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

15 aprile 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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").

Tipo di studio

Interventistico

Iscrizione (Anticipato)

228

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in self-management skills
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in medication Adherence
Lasso di tempo: 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)
Lasso di tempo: after one and three months
after one and three months
Change in patient satisfaction with care using Out-patsat 35
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS)
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

KU Leuven

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2015

Completamento primario (Anticipato)

1 novembre 2022

Completamento dello studio (Anticipato)

1 novembre 2022

Date di iscrizione allo studio

Primo inviato

2 agosto 2016

Primo inviato che soddisfa i criteri di controllo qualità

5 agosto 2016

Primo Inserito (Stima)

10 agosto 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LMK15022016

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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