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Improvement of Information to Cancer Patients' Caregivers

18. januar 2019 opdateret af: Mogens Groenvold, Bispebjerg Hospital

Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study

The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

211

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Herlev, Danmark, 2730
        • Department of Oncology, Herlev 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Patient Inclusion Criteria:

  • Cancer patient
  • Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
  • Written informed consent

Caregiver Inclusion Criteria:

  • Attends the first visit in the Department of Oncology with the patient
  • Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
  • Written informed consent

Exclusion Criteria:

  • Patient and/or caregiver do not understand Danish well enough to participate in the study
  • The patient has an expected survival of less than six months

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Immediate intervention
Immediately after enrollment in the project, caregivers and patients receive the intervention
Adfærdsmæssigt: Identification and provision of lacking information
The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
Andet: Delayed intervention (3 weeks later)
This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks
Adfærdsmæssigt: Identification and provision of lacking information
The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24
Change from baseline (enrollment) at 2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
Change from baseline (enrollment) at 2 weeks
Satisfaction with communication with health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
Change from baseline (enrollment) at 2 weeks
Satisfaction with support from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
Change from baseline (enrollment) at 2 weeks
Satisfaction with support from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measures: CaTCoN subscale "Need for help from health care professionals"
Change from baseline (enrollment) at 2 weeks
Anxiety and depression
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measure: The Hospital Anxiety and Depression Scale (HADS)
Change from baseline (enrollment) at 2 weeks
Fulfillment of needs
Tidsramme: Change from baseline (enrollment) at 2 weeks
Measure: Family Inventory of Needs (FIN)
Change from baseline (enrollment) at 2 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The time spent on information as reported by health care professionals
Tidsramme: Weeks 0-6 from baseline
Investigated in focus group interviews with the health care professionals
Weeks 0-6 from baseline
Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measure: CaTCoN item 24
Change from baseline (enrollment) at 12 weeks
Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
Change from baseline (enrollment) at 12 weeks
Satisfaction with communication with health care professionals
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
Change from baseline (enrollment) at 12 weeks
Satisfaction with support from health care professionals
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
Change from baseline (enrollment) at 12 weeks
Satisfaction with support from health care professionals
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measures: CaTCoN subscale "Need for help from health care professionals"
Change from baseline (enrollment) at 12 weeks
Anxiety and depression
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measure: The Hospital Anxiety and Depression Scale (HADS)
Change from baseline (enrollment) at 12 weeks
Fulfillment of needs
Tidsramme: Change from baseline (enrollment) at 12 weeks
Measure: Family Inventory of Needs (FIN)
Change from baseline (enrollment) at 12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Bispebjerg Hospital

Samarbejdspartnere

Danish Cancer Society
Herlev Hospital

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

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. april 2015

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

29. januar 2015

Først indsendt, der opfyldte QC-kriterier

2. marts 2015

Først opslået (Skøn)

5. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • R82-A5445

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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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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