Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Collaborative Network to Take Responsibility for Oral Anticancer Therapy (CONTACT)

15. April 2019 aktualisiert von: Lise-Marie Kinnaer, KU Leuven

CONTACT: A Prospective Interventional Multicentre Before-after Study for the Implementation of a Care Pathway to Increase Self-management of Patients With Cancer Who Are Treated With Oral Anticancer Medications

This study aims to develop, implement and evaluate a care pathway for patients with cancer who are treated with oral anticancer drugs (OACD).

The care pathway will be developed in six hospitals in Flanders, and will be adapted to the local setting and situation.

The investigators hypothesize that the implementation of a care pathway will increase the quality of the drug therapy, the communication between health care professionals (HCPs) and patients, and will lead to an improved level of self-management and adherence. Moreover, the invesitgators hypothesize that the care pathway will facilitate the communication between HCPs in the hospital setting and in ambulatory care, and will improve counseling skills, self-efficacy and self-confidence of HCPs.

At the end of the study, a roadmap for the nation-wide implementation of a similar care pathway will be constructed based on the experiences of the participating hospitals. This roadmap will certainly include an e-learning platform for healthcare professionals.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

For each hospital, an individual care pathway will be developed following the 7-phase model by Vanhaecht et al., 2011. This methodology aims to offer a systematic approach in 7 phases for the support of an interdisciplinary team in the development of new care pathways or in the improvement of existing ones.

The before-part of the study includes phases 1 to 4 that aim to map current practice in detail and to translate these findings into the development of a care pathway. Current practice will be investigated using mixed methods comprising:

  • surveys evaluating care on the level of the hospital
  • semi-structured interviews with healthcare professionals (HCP) and patients
  • outcome assessments in patients included in the study (self-management, adherence, satisfaction with care, satisfaction with information, quality of life) using validated questionnaires at the start of the therapy, after 1 month and after three months
  • outcome assessments in healthcare professionals at baseline (self-efficacy and perceptions on self-management) using validated questionnaires
  • training and feedback sessions on counseling for HCPs

Based upon these findings, a care pathway in each hospital will be developed by a local project team of different stakeholders from different disciplines.

The after-part of the study includes phase 5-7 in which the care pathway is implemented, evaluated and continuously followed up.

Implementation and evaluation take place at the same time. The evaluation includes:

  • outcome assessments in patients (newly recruited) at the start of the therapy, after 1 month and after three months
  • outcome assessments in HCPs (follow up)
  • evaluation of counseling skills
  • focus group discussions and interviews with HCPs to evaluate the development and implementation of the care pathway.

At the end of the study a comparison of outcomes before and after the implementation will be made to study the impact of the care pathway on the before mentioned aspects (see "Brief Summary").

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

228

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
    • Antwerpen
      • Turnhout, Antwerpen, Belgien, 2300
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgien, 9000
    • Vlaams-Brabant
      • Bonheiden, Vlaams-Brabant, Belgien, 2820
    • West-Vlaanderen

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • a hematological cancer of solid tumor
  • starting an oral anticancer drug for the first time
  • able to understand and speak Dutch

Exclusion Criteria:

  • patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
  • patients following a therapy with a study drug

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Non-care pathway

This arm comprises patients before the implementation of the care pathway. Patients starting with an oral anticancer therapy participate in the current care process. Outcomes are assessed at start of treatment, after 1 and after 3 months.

The decision to start with an oral anticancer therapy depends solely on the treating physician.
Experimental: Care Pathway

This arm comprises patients after the implementation of the care pathway. Patients starting with an oral anticancer therapy in this arm, receive care as is described by the novel designed care pathway. Outcomes are again assessed at start of treatment, after 1 and after 3 months.

The decision to start with an oral anticancer therapy depends solely on the treating physician.
Sonstiges: Implementation of a care pathway
The care pathway will consist of procedures of care in the hospital (e.g. consultations with doctors, contact moments with nurses, ...) that describe the initiation of an oral anticancer therapy and the further follow up. The care pathway should describe how care can efficiently be organised.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in self-management skills
Zeitfenster: at the start of the therapy, after one and three months

There is no gold standard to define self-management. A definition from Barlow et al., 2002 (2) defines self-management as follows: the ability of an individual to manage the symptoms, treatment, physical and psychosocial consequences and life style changes due to his/her condition. Adequate self-management refers to the ability to monitor one's condition and to effect cognitive, behavioural and emotional responses necessary to maintain a satisfactory quality of life.

The studied self-management skills in this project comprise "social integration and support", "health service navigation", "constructive attitudes and approaches", "skill and technique acquisition" and "emotional distress".
at the start of the therapy, after one and three months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in medication Adherence
Zeitfenster: after one and three months of therapy
after one and three months of therapy
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Zeitfenster: after one and three months
after one and three months
Change in patient satisfaction with care using Out-patsat 35
Zeitfenster: at the start of the therapy, after one and three months
The outpatsat is a questionnaire for ambulatory cancer patients in which they are asked to rate in different subscales their perceptions on care delivered by doctors, nurses and rate te overall organisation (accessibility of the hospital, ease of reaching the hospital by telephone, ...) during their stay at day hospital of consultations
at the start of the therapy, after one and three months
Health Related Quality of Life
Zeitfenster: at the start of the therapy, after one and three months
at the start of the therapy, after one and three months
Change in Distress using the Distress Barometer
Zeitfenster: at the start of the therapy, after one and three months
at the start of the therapy, after one and three months
Efficacy of treatment Using ECOG performance scale and RECIST criteria
Zeitfenster: at the start of the therapy, after one and three months
at the start of the therapy, after one and three months
Toxicity of treatment
Zeitfenster: at the start of the therapy, after one and three months
Summarizing adverse drug events
at the start of the therapy, after one and three months
Cost of care
Zeitfenster: at the start of the therapy, after one and three months
Prospective report on health care expenditures (use of healthcare and other services, use of medicines, …)
at the start of the therapy, after one and three months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS)
Zeitfenster: at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
SEPSS investigates the ability of a HCP to evaluate their own performance in daily practice and caregiving.
at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
Change in perceptions on self-management in HCPs using the Clinician Support for Patient activation measure
Zeitfenster: at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
at baseline (before the implementation of the care pathway) and after 24 months (during implementation)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

KU Leuven

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2015

Primärer Abschluss (Voraussichtlich)

1. November 2022

Studienabschluss (Voraussichtlich)

1. November 2022

Studienanmeldedaten

Zuerst eingereicht

2. August 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. August 2016

Zuerst gepostet (Schätzen)

10. August 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • LMK15022016

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Implementation of a care pathway

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Egypt

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren