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

15 april 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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").

Studietype

Ingrijpend

Inschrijving (Verwacht)

228

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in self-management skills
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in medication Adherence
Tijdsspanne: 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)
Tijdsspanne: after one and three months
after one and three months
Change in patient satisfaction with care using Out-patsat 35
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

KU Leuven

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2015

Primaire voltooiing (Verwacht)

1 november 2022

Studie voltooiing (Verwacht)

1 november 2022

Studieregistratiedata

Eerst ingediend

2 augustus 2016

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2016

Eerst geplaatst (Schatting)

10 augustus 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 april 2019

Laatste update ingediend die voldeed aan QC-criteria

15 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LMK15022016

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

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