The Causal Relationship Between Portal Usage and Self-Efficacious Health Information-Seeking Behaviors: Secondary Analysis of the Health Information National Trends Survey Data.

BACKGROUND: Patient portals have drawn much attention, as they are considered an important tool for health providers in facilitating patient engagement. However, little is known about whether the intensive use of patient portals contributes to improved management of patients' health in terms of their confidence in acquiring health information and exercising self-care. There is a lack of randomized trials with these outcomes measured both pre- and postadoption of patient portals. OBJECTIVE: The aim of this study was to examine the causal relationship between the usage of patient portals and patients' self-efficacy toward obtaining health information and performing self-care. METHODS: This study was a secondary data analysis that used data from a US national survey, the National Cancer Institute's Health Information National Trends Survey 5 Cycle 1. Patient portal usage frequency was used to define the treatment. Survey items measuring self-efficacy on a Likert-type scale were selected as the main outcomes, including patients' confidence in obtaining health information and performing self-care. To establish causality using survey data, we adopted the instrumental variables method. To determine the direction of the causal relationship in the presence of high-dimensional confounders, we further proposed a novel testing framework that employs conditional independence tests in a directed acyclic graph. The average causal effect was measured using the two-stage least squares regression method. RESULTS: We showed that frequently using patient portals improves patients' confidence in obtaining health information. The estimand of the weighted average causal effect was 0.14 (95% CI 0.06-0.23; P<.001). This means that when increasing the portal usage intensity, for instance, from 1-2 times to 3-5 times per year, the expected average increase in confidence level measured on a Likert-type scale would be 0.14. However, we could not conclusively determine the causal effect between patient portal usage and patients' confidence in exercising self-care. CONCLUSIONS: The results support the use of patient portals and encourage better support and education to patients. The proposed statistical method can be used to exploit the potential of national survey data for causal inference studies.

Identifying How Patient Portals Impact Communication in Oncology.

Patient portals are becoming widespread throughout health-care systems. Initial research has demonstrated that they positively impact patient-provider communication and patients' health knowledge, but little is known about the impact of patient portals in the cancer setting, where highly complex and uncertain medical data are available for patients to view. To better understand communicative behaviors and perceptions of the patient portal and how it is utilized in oncology, in-depth, semi-structured interviews were conducted with 48 participants: 35 patients and 13 oncologists. Thematic analysis identified that portals help to enhance participation during in-person consultations, increase patients' self-advocacy, and build rapport with providers. However, patients' comfort level with reviewing information via the portal depended upon the severity of the test. Oncologists worried about patient anxiety and widening health disparities, but acknowledged that the portal can motivate them to expedite communication about laboratory and scan results. As patient portals become more widely used in all medical settings, oncologists should become more engaged with how patients are viewing their medical information and consider the portal within the framework of patient-centered care by valuing patients' communication preferences.

Employee to employer communication skills: balancing cancer treatment and employment.

BACKGROUND: Cancer patients face difficulties in accessing legally mandated benefits and accommodations when they return to the workplace. Poor employer-employee communication inflates these difficulties. Although proven methods to facilitate physician-patient communication exist, these have not been applied to the workplace. Thus, we aimed to assess the feasibility and utility of applying these methods to educate patients about their workplace rights and provide them with communication skills training to aid their conversations with their employers. METHODS: A DVD was produced to educate patients and facilitate workplace communication. Participants consisted of 28 solid tumor cancer patients (14 women and 14 men) who completed primary cancer treatment in the past 12 months and were employed at the time of diagnosis. Participants watched a communication skills training DVD and completed a telephone interview. The interview elicited information about workplace experiences and evaluation of the DVD training program. RESULTS: The physician-patient communication skills training model utilized was successfully translated to the employer-employee setting. All but one participant found the DVD useful and easy to understand and indicated a high degree of confidence in using the communication skills to help them ask for workplace accommodations. All participants agreed that it would help newly diagnosed patients in discussions with their employers. CONCLUSION: Our data provides promising preliminary evidence that patient communication skills training can be applied to the workplace setting and is a welcomed aid to newly diagnosed cancer patients in their discussions with employers regarding the impact of treatment on their work performance and needs for accommodations.

Adjuvant chemotherapy non-adherence, patient-centered communication, and patient-level factors in elderly breast and colon cancer patients.

