere en intervensjon som vil hjelpe deltakerne til å opprettholde fysisk aktivitet.
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Eksperimentell: Peer Coach
Peer coach intervensjon fokusert på vedlikehold av fysisk aktivitet
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Peercoachen vil levere en intervensjon som vil hjelpe deltakerne til å opprettholde fysisk aktivitet.
Andre navn:
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Eksperimentell: Short Message Service (SMS)
SMS-intervensjon fokuserte på vedlikehold av fysisk aktivitet
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Short Message System (SMS)-intervensjonen fokuserer på personlig tilpassede, adaptive SMS-meldinger som hjelper deltakeren å opprettholde fysisk aktivitetsatferd.
Andre navn:
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Annen: Vanlig omsorg
Skriftlig materiell fokusert på vedlikehold av fysisk aktivitet
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Deltakerne vil få utdelt skriftlig materiale som gir råd om å opprettholde sin fysiske aktivitet.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fysisk aktivitet (pasientrapportert utfall)
Tidsramme: Fra baseline til 15 måneders vurdering
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Deltakerne vil bruke bevegelsessensor på midjen i 7 dager
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Fra baseline til 15 måneders vurdering
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fatigue (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Fatigue vil bli målt ved hjelp av Fatigue Symptom Inventory (tretthetsintensitet og interferens) skalaen.
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Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Selvopplevd helse (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Selvopplevd helse vil bli målt ved hjelp av EQ-5D spørreskjema.
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Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Kvalifiser livet (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Livskvalitet vil bli målt via spørreskjemaet PROMIS Global Health.
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Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Angst og depresjon (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Angst og depresjon vil bli målt ved hjelp av sykehusets angst- og depresjonskala.
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Ved baseline, 3 måneders vurdering, 9 måneders vurdering og 15 måneders vurdering.
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stress (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneder, 9 måneder og 15 måneder
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Stress vil bli målt ved hjelp av Perceived Stress Scale
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Ved baseline, 3 måneder, 9 måneder og 15 måneder
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Sosiale determinanter for helse
Tidsramme: Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Sosiale helsedeterminanter vil bli målt ved hjelp av spørreskjemaet Social Determinants of Health (SDoH).
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Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Big Five-personlighet (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Big Five personlighet vil bli målt ved hjelp av en kort versjon av Big Five Personality Inventory spørreskjema.
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Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Selvrapporter fysisk aktivitet
Tidsramme: Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Aerobic og motstandstrening vil bli målt ved hjelp av Godin Aerobic Strength spørreskjema.
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Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Livskvalitet (pasientrapportert utfall)
Tidsramme: Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Livskvalitet vil bli målt ved hjelp av spørreskjemaet EQ-5D-5L.
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Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Sosial støtte for fysisk aktivitet (pasientrapportert resultat)
Tidsramme: Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Sosial støtte til fysisk aktivitet vil bli målt ved hjelp av spørreskjemaet Sosial støtte til PA.
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Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Reflekterende, regulatoriske og refleksive prosesser (pasientrapportert utfall)
Tidsramme: Baseline, 3 måneder, 6 måneder, 9 måneder, 12 måneder, 15 måneder
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Reflekterende, regulatoriske og refleksive prosesser blir målt ved hjelp av spørreskjemaet M-PAC fysisk aktivitet.
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Baseline, 3 måneder, 6 måneder, 9 måneder, 12 måneder, 15 måneder
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Opplevd treningsbarrierer interferens
Tidsramme: Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Barrierer for trening vil bli målt ved å bruke spørreskjemaet Perceived Barriers to Exercise.
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Ved baseline, 3 måneder, 9 måneder, 15 måneder
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michelle Martin, PhD, University of Tennessee
- Hovedetterforsker: Laura Rogers, MD, MPH, University of Alabama at Birmingham
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. januar 2025
Primær fullføring (Antatt)
31. mars 2028
Studiet fullført (Antatt)
31. mars 2028
Datoer for studieregistrering
Først innsendt
17. desember 2024
Først innsendt som oppfylte QC-kriteriene
17. desember 2024
Først lagt ut (Faktiske)
20. desember 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Antatt)
1. oktober 2025
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. september 2025
Sist bekreftet
1. september 2025
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-300011855
- R01MD018375 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Personer som er interessert i å be om IPD bør kontakte studiens PI-er.
IPD-delingstidsramme
Etter at databehandlingen er fullført (og dataene er låst) og manuskriptet som rapporterer fysisk aktivitet vedlikeholdsdata ved måned 15 er sendt inn
Tilgangskriterier for IPD-deling
En databruksavtale mellom institusjonen som inneholder dataene (UTHSC) og institusjonen til den anmodende forskeren vil være nødvendig.
IPD-deling Støtteinformasjonstype
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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