Collaborative Network to Take Responsibility for Oral Anticancer Therapy 2 — CONTACT-2  

Oncologic Disorders Clinical Trial

Official title: CONTACT-2: 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 Drugs

Status Not yet recruiting

Clinical Trial Summary

In 2015, the research team of KU Leuven and UGent started a pilot project supported by Kom op Tegen Kanker, called CONTACT-1. This multicentre before-after study aims at developing, implementing and evaluating a care pathway for patients treated with oral anticancer drugs (OACD) in four oncology centres in Flanders (AZ Groeninge Kortrijk, AZ Imelda Bonheiden, AZ Maria Middelares Gent, AZ Turnhout).

Preliminary results from CONTACT-1 have shown that re-organisation of care processes, and better interdisciplinary collaboration and communication, are highly needed, and that working towards a care pathway is an appropriate method to achieve this. However, the development and implementation of the care pathway in each hospital was difficult and needed intensive coaching by the research team. Moreover, we have currently no insight in the impact of the care pathway on defined outcomes, neither on the sustainability of the implemented care pathway.

In CONTACT-2, we will expand the development and implementation of a care pathway to 10 additional oncology centres in Flanders. In contrast to CONTACT-1, the CONTACT-2 oncology centres will take the lead in the development, implementation and evaluation of the care pathway, supported by the research team en by the CONTACT-Toolkit. This toolkit was developed based on the experiences from CONTACT-1 and international guidelines on the implementation of care pathways/complex interventions.

Similar to CONTACT-1, we hypothesise that the implementation of a care pathway will improve the level of self-management and the quality of patient-centred care, and will increase adherence, patient satisfaction and health-related quality of life. Next, we hypothesise that the care pathway will improve counselling practice, interdisciplinary collaboration, self-efficacy and self-confidence of healthcare professionals (HCP). The impact of a care pathway on the above outcomes in patients as well as in HCPs will be investigated by means of various assessments, that have been selected by the research team based on their experiences from CONTACT-1. Moreover, we hypothesize that the development and implementation process will be more efficient in the CONTACT-2 oncology centres, who will need less intensive support of the research team, due to the CONTACT-Toolkit. A process evaluation will be conducted to test this last hypothesis.

Further in-depth analysis of the impact of the care pathway, combined with a thorough process evaluation, should eventually lead to insight in the crucial factors for sustainable implementation of a care pathway, as well as to definite conclusions on its impact for patients and HCPs.

Throughout CONTACT-2, the CONTACT-toolkit will be further elaborated, optimised and digitised based on the experiences of the research team and feedback from the CONTACT-2 oncology centres. The toolkit will enable a nation-wide and sustainable implementation of similar care pathways for patients treated with OACD.

Clinical Trial Description

The study will be a prospective interventional multicentre before-after study with a total duration of 36 months and will be coordinated by a consortium of researchers from UGent and KU Leuven supported by Kom op Tegen Kanker. The intervention is the self-directed development and implementation of a care pathway in ten hospitals in Flanders.

The general lead throughout the study will be the 7-phase model for the development of a care pathway, which is translated to the specific context of OACD in the CONTACT-Toolkit. This methodology aims to offer a systematic approach for the support of an interdisciplinary team in the development of new care pathways or in the improvement of existing ones.

The CONTACT-Toolkit will serve as a roadmap that will guide the participating hospitals through the various phases and will therefore enable the self-directed development and implementation of the care pathway. Besides an overall guidance through the different phases of the 7-phase model, the toolkit contains additional tools including: presentations to structure internal meetings, tools and methods to map current practice, tools to measure key performance indicators, tools to support the development of a care pathway and tools to support counselling of patients treated with OACD (e.g. guide for telephone follow-up, guide for counselling at the start of the treatment).

In phase 1 and 2, a project structure is set up in each participating hospital by appointing a local coordinator and project team for the development of the care pathway. In phase 3, a detailed mapping of the current care process, which serves as before-study, will take place. Current practice will be evaluated from four different perspectives: own organisation and team, patients, external partners and independent observer. Assessments are performed by means of validated questionnaires and observations of daily practice by the research team. In phase 4, the care pathway will be developed by the project team, with respect to the results obtained from the mapping of current practice. During this phase, the research team will also provide training (i.e. e-learning, live training sessions) to all participating HCPs, to expand their medical knowledge on OACD and to improve counselling skills. The actual implementation of the care pathway is foreseen in phase 5. In phase 6, an evaluation of the care will be performed from the same four perspectives as in phase 3. This evaluation will include validated questionnaires, an interview with the coordinator, a focus group with the project team and participating HCPs and a second round of observations using a checklist and time task matrix of the care pathway document. In phase 7, the research team will take the necessary steps to guarantee the continuous follow-up of the care pathway without their further support.

To assess the impact of the care pathway on the level of the patient and the HCP, data obtained from the assessments in phase 3 (i.e. before-group) and 6 (i.e. after-group) will be compared. Furthermore, a process evaluation will be performed. ;

Related Conditions & MeSH terms

• Oncologic Disorders

• NCT number: NCT04142463
• Study type: Interventional
• Source: KU Leuven
• Contact: Ilyse Kenis, PharmD
• Phone: +32 16 19 31 82
• Email: ilyse.kenis@kuleuven.be
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Completion date: May 2022