BACKGROUND: We examined patient-level factors (patient characteristics, disease and treatment factors, and patient experience), patient-centered communication (PCCM), and non-adherence to adjuvant chemotherapy (AC) guidelines among breast and colon cancer patients to inform AC adherence promotion and improve clinical outcomes. METHODS: Descriptive statistics for patient-level factors, PCCM, and AC non-adherence (primary non-adherence, non-persistence at 3 and 6 months) were obtained. Multiple logistic regression models were used to estimate AC non-adherence after accounting for the identified patient-level factors. RESULTS: The majority of the sample (n = 577) were White (87%), breast cancer patients (87%), and reported PCCM (provider communication score ≥ 90%, 73%, provider communication score = 100%, 58%). All three levels of AC nonadherence were significantly higher in breast cancer patients (69%, 81%, and 89% for primary non-adherence, and non-persistence at 3 and 6 months, respectively) than colon cancer patients (43%, 46%, and 62%, respectively). Male sex, survey assistance, and low/average ratings of a personal doctor, specialist, and healthcare were associated with lower PCCM. Older age, breast cancer diagnosis, and diagnosis group following 2007-2009 increased the likelihood of all three levels of AC non-adherence. Comorbidities and PCCM-90 were exclusively associated with non-persistence at 3 months. CONCLUSIONS: Adjuvant chemotherapy non-adherence varied by cancer diagnosis and treatment factors. The relationship between PCCM and AC non-adherence differed by level of PCCM, time period, and the presence of comorbidities. AC guideline adherence, communication, and value-concordant treatment should be assessed and compared simultaneously to improve our understanding of their interrelationships.

Perceived discrimination and physical activity mediate the associations between receiving a survivorship care plan and cancer pain.

BACKGROUND: Survivorship care plan helps improve the continuity of care and manage ongoing pain that affects up to 46% of cancer survivors by promoting health behaviors, including physical activity. However, perceived discrimination may decrease the likelihood of cancer survivors participating in physical activities and negatively influence their pain status. Thus, this study aimed to examine the mediating role of physical activity and perceived discrimination in the relationship between receiving a survivorship care plan and cancer pain. METHODS: This cross-sectional, correlational study utilized data from the 2012-2019 Behavioral Risk Factor Surveillance System. Analyses accounted for the complex survey design. Logistic regression was utilized to analyze the association among survivorship care plans, discrimination, physical activity, and pain. Generalized structural equation modeling was conducted to test a hypothesized model in which survivorship care plans and discrimination affect physical activity, and subsequently influence pain status. RESULTS: Forty-two and 81% of survivors reported receiving treatment summaries and follow-up care plans, respectively, and 8% experienced cancer pain. After controlling for covariates, the highest discrimination quintile was three times more likely to report cancer pain than the lowest quintile. While receiving follow-up care plans was positively related to cancer pain, respondents in the third- to fifth- quintiles were less likely to report cancer pain when receiving follow-up care plans than the first quintile respondents. Physical activity mediated the association between discrimination and cancer pain. CONCLUSIONS: Reverse relationships between receiving follow-up care plans and cancer pain existed; however, discrimination and physical activity mediated these relationships.

Understanding racial-ethnic differences in patient-centered care (PCC) in oncology through a critical race theory lens: A qualitative comparison of PCC among Black, Hispanic, and White cancer patients.

OBJECTIVES: Patient-centered care (PCC) experiences can vary by race and ethnicity and likely contribute to cancer care disparities. We compared PCC concepts between Non-Hispanic White (White), Hispanic, and Non-Hispanic Black (Black) cancer patients utilizing Critical Race Theory (CRT) to understand the relationships between racial-ethnic identity and PCC. METHODS: A thematic analysis and in-depth CRT-informed analysis of individual interviews exploring patient values, unmet needs, preferences, and priorities were performed. RESULTS: Participants were aged> 25 yrs old, 53% male, and included 5 Hispanic, 4 Black and 6 White cancer patients. Unmet needs for time to make decisions, and provider interaction between visits and the value for finding meaning in the illness emerged among Blacks and Whites. The unmet need for a long-term treatment plan emerged among Blacks, and the preference of research participation among Whites. A value for optimism was observed among Hispanics and Whites. Racial-ethnic variations in patient descriptions and experiences of their values, unmet needs, preferences, and priorities were identified. CONCLUSIONS: Underrepresented groups face subtle but significant challenges in feeling cared for and understood, voicing concerns, and obtaining quality care. PRACTICE IMPLICATIONS: Increased mutual understanding and provider knowledge of unique PCC experiences among underrepresented cancer patients are needed.

