Breast CancerCONTACTNCT02861209
Collaborative Network to Take Responsibility for Oral Anticancer Therapy
A study testing Implementation of a care pathway in people with Breast Cancer and ALL, run by KU Leuven at 4 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, ALL, Lung Cancer
- What is being tested?
- Implementation of a care pathway
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 4 sitesBelgium
- Study dates
- Nov 2015to Nov 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 hematological cancer of solid tumor
- starting an oral anticancer drug for the first time
- able to understand and speak Dutch
Who cannot join
- patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
- patients following a therapy with a study drug
Trial locations and contacts
4 sites in 1 country.
Veerle Foulon, Prof. Dr. contact
Belgium4 sites, 4 recruiting
- Recruiting
Imelda Bonheiden
Bonheiden, Vlaams-Brabant, 2820
Lise-Marie Kinnaer, PharmD, 16328265 ext. 32, lisemarie.kinnaer@kuleuven.be
- Recruiting
Maria Middelares Gent
Ghent, Oost-Vlaanderen, 9000
Lise-Marie Kinnaer, PharmD, 16328265 ext. 32, lisemarie.kinnaer@kuleuven.be
- Recruiting
AZ Groeninge Kortrijk
Kortrijk, West-Vlaanderen, 8000
Lise-Marie Kinnaer, PharmD, 016328265 ext. 32, lisemarie.kinnaer@kuleuven.be
Veerle Foulon, Prof. Dr., veerle.foulon@kuleuven.be
- Recruiting
AZ Turnhout
Turnhout, Antwerpen, 2300
Lise-Marie Kinnaer, PharmD, 16328265 ext. 32, lisemarie.kinnaer@kuleuven.be
About this study
Official title: 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.
Read more
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.
Read the detailed description
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").
- Conditions
- Breast Cancer, ALL, Lung Cancer, Melanoma, Colorectal Cancer, Prostate Cancer
- Being tested
- Implementation of a care pathway
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Melanoma, Colorectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-care pathway | No intervention | 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. |
| Care Pathway | Experimental | 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. Receives: Other: Implementation of a care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-management skills
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".
Measured: at the start of the therapy, after one and three months
Secondary outcomes (8)
Change in medication Adherence
Measured: after one and three months of therapy
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Measured: after one and three months
Change in patient satisfaction with care using Out-patsat 35
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
Measured: at the start of the therapy, after one and three months
Health Related Quality of Life
Measured: at the start of the therapy, after one and three months
Change in Distress using the Distress Barometer
Measured: at the start of the therapy, after one and three months
Efficacy of treatment Using ECOG performance scale and RECIST criteria
Measured: at the start of the therapy, after one and three months
Toxicity of treatment
Summarizing adverse drug events
Measured: at the start of the therapy, after one and three months
Cost of care
Prospective report on health care expenditures (use of healthcare and other services, use of medicines, …)
Measured: at the start of the therapy, after one and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2022 (estimated)
- Study completionNov 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 Breast CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise-Marie Kinnaer, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861209
- Sponsor's protocol ID
- LMK15022016
- Acronym
- CONTACT
- Status last verified
- Apr 2019
- First submitted
- 2 Aug 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02861209
- Acronym / sponsor ID
- CONTACT / LMK15022016
- Conditions
- Breast Cancer, ALL, Lung Cancer, Melanoma, Colorectal Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- 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.
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.
Detailed description
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").
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-care pathway | No intervention | –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. |
| Care Pathway | Experimental | Other: Implementation of a care pathwayThis 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. |
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 hematological cancer of solid tumor
- starting an oral anticancer drug for the first time
- able to understand and speak Dutch
Key exclusion criteria (2 listed)
- patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
- patients following a therapy with a study drug
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 |
|---|---|---|
| Implementation of a care pathwayThe 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. | Other | Care Pathway |
Primary outcome
Change in self-management skills
Time frame: 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".
8 secondary outcomes
Change in medication Adherence
Time frame: after one and three months of therapy
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time frame: after one and three months
Change in patient satisfaction with care using Out-patsat 35
Time frame: at the start of the therapy, after one and three months
Health Related Quality of Life
Time frame: at the start of the therapy, after one and three months
Change in Distress using the Distress Barometer
Time frame: at the start of the therapy, after one and three months
Efficacy of treatment Using ECOG performance scale and RECIST criteria
Time frame: at the start of the therapy, after one and three months
Toxicity of treatment
Time frame: at the start of the therapy, after one and three months
Cost of care
Time frame: at the start of the therapy, after one and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: 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. contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a care pathway in people with Breast Cancer and ALL, run by KU Leuven at 4 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 2 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Lise-Marie Kinnaer, PharmD (3216328265, lisemarie.kinnaer@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 skills (time frame: at the start of the therapy, after one and three months). 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 NCT02861209, 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 16 Apr 2019.