Reduktion af lungekræftrelateret angst (SLAP AF) (RELAX)
3. marts 2021 opdateret af: Wake Forest University Health Sciences
Formålet med denne forskningsundersøgelse er at sammenligne virkningerne af musik og forskellige niveauer af enhedsstyret vejrtrækning på angst og åndenød hos lungekræftoverlevere.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
MÅL
- At vurdere gennemførligheden (akkumulering, deltagelse, overholdelse, fastholdelse) af en randomiseret undersøgelse af enhedsstyret vejrtrækning og musik hos 75 efterbehandlingsoverlevere af lungekræft med betydelig angst.
- At opnå foreløbige data om variabiliteten og effektiviteten af to doser af en enhedsstyret åndedrætsintervention versus en musikkontrolgruppe til at reducere angst (primært resultat) og for at forbedre selvrapporteret dyspnø og respiratorisk funktion (sekundære resultater) i lunger efter behandling kræftoverlevere.
- For at vælge den optimale dosis af den enhedsstyrede åndedrætsintervention (15 minutter én gang/dag eller to gange/dag) til efterfølgende randomiseret undersøgelse.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
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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Delaware
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Rehoboth Beach, Delaware, Forenede Stater, 19971
- Beebe Health Campus
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Kansas
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas - Wichita
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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North Carolina
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Hendersonville, North Carolina, Forenede Stater, 28791
- Margaret R Pardee Memorial Hospital
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Prisma Health Greenville Memorial Hospital
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Center
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Tidligere historie om enhver lungekræft
- For stadium I-III sygdom bør patienter være 2-24 måneder efter afslutning af operation, strålebehandling og/eller kemoterapi uden yderligere planlagt behandling i løbet af 12-ugers undersøgelsen og uden tegn på sygdom.
- For sygdomsstadie IV modtager patienter muligvis ingen behandling eller modtager muligvis vedligeholdelsesbehandling med et målmiddel, kemoterapi eller immunterapi, forudsat at den seneste billeddiagnostik ikke viser progressiv sygdom.
- Efter udfyldelse af alle tre screeningsspørgeskemaer skal deltageren score tilsvarende på mindst ét spørgeskema for at være berettiget.
- Villig/i stand til at deltage i en kort introduktionssession og bruge den tildelte enhed i den tildelte periode (15 minutter en eller to gange om dagen), mindst 5 dage om ugen i 12 uger
- Alder ≥ 18 år
- Skal have telefon
Ekskluderingskriterier:
- Patienten forstår ikke engelsk
- Aktiv lungeinfektion
- Progressiv cancer (skal betragtes som ingen tegn på sygdom eller stabil)
- Enhver ændring i psykotrop medicin inden for de seneste 30 dage
- Høretab, der ville udelukke deltagelse i interventioner. Tilstrækkelig hørelse til at deltage vil blive afgjort via: (1) Svar på "nej" til spørgsmålet ["Har du et høreproblem nu?"] Deltagere med høreapparater vil få lov til at tilmelde sig, så længe deres hørelse er tilstrækkelig til at høre lydene på studieapparaterne. Hvis det er nødvendigt, vil potentielle undersøgelsesdeltagere modtage et kort testforsøg med RESPeRATE-enheden. Hvis de indikerer manglende evne til at høre de vejledende toner, vil de ikke blive tilmeldt undersøgelsen.
Kortisol udelukkelse
- Deltagere med endokrine lidelser (f.eks. diabetes og skjoldbruskkirtellidelser) eller på steroidbaseret medicin er udelukket fra kortisoldelen af undersøgelsen (med undtagelse af topisk hydrocortison, der er tilladt).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Gruppe A
Gruppe A - Udstyrsstyret vejrtrækning Lav dosis
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Gruppe A: 15 minutter en gang om dagen, 5 dage om ugen i 12 uger.
Andre navne:
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Eksperimentel: Gruppe B
Gruppe B - Apparatstyret vejrtrækning høj dosis
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Gruppe B - 15 minutter to gange om dagen, 5 dage om ugen i 12 uger.
Andre navne:
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Sham-komparator: Gruppe C
Gruppe C - Almindelig vejrtrækningskontrolgruppe
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Gruppe C - 15 minutter om dagen, 5 dage om ugen i 12 uger.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fastholdelse - Antal deltagere, der gennemfører den endelige vurdering
Tidsramme: 12 uger
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Fastholdelse vil blive beregnet som antallet af deltagere, der gennemfører den endelige vurdering divideret med antal randomiseret.
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12 uger
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Overholdelse - Mængden af tid, enheden bruges
Tidsramme: 12 uger
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Overholdelse vil blive beregnet som den faktiske tid, enheden bruges, divideret med den foreskrevne tid.
Succesfuld overholdelse vil blive defineret som brug af enheden ≥80 % af den tildelte tid.
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12 uger
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Accrual Rate- Antal patienter, der er tilfaldet undersøgelsen
Tidsramme: Tid fra studieåbning til studieafslutning ~46,42 måneder
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Optjeningsraten vil blive beregnet som antallet af patienter, der tilfalder undersøgelsen, divideret med antallet af måneder med optjening.
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Tid fra studieåbning til studieafslutning ~46,42 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring fra baseline for angst målt ved hospitalsangst og depressionsskala (HADS)
Tidsramme: 12 uger
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At opnå foreløbige data om variabiliteten og effektiviteten af to doser af en enhedsstyret åndedrætsintervention versus en sædvanlig vejrtrækningskontrolgruppe til at reducere angst.
Dette er en 14-elements selvrapporteringsmåling af kognitive og adfærdsmæssige symptomer på angst og depression; klinisk signifikante symptomer er angivet med en score på større end eller lig med 8 med et interval fra 0 til 42.
Højere score indikerer mere angst.
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12 uger
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spyt kortisol niveauer
Tidsramme: 12 uger
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Kortisolniveauer vil blive vurderet ved opvågning, 30 minutter efter opvågning og ved sengetid i tre på hinanden følgende dage ved baseline og tre på hinanden følgende dage.
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12 uger
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DNA-methyleringsniveauer
Tidsramme: 12 uger
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DNA-methyleringsniveauer vil blive målt for at bestemme, om ændringer i angst er forbundet med methylering
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12 uger
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Genekspressionsniveauer
Tidsramme: 12 uger
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DNA-methylerings- og genekspressionsmønstrene mellem de forskellige grupper.
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12 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Suzanne C Danhauer, PhD, Wake Forest University Health Sciences
- Ledende efterforsker: Glenn Lesser, MD, Wake Forest University Health Sciences
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.
Generelle publikationer
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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 (Faktiske)
30. juli 2015
Primær færdiggørelse (Faktiske)
23. december 2019
Studieafslutning (Faktiske)
23. december 2019
Datoer for studieregistrering
Først indsendt
27. januar 2014
Først indsendt, der opfyldte QC-kriterier
10. februar 2014
Først opslået (Skøn)
14. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00038743
- U10CA081851 (U.S. NIH-bevilling/kontrakt)
- WF-01213 (Anden identifikator: NCI)
- 1UG1CA189824 (U.S. NIH-bevilling/kontrakt)
- 2R25CA122061-07 (U.S. NIH-bevilling/kontrakt)
- R21CA182111-01 (U.S. NIH-bevilling/kontrakt)
- NCI-2014-02413 (Registry Identifier: NCI CTRP)
Plan for individuelle deltagerdata (IPD)
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