Familielivsstil, handlinger og risikouddannelsesintervention: Version 2 (FLARE)
FLARE-indsatsen til forebyggelse af hudkræft til børn af melanomoverlevere
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Tilmelding
Når forældre-barn-dyader har gennemført screening og informeret samtykke/samtykkeprocedurer, vil deltagerne blive inviteret til at gennemføre en online baseline-vurdering. Efter baseline-vurderingen vil dyader blive randomiseret til at modtage enten FLARE-interventionen eller standarduddannelse. Efter randomisering vil hver dyade modtage et unikt log-in på en sikker undersøgelseshjemmeside, der vil blive brugt til at gennemgå didaktisk materiale forud for hver interventionssession.
Interventionssessioner
Dyads vil mødes med en interventionist via fjernleveret live-session til deres tre interventionssessioner. Interventionssessioner vil blive planlagt hver anden uge. Efter afslutningen af den sidste fjernafleverede session vil alle forældre modtage kvartalsvise boosterbeskeder via sms eller e-mail.
Studievurderinger
Dyads vil blive bedt om at gennemføre online vurderinger, efter at samtykke er givet (baseline) og inden for de 4 dage før session 3. En første post-intervention vurdering vil finde sted 4 uger efter den sidste interventionssession er afholdt. En anden post-interventionsvurdering vil finde sted 4 uger senere. Den langsigtede opfølgningsvurdering vil finde sted 1 år efter baseline. Hver vurdering forventes at tage 15-30 minutter. Forældre vil også modtage en kort vurdering via sms eller e-mail (afhængigt af forældrenes præference) med månedlige intervaller mellem den anden post-evaluering og den 1-årige post-baseline-vurdering og i sommermånederne umiddelbart efter 1-års post-baseline. vurdering. Alle vurderinger vil blive gennemført elektronisk.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
Voksne er berettiget til denne prøve, hvis de:
- Er mindst 18 år OG
- Er blevet diagnosticeret med melanom på ethvert tidspunkt i deres liv OG
- Har mindst ét biologisk barn i alderen 8-17 år, som kan deltage i forsøget med dem.
Børn er berettiget til at deltage sammen med deres forælder, hvis de:
- Er i alderen 8-17 år OG
- Havde mindst 1 solskoldning inden for de sidste 12 måneder OG
- Har mindst én biologisk forælder med en historie med melanom, som kan deltage i forsøget med dem.
Ekskluderingskriterier:
Voksne og børn vil blive udelukket fra deltagelse, hvis de:
- Tal ikke engelsk ELLER
- Er ude af stand til at deltage på grund af udviklingsforsinkelse ELLER
- Modtog test for en mutation i CDKN2A/p16, inklusive dem, der deltog i et tidligere studie, hvor de modtog information om CDKN2A/p16.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: FLARE Intervention
Deltagerne vil blive randomiseret til at modtage en intervention, der arbejder med melanomoverlevere og deres børn som en familieenhed for at forbedre melanomforebyggende adfærd.
|
[Se arm-/gruppebeskrivelser]
|
|
Ingen indgriben: Standard uddannelse
Deltagerne vil blive randomiseret til at modtage information om børns solbeskyttelse, som er offentligt tilgængelig.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome. |
Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/Standard deviation of skin tone at all timepoints.
Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.
|
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
|
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/standard deviation of sunscreen application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you use sunscreen with an SPF of 30+?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
|
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/standard deviation of sunscreen re-application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
|
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/standard deviation of long sleeved shirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
|
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/standard deviation of long pants/skirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
|
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/standard deviation of shade occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
|
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Tidsramme: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Mean/standard deviation of avoidance of peak hours at all timepoints. "These next questions ask about what you have done in the past (time frame) if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yelena Wu, PhD, University of Utah
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB_00114901
- 133811-RSG-19-121-01-CPPB (Andet bevillings-/finansieringsnummer: American Cancer Society, Inc.)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Melanom
-
National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
-
National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
-
Sidney Kimmel Comprehensive Cancer Center at Thomas...PfizerAktiv, ikke rekrutterendeCiliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært melanom | Stadie IIIC Intraokulært melanom | Stadie I Intraokulært melanom | Stadie IIA Intraokulært melanom | Stadie IIB... og andre forholdForenede Stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Okulært melanom | Fase IIIC kutan melanom AJCC v7 | Kutant melanom | Slimhinde melanom | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7 | Stadie III Akral Lentiginøst Melanom AJCC... og andre forholdForenede Stater
-
The Netherlands Cancer InstituteRekrutteringHjerne metastaser fra brystkræft | Hjernemetastaser fra ikke-småcellet lungekræft (NSCLC) | Hjerne metastaser fra melanomaHolland
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
-
National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
-
National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
Kliniske forsøg med FLARE Intervention
-
The Second Affiliated Hospital of Chongqing Medical...RekrutteringStråling Pneumonitis | Strålingsinduceret lungeskade | Lungekræft (herunder metastatisk kræft)Kina
-
Biolux Research Holdings, Inc.AfsluttetOrtodontisk tandbevægelseCanada
-
University of FloridaAfsluttetFølsomhedForenede Stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekrutteringBiokemisk tilbagevendende prostatakarcinom | Fase IV prostatakræft AJCC v8 | Stage IVA prostatakræft AJCC v8 | Stadie IVB prostatakræft AJCC v8 | Metastatisk prostataadenokarcinomForenede Stater
-
University of WashingtonNational Cancer Institute (NCI)AfsluttetAvanceret malignt neoplasmaForenede Stater
-
Roswell Park Cancer InstituteAfsluttetFedme | Overvægtig | Anatomisk fase I brystkræft AJCC v8 | Anatomisk fase IA brystkræft AJCC v8 | Anatomisk fase IB brystkræft AJCC v8 | Anatomisk fase II brystkræft AJCC v8 | Anatomisk fase IIA brystkræft AJCC v8 | Anatomisk fase IIB brystkræft AJCC v8 | Anatomisk fase III brystkræft AJCC v8 | Anatomisk fase... og andre forholdForenede Stater
-
Universidad de ExtremaduraDiputación Provincial de BadajozRekrutteringSundhedsuddannelse | Gamification in Health EducationSpanien
-
City of Hope Medical CenterNational Cancer Institute (NCI)AfsluttetBrystkarcinom | Lungekarcinom | Kolorektalt karcinom | Ondartet neoplasma | Blærekarcinom | Malignt kvindeligt reproduktionssystem neoplasmaForenede Stater
-
Mayo ClinicAfsluttet
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityAfsluttetOndartet neoplasmaForenede Stater