Clinical trial NCT02861209: Collaborative Network to Take Responsibility for Oral Anticancer Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
ALL
Lung Cancer
Melanoma
Colorectal Cancer
Prostate Cancer
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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").

Eligibility criteria: Inclusion Criteria:

* a hematological cancer of solid tumor
* starting an oral anticancer drug for the first time
* able to understand and speak Dutch

Exclusion Criteria:

* patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
* patients following a therapy with a study drug

Primary outcomes:
measure: Change in self-management skills
timeFrame: at the start of the therapy, after one and three months
Secondary outcomes:
measure: Change in medication Adherence
timeFrame: after one and three months of therapy
measure: Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
timeFrame: after one and three months
measure: Change in patient satisfaction with care using Out-patsat 35
timeFrame: at the start of the therapy, after one and three months
measure: Health Related Quality of Life
timeFrame: at the start of the therapy, after one and three months
measure: Change in Distress using the Distress Barometer
timeFrame: at the start of the therapy, after one and three months
measure: Efficacy of treatment Using ECOG performance scale and RECIST criteria
timeFrame: at the start of the therapy, after one and three months
measure: Toxicity of treatment
timeFrame: at the start of the therapy, after one and three months
measure: Cost of care
timeFrame: at the start of the therapy, after one and three months
Other outcomes:
measure: Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS)
timeFrame: at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
measure: Change in perceptions on self-management in HCPs using the Clinician Support for Patient activation measure
timeFrame: at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
Locations:
city: Turnhout
country: Belgium
facility: AZ Turnhout
state: Antwerpen
city: Ghent
country: Belgium
facility: Maria Middelares Gent
state: Oost-Vlaanderen
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
state: West-Vlaanderen
Study officials:
References:
citation: 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.