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The Effect of Case Management in Complex Cancer Pathways

30. august 2012 opdateret af: University of Aarhus

Introduction: Case management (CM) has been proposed as a method for optimizing the course of treatment for complicated cancer patients. However evidence of the effect of CM is limited and methodologically rigorous research is needed.

Aim: To analyze effects of Nurse CM in complicated cancer care.

Methods: The study is designed as a two-arm randomized controlled trial (RCT) including approximately 280 colorectal cancer patients.

Intervention group patients will be offered usual medical treatment plus supportive intervention from a case manager. Control group patients will receive usual medical and supportive treatment.

The intervention: Case managers are registered nurses and possess thorough knowledge of cancer treatment and pathways. Core intervention elements: Planned and ad hoc personal and telephone contacts, surveillance of care pathways, coordination and dissemination of care plan (including transfer of patient-specific information to other departments and general practice).

Primary outcomes: Patient evaluations of care pathways and "Quality of Life" (questionnaires).

Secondary outcomes: Use of health care services and care process measures (The National Health Insurance Service Registry and The National Patient Registry; and GPs' evaluations of continuity of care (questionnaire).

Schedule:

  • "Case management used to optimize cancer care pathways: A systematic Review" has been published in BMC Health Services Research.
  • The CM manual has been written. Questionnaires are under development and pilot testing.
  • Two case managers have been appointed 1. January 2009.
  • After training and pilot testing of the intervention the RCT will begin in March 2009. Inclusion period is 12 months.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

280

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Aarhus C, Danmark, 8000
        • Department P, Aarhus University Hospital

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.

Exclusion Criteria:

  • Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Control
Control group patients will receive usual medical plus usual supportive treatment.
Aktiv komparator: Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Patient satisfaction with care pathways(questionnaire)
Tidsramme: 8, 30 and 52 weeks after inclusion and randomization
8, 30 and 52 weeks after inclusion and randomization
Quality of Life measures(questionnaire)
Tidsramme: 8, 30 and 52 weeks after inclusion and randomization
8, 30 and 52 weeks after inclusion and randomization

Sekundære resultatmål

Resultatmål
Tidsramme
Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
Tidsramme: 12 (and 6) months from diagnosis
12 (and 6) months from diagnosis
GPs' evaluations of continuity of care (questionnaire).
Tidsramme: 30 weeks after the patient's inclusion in the trial
30 weeks after the patient's inclusion in the trial
Care process measures in terms of monitoring of data from the National Patient Registry
Tidsramme: 12 (and 6) months after diagnosis
12 (and 6) months after diagnosis

Samarbejdspartnere og efterforskere

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

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.

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. marts 2009

Primær færdiggørelse (Faktiske)

1. januar 2011

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

13. februar 2009

Først indsendt, der opfyldte QC-kriterier

17. februar 2009

Først opslået (Skøn)

18. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. august 2012

Sidst verificeret

1. august 2012

Mere information

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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