Collaborative Network to Take Responsibility for Oral Anticancer Therapy — CONTACT  

Breast Cancer Clinical Trial

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

Status Recruiting

Clinical 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.

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.

Clinical Trial 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"). ;

Related Conditions & MeSH terms

• ALL
• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Melanoma
• Prostate Cancer

• NCT number: NCT02861209
• Study type: Interventional
• Source: KU Leuven
• Contact: Lise-Marie Kinnaer, PharmD
• Phone: 3216328265
• Email: lisemarie.kinnaer@kuleuven.be
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Completion date: November 2022