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Outcomes of Triaged Family Care in Advanced Cancer (FOCUS-Triage)

10. februar 2014 opdateret af: University of Michigan
The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to:

  1. determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care
  2. determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low).

A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

484

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University Of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • St. Joseph Mercy Cancer Center
      • Detroit, Michigan, Forenede Stater, 48202
        • Wayne State University
      • Detroit, Michigan, Forenede Stater, 48202
        • Karmanos Cancer Center
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital Cancer Institute

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

Inclusion Criteria:

  • Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
  • Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
  • For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
  • Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.

Exclusion Criteria:

  • Patients will be excluded if they have multiple primary cancer sites.
  • Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Brief
Dyads randomized to BRIEF arm received the Brief FOCUS Program (two home visits and one phone call by a trained nurse) in addition to standard clinical care.
Adfærdsmæssigt: Brief FOCUS Program
Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.
Andre navne:
  • Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S)
  • Family-based Intervention
  • Cancer Patient and Family Member Intervention
Eksperimentel: Extensive
Dyads randomized to EXTENSIVE arm received the Extensive FOCUS Program (4 home visits and two phone calls by a trained nurse) in addition to standard clinical care.
Adfærdsmæssigt: Extensive FOCUS Program
Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.
Andre navne:
  • Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S)
  • Family-based Intervention
  • Cancer Patient and Family Member Intervention
Ingen indgriben: Control
Dyads randomized to CONTROL arm continued with standard clinical care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in Quality of Life
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Risk for Distress
Tidsramme: Baseline
Baseline
Change in Emotional Distress
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Appraisal of Illness/Caregiving
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Uncertainty
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Hopelessness
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Self-efficacy
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Benefits of Illness
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Family Communication
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Support
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Depression
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Coping
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Health Care Resource Utilization
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change in Caregiver Burden
Tidsramme: Baseline, 3 and 6 months
Baseline, 3 and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

National Cancer Institute (NCI)
Wayne State University

Efterforskere

  • Ledende efterforsker: Laurel L Northouse, PhD, RN, University of Michigan

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

Hjælpsomme links

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

1. juni 2005

Primær færdiggørelse (Faktiske)

1. maj 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

1. juli 2008

Først indsendt, der opfyldte QC-kriterier

2. juli 2008

Først opslået (Skøn)

3. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2014

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01CA107383 (U.S. NIH-bevilling/kontrakt)
  • UMCC 2003-094 (Anden identifikator: University of Michigan)
  • IRBMED No. 2004-0129 (Anden identifikator: University of Michigan)

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 .

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