Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy (PSP)
16 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
281
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Vejle, Danemark, 7100
- Department of Oncology, Vejle Hospital, Region of Southern Denmark
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: usual care
Usual care.
The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Shared Care questionnaire
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Illness Intrusiveness Rating Scale (IIRS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2016
Achèvement primaire (Réel)
1 août 2020
Achèvement de l'étude (Réel)
1 août 2020
Dates d'inscription aux études
Première soumission
3 mars 2016
Première soumission répondant aux critères de contrôle qualité
22 mars 2016
Première publication (Estimation)
23 mars 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- Partnership-Project
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