Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy (PSP)
16. oktober 2020 opdateret af: Theis Trabjerg, University of Southern Denmark
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care.
The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients.
Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers.
Patients may feel uncertain about the health professionals' skills and area of responsibility.
Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment.
The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark.
Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners.
Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
281
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Vejle, Danmark, 7100
- Department of Oncology, Vejle Hospital, Region of Southern Denmark
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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:
- Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark
- Aged 18 years and over
- Able to speak and read Danish
- Mentally able to cooperate
- Listed with a general practitioner (98 % of the danish population)
- Written and verbal informed consent given
Exclusion Criteria:
- none
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Video consultation
Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment
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At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged.
The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.
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Ingen indgriben: usual care
Usual care.
The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Shared Care questionnaire
Tidsramme: 7 month after inclusion
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Patient reported outcome measure.
Cancer patients assessment of their cancer trajectory and their assessment of the cooperation between their General Practitioner and the oncologist specialist.
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7 month after inclusion
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Illness Intrusiveness Rating Scale (IIRS)
Tidsramme: 4 and 7 month after inclusion
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Patient reported outcome measure.
Patients assessment of the cancer disease influence on their daily living.
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4 and 7 month after inclusion
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European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)
Tidsramme: 4 and 7 month after inclusion
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Patient reported outcome measure.
Cancer patients assessment of their quality of life
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4 and 7 month after inclusion
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European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
Tidsramme: 4 and 7 month after inclusion
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4 and 7 month after inclusion
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Generalised Anxiety Disorder Assessment (GAD-7)
Tidsramme: 4 and 7 month after inclusion
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Patient reported outcome measure.
Screening tool and severity measure for generalised anxiety disorder
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4 and 7 month after inclusion
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Patient Health Questionnaire (PHQ-9)
Tidsramme: 4 and 7 month after inclusion
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Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.
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4 and 7 month after inclusion
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Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.
Tidsramme: Directly after the video consultation intervention
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It measures the oncologist perception of the benefits with the video consultation intervention.
Only the intervention group
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Directly after the video consultation intervention
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General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
Tidsramme: Directly after the video consultation intervention
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It measures the General Practitioners perception of the benefits with the video consultation intervention.
Only the intervention group.
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Directly after the video consultation intervention
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Patients assessment of a video consultation between the patient, General practitioner and oncologist.
Tidsramme: Directly after the video consultation intervention
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It measures the patients perception of the benefits with the video consultation intervention.Only the intervention group
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Directly after the video consultation intervention
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General Practitioner cancer trajectory assessment
Tidsramme: 4 month after the inclusion of the patient.
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The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.
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4 month after the inclusion of the patient.
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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.
Generelle publikationer
- Hansen DG, Trabjerg TB, Sisler JJ, Sondergaard J, Jensen LH. Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. BMJ Open. 2021 May 5;11(5):e043038. doi: 10.1136/bmjopen-2020-043038.
- Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Cross-sectoral video consultations in cancer care: perspectives of cancer patients, oncologists and general practitioners. Support Care Cancer. 2021 Jan;29(1):107-116. doi: 10.1007/s00520-020-05467-0. Epub 2020 Apr 21.
- Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Improving continuity by bringing the cancer patient, general practitioner and oncologist together in a shared video-based consultation - protocol for a randomised controlled trial. BMC Fam Pract. 2019 Jun 25;20(1):86. doi: 10.1186/s12875-019-0978-8.
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 (Faktiske)
1. maj 2016
Primær færdiggørelse (Faktiske)
1. august 2020
Studieafslutning (Faktiske)
1. august 2020
Datoer for studieregistrering
Først indsendt
3. marts 2016
Først indsendt, der opfyldte QC-kriterier
22. marts 2016
Først opslået (Skøn)
23. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Partnership-Project
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