Enhancing decision making about participation in cancer clinical trials: development of a question prompt list.

PURPOSE: Slow accrual to cancer clinical trials impedes the progress of effective new cancer treatments. Poor physician-patient communication has been identified as a key contributor to low trial accrual. Question prompt lists (QPLs) have demonstrated a significant promise in facilitating communication in general, surgical, and palliative oncology settings. These simple patient interventions have not been tested in the oncology clinical trial setting. We aimed to develop a targeted QPL for clinical trials (QPL-CT). METHOD: Lung, breast, and prostate cancer patients who either had (trial experienced) or had not (trial naive) participated in a clinical trial were invited to join focus groups to help develop and explore the acceptability of a QPL-CT. Focus groups were audio-recorded and transcribed. A research team, including a qualitative data expert, analyzed these data to explore patients' decision-making processes and views about the utility of the QPL-CT prompt to aid in trial decision making. RESULTS: Decision making was influenced by the outcome of patients' comparative assessment of perceived risks versus benefits of a trial, and the level of trust patients had in their doctors' recommendation about the trial. Severity of a patient's disease influenced trial decision making only for trial-naive patients. CONCLUSION: Although patients were likely to prefer a paternalistic decision-making style, they expressed valuation of the QPL as an aid to decision making. QPL-CT utility extended beyond the actual consultation to include roles both before and after the clinical trial discussion.

Sharing decisions in breast cancer care: Development of the Decision Analysis System for Oncology (DAS-O) to identify shared decision making during treatment consultations.

BACKGROUND: Shared Decision Making (SDM) is widely accepted as the preferred method for reaching treatment decisions in the oncology setting including those about clinical trial participation: however, there is some disagreement between researchers over the components of SDM. Specific standardized coding systems are needed to help overcome this difficulty. OBJECTIVE: The first objective was to describe the development of an oncology specific SDM coding system, the DAS-O. The second objective was to provide reliability and validity data supporting the DAS-O. SETTING AND PARTICIPANTS: Consultation data were available from tertiary cancer center out patient oncology clinics in: Australia, New Zealand (ANZ), Switzerland, Germany and Austria (SGA). Patients were women with a confirmed diagnosis of early stage breast cancer. Reliability data were from 18 randomly selected coded transcripts drawn from ANZ and SGA. Concurrent validity data are from 55 (ANZ) consultations. MEASUREMENT: Inter and Intra rater reliability data was evaluated using Kappa correlation statistics and correlation coefficients. Correlation coefficients were used to assess concurrent validity between the DAS-O and two other SDM coding systems, OPTION and DSAT. RESULTS: Inter and Intra rater reliability for the system were high with average Kappas of 0.58 and 0.65 respectively. Correlation coefficients between DAS-O and OPTION was 0.73 and >0.5 for DSAT. CONCLUSIONS: We have developed a reliable and valid coding system for identifying and rating the quality of SDM in breast cancer consultations.

Developing and implementing an advanced communication training program in oncology at a comprehensive cancer center.

Cancer patients report significant levels of unmet needs in the realm of communication. Communication skills training programs have been shown to improve clinical communication. However, advanced communication skills training programs in oncology have lacked institutional integration, and thus have not attended to institutional norms and cultures that may counteract explicit communication skills training. We developed and implemented an advanced communication skills training program made up of nine teaching modules for faculty, fellows, and residents. Training included didactic and experiential small group work. Self-efficacy and behavior change were assessed for individual participants. Since 2006, 515 clinicians have participated in this training program. Participants have shown significant gains in self-efficacy regarding communicating with patients in various contexts. Our initial work in this area demonstrates the implementation of such a program at a major cancer center to be feasible, to be acceptable, and to have a significant impact on participants' self-efficacy.

A Call to Action: Ethics Committee Roundtable Recommendations for Addressing Burnout and Moral Distress in Oncology.

