INvolvement of breast CAncer patients during oncological consultations: a multicentre randomised controlled trial—the INCA study protocol

Abstract

IntroductionStudies on patient involvement show that physicians make few attempts to involve their patients who ask few questions if not facilitated. On the other hand, the patients who participate in the decision-making process show greater treatment adherence and have better health outcomes. Different methods to encourage the active participation during oncological consultation have been described; however, similar studies in Italy are lacking. The aims of the present study are to (1) assess the effects of a preconsultation intervention to increase the involvement of breast cancer patients during the consultation, and (2) explore the role of the attending companions in the information exchange during consultation.Methods and analysisAll female patients with breast cancer who attend the Oncology Out-patient Services for the first time will provide an informed consent to participate in the study. They are randomly assigned to the intervention or to the control group. The intervention consists of the presentation of a list of relevant illness-related questions, called a question prompt sheet. The primary outcome measure of the efficacy of the intervention is the number of questions asked by patients during the consultation. Secondary outcomes are the involvement of the patient by the oncologist; the patient's perceived achievement of her information needs; the patient's satisfaction and ability to cope; the quality of the doctor–patient relationship in terms of patient-centeredness; and the number of questions asked by the patient's companions and their involvement during the consultation. All outcome measures are supposed to significantly increase in the intervention group.Ethics and disseminationThe study was approved by the local Ethics Committee of the Hospital Trust of Verona. Study findings will be disseminated through peer-reviewed publications and conference presentations.Trial registrationClinicalTrials.gov identifier: NCT01510964

Use of the 9-item Shared Decision Making Questionnaire (SDM-Q-9 and SDM-Q-Doc) in intervention studies—A systematic review

“…Two of six studies will use both SDM-Q-9 and SDM-Q-Doc [ 49 , 53 ]. There will be one adaptation of the instrument for a patient’s companion [ 54 ] and one for an observer’s perspective [ 49 ]. One study protocol reported an assessment of SDM-Q-9 directly after the clinician-patient-consultation [ 54 ].…”

The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing

“…Physician participants were the oncologists treating these patients in one of three outpatient clinics in Northern Italy run by the Hospital Trusts of Verona and Brescia. 24 …”

“…The unpaired t-test had a power of 80%, a significance level of 5% while taking into account a withdrawal rate of 15% (more details in the protocol). 24 …”

A review of question prompt lists used in the oncology setting with comparison to the Patient Concerns Inventory

“…; Goss et al . ). Physicians must be able to successfully communicate information to patients, in order that they are able to make relevant treatment decisions based on the requisite information given.…”

“…Thus, it is imperative that physicians are able to discern which areas are most important to the patient and deliver the information that is most relevant to their needs (Goss et al . ; Domain Team/Person Centred Care Team/Coalition for Collaborative Care ). One way in which physicians can derive patient preferences more easily is by encouraging patients to actively participate in consultations (Jefford & Tattersall ).…”