Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy (PSP)
16 oktober 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
281
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Vejle, Danmark, 7100
- Department of Oncology, Vejle Hospital, Region of Southern Denmark
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: usual care
Usual care.
The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Shared Care questionnaire
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Illness Intrusiveness Rating Scale (IIRS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2016
Primärt slutförande (Faktisk)
1 augusti 2020
Avslutad studie (Faktisk)
1 augusti 2020
Studieregistreringsdatum
Först inskickad
3 mars 2016
Först inskickad som uppfyllde QC-kriterierna
22 mars 2016
Första postat (Uppskatta)
23 mars 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Partnership-Project
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