Oncologist well-being is critical to initiating and maintaining the physician-patient relationship, yet many oncologists suffer from symptoms of burnout. Burnout has been linked to poor physical and mental health, as well as increased medical errors, patient dissatisfaction, and workforce attrition. In this Call to Action article, we discuss causes of and interventions for burnout and moral distress in oncology, highlight existing interventions, and provide recommendations for addressing burnout and improving well-being at the individual and organizational levels to deliver ethical, quality cancer care.

Assessing facilitator competence in a comprehensive communication skills training programme.

OBJECTIVES: Evidence suggests that the most important component of communication skills training (CST) is experiential learning through role-play sessions that rely on facilitators to guide learners. However, there is little published evidence about processes of assessing facilitator competence in CST. This paper reports on the development and application of procedures to assess facilitator competence in a large-scale CST programme. METHODS: Thirty-two novice facilitators in a large CST programme were audio-recorded while facilitating small-group CST training sessions in order to explore whether the training they had received had prepared them to competently facilitate. Audio-recordings were assessed using the Comskil facilitator assessment coding system. Facilitators were rated as having achieved basic competence, advanced competence or expert competence. RESULTS: Facilitation tasks that were most frequently coded as being used always included inviting the learner to give feedback first and inviting all group members to give feedback. The facilitation task coded least frequently as being used always was involving group members in solving problems. Of the 32 facilitators, 18 reached at least a basic level of competence. Psychosocially trained facilitators and MD facilitators differed in their use of five facilitation tasks. CONCLUSIONS: Modest training and minimal practice does not result in complete facilitator competence. Some facilitation skills appear to be more easily acquired than others. These findings highlight which skills should be prioritised in the further training of novice facilitators. A long-term project currently underway will study whether facilitator competence improves with practice and regular feedback.

Conducting family meetings in palliative care: themes, techniques, and preliminary evaluation of a communication skills module.

OBJECTIVE: To develop a communication skills training module for health care professionals about how to conduct a family meeting in palliative care and to evaluate the module in terms of participant self-efficacy and satisfaction. METHODS: Forty multispecialty health care professionals from the New York metropolitan area attended a communication skills training module at a Comprehensive Cancer Center about how to conduct a family meeting in oncology. The modular content was based on the Comskil model and current literature in the field. RESULTS: Based on a retrospective pre-post measure, participants reported a significant increase in self-efficacy about their ability to conduct a family meeting. Furthermore, at least 93% of participants expressed their satisfaction with various aspects of the module by agreeing or strongly agreeing with statements on the course evaluation form. SIGNIFICANCE OF RESULTS: Family meetings play a significant role in the palliative care setting, where family support for planning and continuing care is vital to optimize patient care. Although these meetings can be challenging, this communication skills module is effective in increasing the confidence of participants in conducting a family meeting.

OpenNotes in oncology: oncologists' perceptions and a baseline of the content and style of their clinician notes.

Patients' ability to access their provider's clinical notes (OpenNotes) has been well received and has led to greater transparency in health systems. However, the majority of this research has occurred in primary care, and little is known about how patients' access to notes is used in oncology. This study aims to understand oncologists' perceptions of OpenNotes, while also establishing a baseline of the linguistic characteristics and patterns used in notes. Data from 13 in-depth, semistructured interviews with oncologists were thematically analyzed. In addition, the Linguistic Inquiry and Word Count (LIWC) program evaluated over 200 clinician notes, measuring variables encompassing emotions, thinking styles, social concerns, and parts of speech. Analysis from LIWC revealed that notes contained negative emotional tone, low authenticity, high clout, and high analytical writing. Oncologists' use of stigmatized and sensitive words, such as "obese" and "distress," was mainly absent. Themes from interviews revealed that oncologists were uncertain about patients' access to their notes and may edit their notes to avoid problematic terminology. Despite their reluctance to embrace OpenNotes, they envisioned opportunities for an improved patient-provider relationship due to patients initiating interactions from viewing notes. Oncologists believe notes are not intended for patients and altering their content may compromise the integrity of the note. This study established a baseline for further study to compare notes pre-implementation to post-implementation. Further analysis will clarify whether oncologists are altering the style and content of their notes and determine the presence of patient-centered language.

Patient access to clinical notes in oncology: A mixed method analysis of oncologists' attitudes and linguistic characteristics towards notes.

BACKGROUND: Providers have expressed concern about patient access to clinical notes. There is the possibility that providers may linguistically censor notes knowing that patients have access. PURPOSE: Qualitative interviews and a pre- and post- linguistic analysis of the implementation of OpenNotes was performed to determine whether oncologists changed the content and style of their notes. METHODS: Mixed methods were utilized, including 13 semi-structured interviews with oncologists and random effects modeling of over 500 clinical notes. The Linguistic Inquiry and Word Count program was used to evaluate notes for emotions, thinking styles, and social concerns. RESULTS: No significant differences from pre- and post-implementation of OpenNotes was found. Thematic analysis revealed that oncologists were concerned that changing their notes would negatively impact multidisciplinary communication. However, oncologists acknowledged that notes could be more patient-friendly and may stimulate patient-provider communication. CONCLUSIONS: Although oncologists were aware that patients could have access, they felt strongly about not changing the content of notes. A comparison between pre- and post-implementation confirmed this view and found that notes did not change. PRACTICE IMPLICATIONS: Patient access to oncologist's notes may serve as an opportunity to reinforce important aspects of the consultation.

Communication skills training for healthcare professionals in oncology over the past decade: a systematic review of reviews.

PURPOSE OF REVIEW: Effective communication in cancer care requires complex communication skills of healthcare professionals (HCPs), which can be advanced by communication skills training (CST). The number of empirical studies on CST has grown steadily over the last decade. However, controversies on CST abound. The aim of this review of reviews is to summarize evidence for the effectiveness of CST in oncology as well as for effective CST features (intensity, format and content) and to synthesize the current opinion on CST. RECENT FINDINGS: The evidence synthesized from multiple reviews supported the effect of CST on HCPs' communication skills. Yet, the certainty of evidence was limited as studies were diverse and effects heterogeneous. Furthermore, limited evidence was found for effective CST intensity, format and content. Authors of the reviews advocated further high-quality research with robust outcome measurement to establish the most essential features of CST and recommended implementation of CST in the standard training of HCPs with continuous supervision. SUMMARY: CST can probably improve some aspects of HCPs' communication skills. Despite the uncertain evidence, implementation of CST into clinical practice is widely advocated and specific recommendations regarding intensity and format are provided. Evidence to justify and substantiate implementation efforts is needed.

Communication skills training: describing a new conceptual model.

Current research in communication in physician-patient consultations is multidisciplinary and multimethodological. As this research has progressed, a considerable body of evidence on the best practices in physician-patient communication has been amassed. This evidence provides a foundation for communication skills training (CST) at all levels of medical education. Although the CST literature has demonstrated that communication skills can be taught, one critique of this literature is that it is not always clear which skills are being taught and whether those skills are matched with those being assessed. The Memorial Sloan-Kettering Cancer Center Comskil Model for CST seeks to answer those critiques by explicitly defining the important components of a consultation, based on Goals, Plans, and Actions theories and sociolinguistic theory. Sequenced guidelines as a mechanism for teaching about particular communication challenges are adapted from these other methods. The authors propose that consultation communication can be guided by an overarching goal, which is achieved through the use of a set of predetermined strategies. Strategies are common in CST; however, strategies often contain embedded communication skills. These skills can exist across strategies, and the Comskil Model seeks to make them explicit in these contexts. Separate from the skills are process tasks and cognitive appraisals that need to be addressed in teaching. The authors also describe how assessment practices foster concordance between skills taught and those assessed through careful coding of trainees' communication encounters and direct feedback.

Training faculty to facilitate communication skills training: development and evaluation of a workshop.

OBJECTIVE: To develop a workshop for training faculty to facilitate small group role play sessions for a communication skills training program and assess the impact of that workshop on the trainees' self-efficacy about facilitation skills. METHODS: A multi-specialty group of 33 attending physicians at a Comprehensive Cancer Center were trained in a Facilitating Communication Skills Training workshop in order to prepare them to facilitate small group role play with fellows and residents. The workshop curriculum was based on theory and literature on teaching communication skills. RESULTS: The workshop had a significant effect on participants' self-efficacy in facilitating communication skills training. At least 75% of participants reported feeling comfortable facilitating communication skills training small groups. CONCLUSION: This facilitation workshop was successful in providing participants with confidence to successfully facilitate small group role play sessions in communication skills training. PRACTICE IMPLICATIONS: In order to evaluate the effectiveness of communication skills training programs, it is important to have trained facilitators who adhere to a set of facilitation guidelines. Workshops on facilitation skills provide the background and practice time necessary as a first step in the training process.

