Oncologic DisordersCONTACT-2NCT04142463
Collaborative Network to Take Responsibility for Oral Anticancer Therapy 2
A study testing Care pathway in people with Oncologic Disorders, run by Ilyse Kenis at 10 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Disorders
- What is being tested?
- Care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 10 sitesBelgium
- Study dates
- Oct 2019to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites
ZNA Middelheim
Antwerp, 2020
M. El Marchouhi
A. Vandebroek, MD
AZ Klina Brasschaat
Brasschaat, Antwerpen, 2930
M. Deburchgrave
D. Verhoeven, MD
AZ Sint-Lucas Brugge
Bruges, West-Vlaanderen, 8310
T. Maerten
D. De Maeseneer, MD
UZA
Edegem, Antwerpen, 2650
S. Kohl
C. De Bondt, MD
ZNA Jan Palfijn
Merksem, Antwerpen, 2170
V. Jacobs
S. Van Wambeke, MD
H. Hartziekenhuis Mol
Mol, Antwerpen, 2400
S. Van Campfort
M. Martens, MD
AZ Glorieux Ronse
Ronse, Oost-Vlaanderen, 9600
L. Boutens
B. Ghillemijn, MD
Sint-Trudo ziekenhuis Sint-Truiden
Sint-Truiden, Limburg, 3800
AZ Vesalius Tongeren
Tongeren, Limburg, 3700
AZ Jan Portaels Vilvoorde
Vilvoorde, Vlaams-Brabant, 1800
K. Lanin
S. Ahlal, MD
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Oncologic Disorders
- Being tested
- Care pathway
- Keywords
- Oral anticancer drugs, Self-management, Care pathway, Before-after study, Self-management support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Secondary outcomes (4)
Change in adherence
Questionnaire/method: Probabilistic Medication Adherence Scale (ProMAS)
Measured: 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
Questionnaire/method: Satisfaction with Information about Medicines Scale (SIMS)
Measured: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Change in Health Related Quality of Life
Questionnaire/method: Functional Assessment of Cancer Therapy - General
Measured: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Change in quality of patient-centred care
Questionnaire/method: CONTACT Patient-Centred Care Evaluation Questionnaire (PCCEQ)
Measured: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oncologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilyse Kenis
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker, KU Leuven, University Ghent
- Responsible party
- Sponsor-investigator, Ilyse Kenis, KU Leuven
- Investigators
- Veerle Foulon, Prof. Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142463
- Sponsor's protocol ID
- IK20082019
- Acronym
- CONTACT-2
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31310353
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04142463
- Acronym / sponsor ID
- CONTACT-2 / IK20082019
- Conditions
- Oncologic Disorders
- Keywords
- Oral anticancer drugs, Self-management, Care pathway, Before-after study, Self-management support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ilyse KenisUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker, KU Leuven, University Ghent
- Study start
- Oct 2019 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Care pathwayThis arm comprises patients who are recruited in phase 6 of the study, i.e. after the implementation of the care pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care pathwayA 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. | Other | After-group |
Primary outcome
Change in self-management
Time frame: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
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)
4 secondary outcomes
Change in adherence
Time frame: 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
Time frame: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Change in Health Related Quality of Life
Time frame: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Change in quality of patient-centred care
Time frame: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Background: PubMed 31310353Kinnaer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veerle Foulon, Prof. Dr. principal investigator
KU Leuven
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care pathway in people with Oncologic Disorders, run by Ilyse Kenis at 10 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilyse Kenis, PharmD (+32 16 19 31 82, ilyse.kenis@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-management (time frame: At baseline (before implementation of the care pathway); After 24 months (after implementation of the care pathway)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.