Evaluering av en intervensjon for sosialt nettverk for å redusere kreftrelatert nød
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Faktiske)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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California
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Loma Linda, California, Forente stater, 92350
- Loma Linda University
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inklusjonskriterier:
- minst 18 år,
- tidligere kreftdiagnose annet enn ikke-melanom hudkreft,
4) flytende engelsk, 5) rutinemessig tilgang til Internett, og 6) tilstedeværelse av større enn mild nød som identifisert ved å ha nød større enn eller lik 4 ved innledende screening med nødtermometeret
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
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Aktiv komparator: Intervensjon for sosiale nettverk
Personer som er interessert i å delta i studien vil bli randomisert for å få tilgang til en 12-ukers internettbasert behandlingsgruppe.
Emner som tildeles behandlingsgruppen vil ha tilgang til en gruppediskusjonstavle, et strukturert 12-ukers kurs i mestringsferdigheter, faglig tilrettelegging av gruppen, en chattavle i sanntid og personlige profiler etablert av andre gruppemedlemmer.
Forsøkspersonene vil bli bedt om å fullføre online selvrapporteringsmål for nød, humørforstyrrelser og livskvalitet ved baseline og igjen etter deltagelse i 12-ukersgruppen.
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Aktiv komparator: Kontrollgruppe
12 ukers ventelistekontrollemner vil kunne bli med i en gruppe etter at de har fullført 12-ukers vurdering og vil bli bedt om å fullføre en 24-ukers vurdering for å måle endring over tid.
Deltakerne vil ha tilgang til en gruppediskusjonstavle, et strukturert 12-ukers kurs i mestringsferdigheter, faglig tilrettelegging av gruppen, en chattavle i sanntid og personlige profiler etablert av andre gruppemedlemmer.
Forsøkspersonene vil bli bedt om å fullføre online selvrapporteringsmål for nød, humørforstyrrelser og livskvalitet ved baseline og igjen etter deltagelse i 12-ukersgruppen.
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Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Endring i -Generell psykologisk funksjon (OQ-45)
Tidsramme: 3 måneders endring
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OQ-45 måler den globale funksjonen til en klient og er sammensatt av 3 underskalaer som måler subjektivt ubehag (intrapsykisk funksjon), mellommenneskelige forhold og sosial rolleytelse.
OQ-45 har tilstrekkelig intern konsistens (a = 0,93)
og pålitelighet (r = .84)
(Lambert, et al., 2004).
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3 måneders endring
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Endre skalaen i Center for Epidemiologic Studies Depress (CES-D).
Tidsramme: 3 måneders endring
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CES-D er et selvrapporteringsmål som består av 20 elementer vurdert på en 4-punkts Likert-skala for å vurdere depressive symptomer opplevd i forrige uke.
CES-D har vist utmerket pålitelighet og validitet (Radloff, 1977).
Standard cutoff score på 16 vil bli brukt for å identifisere depresjon.
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3 måneders endring
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Angst
Tidsramme: 3 måneders endring
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Angst-underskala av den korte Profile of Mood States (b-POMS; Shacham, 1983), som bruker 37 beskrivende stemningsadjektiver for å beskrive hvordan en deltaker følte seg den siste uken på en 5-punkts Likert-skala.
Se spesielt på angst (anx-underskala av POMS), vigor (underskala av POMS) og fatigue (underskala av POMS).
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3 måneders endring
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Utmattelse
Tidsramme: 3 måneders endring
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Fatigue-underskala av spørreskjemaet Profile of Mood States
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3 måneders endring
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Vigør
Tidsramme: 3 måneders endring
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Vigor-underskala av spørreskjemaet Profile of Mood States.
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3 måneders endring
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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Samarbeidspartnere
Samarbeidspartnere
Etterforskere
Etterforskere
- Hovedetterforsker: Jason E Owen, PhD, Loma Linda University
Publikasjoner og nyttige lenker
Generelle publikasjoner
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- Gustafson DH, Hawkins RP, Boberg EW, McTavish F, Owens B, Wise M, Berhe H, Pingree S. CHESS: 10 years of research and development in consumer health informatics for broad populations, including the underserved. Int J Med Inform. 2002 Nov 12;65(3):169-77. doi: 10.1016/s1386-5056(02)00048-5.
- Hartoonian N, Ormseth S, Bantum EO, Owen JE. (2008). Process and outcome evaluation of a social- networking website for health promotion. Ann Behav Med, 35s, 63.
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- Lieberman MA, Golant M, Giese-Davis J, Winzlenberg A, Benjamin H, Humphreys K, Kronenwetter C, Russo S, Spiegel D. Electronic support groups for breast carcinoma: a clinical trial of effectiveness. Cancer. 2003 Feb 15;97(4):920-5. doi: 10.1002/cncr.11145.
- Liess A, Simon W, Yutsis M, Owen JE, Piemme KA, Golant M, Giese-Davis J. Detecting emotional expression in face-to-face and online breast cancer support groups. J Consult Clin Psychol. 2008 Jun;76(3):517-23. doi: 10.1037/0022-006X.76.3.517.
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- Owen JE, O'Carroll Bantum E, Pagano IS, Stanton A. Randomized Trial of a Social Networking Intervention for Cancer-Related Distress. Ann Behav Med. 2017 Oct;51(5):661-672. doi: 10.1007/s12160-017-9890-4.
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