Clinical trial · Interventional
Collaborative Network to Take Responsibility for Oral Anticancer Therapy 2
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncologic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Care pathway | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Before-group
- description
- This arm comprises patients who are recruited in phase 3 of the study, i.e. before the implementation of the care pathway. It is intended that patients included in phase 3 serve as a control-group for patients included in phase 6.
- type
- EXPERIMENTAL
- label
- After-group
- description
- This arm comprises patients who are recruited in phase 6 of the study, i.e. after the implementation of the care pathway.
- interventionNames
- Other: Care pathway
Primary outcomes (1)
- measure
- Change in self-management
- timeFrame
- At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A solid tumor and/or a haematological cancer * Treated with one or more OACD (registered, "medical need" of "compassionate use") * Able to swallow or retain oral medication Exclusion Criteria: * Following an adjuvant hormonal therapy with OACD (e.g. tamoxifen for 5 or 10 years) * Following a therapy with a study drug in a phase I, II or III clinical trial * Not able to understand Dutch
References
Publications (1)
- BACKGROUNDKinnaer LM, Decoene E, Van Hecke A, Foulon V. Collaborative network to take responsibility for oral anticancer therapy (CONTACT): Study-protocol investigating the impact of a care pathway. J Adv Nurs. 2019 Dec;75(12):3726-3739. doi: 10.1111/jan.14157. Epub 2019 Aug 27. PMID 31310353