Does being accompanied make a difference in communication during breast cancer consultations? Results from a multi-centered randomized controlled trial.

OBJECTIVES: This study is based on a multi-centered RCT conducted on breast cancer patients during their first consultation with an oncologist. The main aim was to evaluate whether the introduction of a communication tool (i.e., the Question Prompt Sheet or Question Listing), with or without a companion, impacted the number of questions asked by patients during the consultation, and subsequent psychological and relational outcomes. METHODS: The sample consisted of 324 breast cancer patients who were randomly placed into one of the two intervention groups: Question Prompt Sheet or Question Listing. Before and after the consultation, patients completed a set of standardized instruments: Satisfaction with decisions made during the consultation (SWD), Shared Decision Making Questionnaire (SDMQ-9), Patient Enablement Instrument (PEI), Patient Health Questionnaire Depression scale (PHQ-9), General Health Questionnaire (GHQ-12). RESULTS: The results indicate that the number of questions asked during the consultation was higher when a Question Listing was provided and when the patient was unaccompanied. Unaccompanied patients asked more questions in both groups and had significantly lower scores than accompanied on the GHQ-12 and on the PHQ-9, indicating lower clinical symptomatology. CONCLUSIONS: Results are in contrast with previous literature, indicating that being unaccompanied help patients to interact more with the oncologist. Further studies are needed to evaluate how the presence or not of a companion really impacts breast cancer patients during their first consultation with an oncologist. TRIAL REGISTRATION: ClinicalTrials.gov NCT01510964.

Employment status and information needs of patients with breast cancer: a multicentre cross-sectional study of first oncology consultations.

OBJECTIVES: To investigate the early information needs of women with a recent diagnosis of breast cancer (BC) according to their employment status. DESIGN: Cross-sectional. SETTING: Secondary-care patients attending three outpatient oncology clinics in northern Italy. PARTICIPANTS: 377 women with a recent diagnosis of early-stage, non-metastatic BC aged 18-75 were recruited. Of them, 164 were employed, 103 non-employed and 110 retired. OUTCOME MEASURES: The first consultation visit with an oncologist was audio-recorded and analysed for the number and type of questions asked. Linear regression models considering consultations' and patients' characteristics as confounding variables were applied. RESULTS: Employed patients asked significantly more questions than non-employed and retired patients (17 vs 13 and 14; F=6.04; p<0.01). When age and education were included in the statistical model, the significance of employment status was rearranged among all the variables and was no more significant (b=1.2, p=0.44). Employed women asked more questions concerning disease prognosis (0.7 vs 0.4 and 0.6; F=3.5; p=0.03), prevention (1.4 vs 0.6 and 0.7; F=10.7; p<0.01), illness management (7.2 vs 6 and 5.4; F=3.8; p=0.02) and social functioning (37% vs 18% and 20%; χ2=14.3; p<0.01) compared with the other two groups. Finally, they attended more frequently the consultation alone (37% vs 18% and 25%; χ2=10.90, p<0.01), were younger (50 vs 58 and 67 years; F=63.8; p<0.01) and with a higher level of education (77% vs 27% and 45%; χ2=68.2; p<0.01). CONCLUSIONS: Employment status is related to the type of questions asked during the first consultation. Also, it interrelates with other patients' characteristics like age and education in determining the number of questions asked. Patients' characteristics including employment status could be considered in tailoring work and social-related information provided during the first oncological consultation. Future studies could explore potential differences in information needs according to the different kinds of work.

Effects of a Question Prompt Sheet on the Oncologist-Patient Relationship: a Multi-centred Randomised Controlled Trial in Breast Cancer.

This study assessed the effect of a question prompt sheet (QPS) on the oncologist-patient relationship as compared with a question listing (QL). In particular, the differences in difficulties perceived by the oncologist during the consultation and in the patient's experience of the therapeutic aspects of the relationship were assessed. A total of 324 patients with a recent diagnosis of early stage breast cancer were involved in the study. The results showed that 15.7% of patients were perceived as 'difficult' by the oncologists. The proportion of 'difficult' patients varied in the two groups: 20.6% in the QPS group versus 11.8% in the QL group. The results also showed that the higher the difficulty perceived by oncologists, the lower the satisfaction of patients for their relationship with the oncologists during the consultation (r = - .135, p = .033). It is likely that the higher level of difficulty perceived by the oncologist in the QPS group may be connected with the pre-prepared list of evidence-based questions. Further research is needed to understand which components of the interventions, relating to the patient, the oncologist or their interaction, really promote patient participation in cancer setting. Trial registration: ClinicalTrials.gov NCT01510964. https://clinicaltrials.gov/ct2/show/NCT01510964.

Factors related to the expression of emotions by early-stage breast cancer patients.

OBJECTIVE: (1) To report the number and type of emotional expressions (cues/concerns) raised by breast cancer patients; (2) to identify the influence of setting, patient characteristics, and doctor-patient interaction on emotional expression. METHODS: 308 Italian-speaking female patients were recruited at their first breast cancer consultation. The visits were audio-recorded and analysed for number and type of emotional expressions (VR-CoDES). Oncologists' interaction skills were rated by the VR-COPE. Socio-demographic, clinical and personality variables were gathered before the consultation. Clinical variables and oncologists' evaluations of the patient were collected after. RESULTS: Breast cancer patients raised emotional issues mainly as cues. The setting (centre where the consultations took place), the oncologist's attribution of anxiety, regardless of anxiety test screening (STAI-X1) score before the consultation, and the oncologist's ability to pick up on patient's worries, handle emotional needs or understand psychosocial condition were all positively related with the number of emotional expressions. More tightly structured consultations had fewer emotional expressions. CONCLUSION: Both contextual and interactional aspects have an impact on patient emotional expressions. PRACTICE IMPLICATIONS: Oncologists need to be trained to manage both the content and the process of medical consultation. Work organization of the consultation setting needs to be taken into account.

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.

OBJECTIVES: To investigate, prior to an oncology consultation, the use of a pre-prepared list of evidence based questions, Question Prompt Sheet (QPS), compared with a Question List (QL), a patient self-generated list of questions. DESIGN: Multi-centred, randomised controlled trial. SETTING: Secondary-care patients attending three outpatient oncology clinics in Northern Italy. PARTICIPANTS: 308 women completed the study. Inclusion criteria were an age between 18 and 75 years, a recent diagnosis of early stage, non-metastatic breast cancer, adequate Italian language skills, no previous oncology visits and no evidence of cognitive impairment. INTERVENTION: Patients received the QPS or the QL prior to the consultation, completed it without suggestion or coaching session and delivered back before the visit.The consultations were audio-recorded and analysed for the number and content of questions. Multilevel linear models were used to compare the two groups. OUTCOME MEASURES: The primary outcome was the comparison of questions asked between QPS and QL group. Secondary outcomes included satisfaction about questions asked, satisfaction with decision, and level of anxiety. RESULTS: Patients in the QPS and QL group asked 13 and 16 questions respectively. The difference was not significant (b=1.7, CI -0.3 to 3.6, p=0.10). A mean of 22 questions was selected in the QPS, while a mean of 2 questions was written in the QL. Patients in the QPS group were significantly less satisfied (t=3.60, p<0.01) with questions asked but wanted less additional information (t=2.20, p<0.05). Levels of patient decisional satisfaction were equivalent between groups. Similarly, anxiety levels were equal between groups prior to the consultation and decreased in similar way after the consultation. CONCLUSIONS: Both interventions have similar impact on patients' participation in terms of question asking during the consultation. Future research is needed in order to explore which components of the interventions are really useful and efficacious. TRIAL REGISTRATION: ClinicalTrials.gov NCT01510964.

Shared decision making in Italy: An updated revision of the current situation.

The aim of this paper is to update the previous review on the state of patient and public participation in healthcare in Italy. Policymakers consider patient involvement an important aspect in health care decisions and encourage patients to actively participate in the clinical interaction. Nevertheless, the term shared decision making (SDM) is still not clearly defined. Patient associations promote patient participation in health care decisions. Several experts attended the latest consensus conference about patient engagement to reach a consensus on the definition of SDM. Research regarding SDM in Italy continues to increase with 17 articles published between 2012 and 2017. Researchers have assessed the variables associated with patient involvement and explored the use of the SDM approach in different medical settings. Despite the dedicated SDM initiative, researchers in Italy recognize room for improvement. Work is needed to reach a common language regarding SDM and its mechanisms to implement this approach at the clinical level.

Information needs of female Italian breast cancer patients during their first oncological consultation.

PURPOSE: Questions asked by patients during consultations reflect their most immediate information needs. The aim of this study is to observe the frequency and type of questions asked by Italian breast cancer patients and to explore associated factors. METHODS: Breast cancer patients at their first meeting with the oncologist were asked to complete five questionnaires (STAI-X1, PHQ-9, GHQ-12, CPS and DSES) before the consultation and three other questionnaires (PEI, SDM-Q, SWD) after. Consultations were audio taped and subsequently analyzed for the content and number of questions to identify patients' information requests. RESULTS: Patients asked an average of 18 questions, mainly about illness management: patients who were prescribed chemo-therapy asked more questions (t = -3.17, dof = 23.45, p < 0.01). Other factors related to a greater number of questions were younger age (r = -0.24, p = 0.05), being employed (t-test = 0.32; p = 0.04), and longer consultation length (r = 0.47, p < 0.01). CONCLUSION: Italian breast cancer patients asked on average more questions than in other countries. Knowledge of the factors associated with information needs can contribute to achieve a major involvement and consequently a better quality of patient-centered care.

Neurological soft signs and prepulse inhibition of the startle reflex in psychosis: A pilot study.

OBJECTIVE: Prepulse inhibition (PPI) of the startle reflex deficit and neurological soft signs (NSS) are two markers of vulnerability to psychosis. This study investigated the possibility of a PPI-NSS relation due to a putative common biological substrate, hypothesizing that patients with higher NSS scores also show higher PPI deficits. Moreover, we examined the possibility of an association of PPI deficits and NSS with negative symptoms. METHODS: Fifteen subjects with psychosis and fifteen healthy controls underwent PPI and NSS evaluations. RESULTS: Patients did not exhibit higher PPI deficits but only higher NSS rates (p < 0.01), as compared with healthy controls. Higher NSS rates were not associated with PPI deficits, and NSS sensory integration signs correlated positively with negative symptoms (p < 0.01). CONCLUSION: Our study supported the hypothesis that NSS are trait markers whereas PPI deficits state markers and that their putative common biological substrate is not sufficient to determinate an association between them. The study hypothesis, however, needs further investigation.

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

INTRODUCTION: Studies 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 ANALYSIS: All 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 DISSEMINATION: The 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 REGISTRATION: ClinicalTrials.gov identifier: NCT01510964.