- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02716168
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy (PSP)
16. oktober 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
281
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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Vejle, Danmark, 7100
- Department of Oncology, Vejle Hospital, Region of Southern Denmark
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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
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
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 inngripen: usual care
Usual care.
The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
- 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.
Hjelpsomme linker
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 (Faktiske)
1. mai 2016
Primær fullføring (Faktiske)
1. august 2020
Studiet fullført (Faktiske)
1. august 2020
Datoer for studieregistrering
Først innsendt
3. mars 2016
Først innsendt som oppfylte QC-kriteriene
22. mars 2016
Først lagt ut (Anslag)
23. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Partnership-Project
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