Collaborative Network to Take Responsibility for Oral Anticancer Therapy 2

NCT04142463 | Unknown

• 1 other identifier: IK20082019
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Oncologic Disorders

Keywords

Oral anticancer drugs; Self-management; Care pathway; Before-after study; Self-management support

Outcome Measures

Primary Outcomes (1)

• Change in self-management

  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. Questionnaire/method: Patient Activation Measure (PAM)

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

Secondary Outcomes (4)

• Change in adherence

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

• Change in patients' experience with information on OACD

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

• Change in Health Related Quality of Life

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

• Change in quality of patient-centred care

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

Other Outcomes (3)

• Change in clinician's beliefs on self-management

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

• Change in self-efficacy in HCPs

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

• Change in interdisciplinary collaboration

  At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)

Study Arms (2)

Before-group

NO INTERVENTION

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.

After-group

EXPERIMENTAL

This arm comprises patients who are recruited in phase 6 of the study, i.e. after the implementation of the care pathway.

Other: Care pathway

Interventions

Care pathway OTHER

A care pathway is a complex intervention for the mutual decision-making and organisation of care processes for a well-defined group of patients during a well-defined period. Care pathways can be used to optimise care processes when problems arise on communication, coordination, standardisation and monitoring of care for a specific group of patients. A care pathway for patients treated with OACD, should therefore consist of all relevant sustainable interventions that cover the continuum of the medicines' pathway with the aim to support self-management (e.g. consultations with doctors, contact moments with nurses, telephone follow-up, ...). The role of each stakeholder in the different interventions should be well-described including communication strategies between HCPs from primary and secondary care.

After-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilyse Kenis: lead
• Kom Op Tegen Kanker: collaborator
• KU Leuven: collaborator
• University Ghent: collaborator

Study Sites (10)

AZ Klina Brasschaat

Brasschaat, Antwerpen, 2930, Belgium

Location

UZA

Edegem, Antwerpen, 2650, Belgium

Location

ZNA Jan Palfijn

Merksem, Antwerpen, 2170, Belgium

Location

H. Hartziekenhuis Mol

Mol, Antwerpen, 2400, Belgium

Location

Sint-Trudo ziekenhuis Sint-Truiden

Sint-Truiden, Limburg, 3800, Belgium

Location

AZ Vesalius Tongeren

Tongeren, Limburg, 3700, Belgium

Location

AZ Glorieux Ronse

Ronse, Oost-Vlaanderen, 9600, Belgium

Location

AZ Jan Portaels Vilvoorde

Vilvoorde, Vlaams-Brabant, 1800, Belgium

Location

AZ Sint-Lucas Brugge

Bruges, West-Vlaanderen, 8310, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Related Publications (1)

• Kinnaer 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 BACKGROUND

MeSH Terms

Interventions

Critical Pathways

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Veerle Foulon, Prof. Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilyse Kenis, PharmD

CONTACT

+32 16 19 31 82; ilyse.kenis@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Researcher

Model Details: Patients will be recruited in phase 3 of the study, i.e. before the implementation of the care pathway (before-group) and in phase 6, i.e. after the implementation of the care pathway (after-group)

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: October 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (10)