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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

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

      • Vejle, Danmark, 7100
        • Department of Oncology, Vejle Hospital, Region of Southern Denmark

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
Eksperimentell: Video consultation
Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment
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.
Ingen inngripen: usual care
Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Shared Care questionnaire
Tidsramme: 7 month after inclusion
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.
7 month after inclusion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Illness Intrusiveness Rating Scale (IIRS)
Tidsramme: 4 and 7 month after inclusion
Patient reported outcome measure. Patients assessment of the cancer disease influence on their daily living.
4 and 7 month after inclusion
European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)
Tidsramme: 4 and 7 month after inclusion
Patient reported outcome measure. Cancer patients assessment of their quality of life
4 and 7 month after inclusion
European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
Tidsramme: 4 and 7 month after inclusion
4 and 7 month after inclusion
Generalised Anxiety Disorder Assessment (GAD-7)
Tidsramme: 4 and 7 month after inclusion
Patient reported outcome measure. Screening tool and severity measure for generalised anxiety disorder
4 and 7 month after inclusion
Patient Health Questionnaire (PHQ-9)
Tidsramme: 4 and 7 month after inclusion
Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.
4 and 7 month after inclusion
Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.
Tidsramme: Directly after the video consultation intervention
It measures the oncologist perception of the benefits with the video consultation intervention. Only the intervention group
Directly after the video consultation intervention
General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
Tidsramme: Directly after the video consultation intervention
It measures the General Practitioners perception of the benefits with the video consultation intervention. Only the intervention group.
Directly after the video consultation intervention
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
Directly after the video consultation intervention
General Practitioner cancer trajectory assessment
Tidsramme: 4 month after the inclusion of the patient.
The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.
4 month after the inclusion of the patient.

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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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

Andre studie-ID-numre

  • Partnership-Project

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