Collaborative Network to Take Responsibility for Oral Anticancer Therapy

NCT ID: NCT02861209

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2022-11-30

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").

Conditions

Breast Cancer; ALL; Lung Cancer; Melanoma; Colorectal Cancer; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Non-care pathway

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Care Pathway

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.

Group Type: EXPERIMENTAL

Implementation of a care pathway

Intervention Type: OTHER

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.

Interventions

Implementation of a care pathway

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Lise-Marie Kinnaer

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AZ Turnhout

Turnhout, Antwerpen, Belgium

Site Status: RECRUITING

Maria Middelares Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

Imelda Bonheiden

Bonheiden, Vlaams-Brabant, Belgium

Site Status: RECRUITING

AZ Groeninge Kortrijk

Kortrijk, West-Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Lise-Marie Kinnaer, PharmD

Role: CONTACT

lisemarie.kinnaer@kuleuven.be

3216328265

Veerle Foulon, Prof. Dr.

Role: CONTACT

veerle.foulon@kuleuven.be

Facility Contacts

Lise-Marie Kinnaer, PharmD

Role: primary

lisemarie.kinnaer@kuleuven.be

16328265 ext. 32

Lise-Marie Kinnaer, PharmD

Role: primary

lisemarie.kinnaer@kuleuven.be

16328265 ext. 32

Lise-Marie Kinnaer, PharmD

Role: primary

lisemarie.kinnaer@kuleuven.be

16328265 ext. 32

Lise-Marie Kinnaer, PharmD

Role: primary

lisemarie.kinnaer@kuleuven.be

016328265 ext. 32

Veerle Foulon, Prof. Dr.

Role: backup

veerle.foulon@kuleuven.be

References

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.

Reference Type: DERIVED

PMID: 31310353 (View on PubMed)

Other Identifiers

LMK15022016

Identifier Type: -

Identifier Source: org_study_id