Improvement of Information to Cancer Patients' Caregivers
18 janvier 2019 mis à jour par: Mogens Groenvold, Bispebjerg Hospital
Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study
The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
211
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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Herlev, Danemark, 2730
- Department of Oncology, Herlev Hospital
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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
Patient Inclusion Criteria:
- Cancer patient
- Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
- Written informed consent
Caregiver Inclusion Criteria:
- Attends the first visit in the Department of Oncology with the patient
- Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
- Written informed consent
Exclusion Criteria:
- Patient and/or caregiver do not understand Danish well enough to participate in the study
- The patient has an expected survival of less than six months
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Immediate intervention
Immediately after enrollment in the project, caregivers and patients receive the intervention
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The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
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Autre: Delayed intervention (3 weeks later)
This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks
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The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Satisfaction with information from health care professionals
Délai: Change from baseline (enrollment) at 2 weeks
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Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24
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Change from baseline (enrollment) at 2 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Satisfaction with information from health care professionals
Délai: Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with communication with health care professionals
Délai: Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
Délai: Change from baseline (enrollment) at 2 weeks
|
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
Délai: Change from baseline (enrollment) at 2 weeks
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Measures: CaTCoN subscale "Need for help from health care professionals"
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Change from baseline (enrollment) at 2 weeks
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Anxiety and depression
Délai: Change from baseline (enrollment) at 2 weeks
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Measure: The Hospital Anxiety and Depression Scale (HADS)
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Change from baseline (enrollment) at 2 weeks
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Fulfillment of needs
Délai: Change from baseline (enrollment) at 2 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 2 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The time spent on information as reported by health care professionals
Délai: Weeks 0-6 from baseline
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Investigated in focus group interviews with the health care professionals
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Weeks 0-6 from baseline
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Satisfaction with information from health care professionals
Délai: Change from baseline (enrollment) at 12 weeks
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Measure: CaTCoN item 24
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Change from baseline (enrollment) at 12 weeks
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|
Satisfaction with information from health care professionals
Délai: Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with communication with health care professionals
Délai: Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
Délai: Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
Délai: Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Need for help from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Anxiety and depression
Délai: Change from baseline (enrollment) at 12 weeks
|
Measure: The Hospital Anxiety and Depression Scale (HADS)
|
Change from baseline (enrollment) at 12 weeks
|
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Fulfillment of needs
Délai: Change from baseline (enrollment) at 12 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 12 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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
- Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29.
- Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8.
- Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16.
- Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.
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
1 avril 2015
Achèvement primaire (Réel)
1 mai 2016
Achèvement de l'étude (Réel)
1 août 2016
Dates d'inscription aux études
Première soumission
29 janvier 2015
Première soumission répondant aux critères de contrôle qualité
2 mars 2015
Première publication (Estimation)
5 mars 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 janvier 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 janvier 2019
Dernière vérification
1 janvier 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- R82-A5445
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .