Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Internet Based Screening and Stepped Care for Cancer Patients With Anxiety and Depression Symptoms (AdultCan)

15. februar 2017 oppdatert av: Uppsala University

Uppsala University Psychosocial Care Programme: Internet Based Screening and Stepped Care for Adult Cancer Patients With Anxiety and Depression Symptoms - A Randomized Controlled Trial

The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and health related quality of life in cancer patients with anxiety and depression symptoms, compared to Standard Care, and to evaluate the health-economic effects of the intervention. The investigators also want to examine the development of anxiety and depression symptoms and health related quality of life in cancer patients without initial symptoms.

The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC). Secondary hypotheses are that less anxiety and depression symptoms also means improved health related quality of life and that I SC is cost-effective or at least cost neutral compared to standard care.

The IT-platform Carebase.se is developed within U-CARE. The platform will be used for delivering of interventions and for collection of all patient reported outcomes. Patients with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms will be included in descriptive studies. All patients, in the randomized controlled trial and the descriptive study will followed up during 24 months

I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2). Step 1 starts directly after randomization and extends over a 24 months period. Step one comprises web-based patient education including psycho-education and easy interventions strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to other experts in the project group for advices about how to answer patients' questions.

Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for common psychological concerns. The participants' chooses to work with modules that correspond to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and include conventional treatment methods with homework and weekly contacts with the psychologist. Step 2 extends over a 10-week period.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

229

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
    • Gävleborg
      • Gävle, Gävleborg, Sverige, 80187
        • The hospital i Gävle
    • Uppland
      • Uppsala, Uppland, Sverige, 75105
        • Uppsala University Hospital
    • Västmanland
      • Västerås, Västmanland, Sverige, 72189
        • Västmanlands Hospital Västerås

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Newly diagnosed Breast- Colorectal- or Prostate cancer or recurrent Colorectal cancer within 3 months form diagnoses

Exclusion Criteria:

  • inability to communicate in Swedish
  • Karnovsky performance status < 40
  • short expected survival (< 6 month)
  • cognitive disability (e.g. dementia or psychosis)
  • severe depression or suicide risk

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: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Standard omsorg
Eksperimentell: Internet-based stepped care
Internet-based stepped care comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2). Step 1 starts directly after randomization and extends over a 24 months period. Step 2 extends to a period of ten weeks.
Atferdsmessig: Internet-based stepped care
Interactive support and Cognitive Behavioral Therapy
Andre navn:
  • Internett-basert CBT
  • Self-help program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in depression
Tidsramme: From baseline and 10 months later (after intervention)

Hospital Anxiety and Depression Scale (HADS) - depression subscale. Range 0-21, >7 is defined as doubtful cases and >10 is defined as clinical cases.

Montgomery Åsberg Depression Rating Scale (MADRS). Range 0-60 points, >30 is defined as severe depression, >3 at question nr. 9 is defined as suicide risk.
From baseline and 10 months later (after intervention)
Change in anxiety
Tidsramme: From baseline and 10 months later (after intervention)

Hospital Anxiety and Depression Scale (HADS) - anxiety subscale. Range 0-21, >7 is defined as doubtful cases and >10 is defined as clinical cases.

Spielberger State-Trait Anxiety Inventory State subscale (STAI-S). Range 20-80.
From baseline and 10 months later (after intervention)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in health related quality of life
Tidsramme: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), the Breast Cancer module (QLQ-BR23), the Colorectal Cancer module (QLQ-CR29) and the Prostate Cancer module (QLQ-PR25).
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Change in Cancer related fatigue (CRF)
Tidsramme: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Change in insomnia
Tidsramme: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Insomnia Severity Index (ISI)
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Change in posttraumatic stress
Tidsramme: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C)
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Uppsala University

Etterforskere

  • Studieleder: Louise von Essen, Professor, Uppsala University

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

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

1. april 2013

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

29. mai 2012

Først innsendt som oppfylte QC-kriteriene

26. juni 2012

Først lagt ut (Anslag)

28. juni 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • U-CARE AdultCan

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere