Improvement of Information to Cancer Patients' Caregivers
18. januar 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
211
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Herlev, Danmark, 2730
- Department of Oncology, Herlev Hospital
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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
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Immediate intervention
Immediately after enrollment in the project, caregivers and patients receive the intervention
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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
|
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Annen: Delayed intervention (3 weeks later)
This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
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Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24
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Change from baseline (enrollment) at 2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with communication with health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
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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"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
Tidsramme: Change from baseline (enrollment) at 2 weeks
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Measures: CaTCoN subscale "Need for help from health care professionals"
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Change from baseline (enrollment) at 2 weeks
|
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Anxiety and depression
Tidsramme: Change from baseline (enrollment) at 2 weeks
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Measure: The Hospital Anxiety and Depression Scale (HADS)
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Change from baseline (enrollment) at 2 weeks
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Fulfillment of needs
Tidsramme: Change from baseline (enrollment) at 2 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 2 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The time spent on information as reported by health care professionals
Tidsramme: Weeks 0-6 from baseline
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Investigated in focus group interviews with the health care professionals
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Weeks 0-6 from baseline
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Satisfaction with information from health care professionals
Tidsramme: Change from baseline (enrollment) at 12 weeks
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Measure: CaTCoN item 24
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
- Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29.
- Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8.
- Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16.
- Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.
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 2015
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. august 2016
Datoer for studieregistrering
Først innsendt
29. januar 2015
Først innsendt som oppfylte QC-kriteriene
2. mars 2015
Først lagt ut (Anslag)
5. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- R82-A5445
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. .