Implications of Patient Portal Transparency in Oncology: Qualitative Interview Study on the Experiences of Patients, Oncologists, and Medical Informaticists.

BACKGROUND: Providing patients with unrestricted access to their electronic medical records through patient portals has impacted patient-provider communication and patients' personal health knowledge. However, little is known about how patient portals are used in oncology. OBJECTIVE: The aim of this study was to understand attitudes of the portal's adoption for oncology and to identify the advantages and disadvantages of using the portal to communicate and view medical information. METHODS: In-depth semistructured interviews were conducted with 60 participants: 35 patients, 13 oncologists, and 12 medical informaticists. Interviews were recorded, transcribed, and thematically analyzed to identify critical incidents and general attitudes encountered by participants. RESULTS: Two primary themes were discovered: (1) implementation practices influence attitudes, in which the decision-making and execution process of introducing portals throughout the hospital did not include the input of oncologists. Lack of oncologists' involvement led to a lack of knowledge about portal functionality, such as not knowing the time period when test results would be disclosed to patients; (2) perceptions of portals as communication tools varies by user type, meaning that each participant group (patients, oncologists, and medical informaticists) had varied opinions about how the portal should be used to transmit and receive information. Oncologists and medical informaticists had difficulty understanding one another's culture and communication processes in their fields, while patients had preferences for how they would like to receive communication, but it largely depended upon the type of test being disclosed. CONCLUSIONS: The majority of patients (54%, 19/35) who participated in this study viewed lab results or scan reports via the portal before being contacted by a clinician. Most were relatively comfortable with this manner of disclosure but still preferred face-to-face or telephone communication. Findings from this study indicate that portal education is needed for both patients and oncologists, especially when portals are implemented across entire health systems since highly specialized areas of medicine may have unique needs and uses. Patient portals in oncology can potentially alter the way diagnoses are delivered and how patients and oncologists communicate. Therefore, communication about the portal should be established during initial consultations so patients can decide whether they want to be informed in such a manner.

Primary Care Physicians' Support of Shared Decision Making for Different Cancer Screening Decisions.

BACKGROUND: Despite its widespread advocacy, shared decision making (SDM) is not routinely used for cancer screening. To better understand the implementation barriers, we describe primary care physicians' (PCPs') support for SDM across diverse cancer screening contexts. METHODS: Surveys were mailed to a random sample of USA-based PCPs. Using multivariable logistic regression analyses, we tested for associations of PCPs' support of SDM with the US Preventive Service Task Force (USPSTF) assigned recommendation grade, assessed whether the decision pertained to not screening older patients, and the PCPs' autonomous v. controlled motivation-orientation for using SDM. RESULTS: PCPs (n = 278) were, on average, aged 52 years, 38% female, and 69% white. Of these, 79% endorsed discussing screening benefits as very important to SDM; 64% for discussing risks; and 31% for agreeing with patient's opinion. PCPs were most likely to rate SDM as very important for colorectal cancer screening in adults aged 50-75 years (69%), and least likely for colorectal cancer screening in adults aged >85 years (34%). Regression results indicated the importance of PCPs' having autonomous or self-determined reasons for engaging in SDM (e.g., believing in the benefits of SDM) (OR = 2.29, 95% CI, 1.87 to 2.79). PCPs' support for SDM varied by USPSTF recommendation grade (overall contrast, X2 = 14.7; P = 0.0054), with support greatest for A-Grade recommendations. Support for SDM was lower in contexts where decisions pertained to not screening older patients (OR = 0.45, 95% CI, 0.35 to 0.56). LIMITATIONS: It is unknown whether PCPs' perceptions of the importance of SDM behaviors differs with specific screening decisions or the potential limited ability to generalize findings. CONCLUSIONS: Our results highlight the need to document SDM benefits and consider the specific contextual challenges, such as the level of uncertainty or whether evidence supports recommending/not recommending screening, when implementing SDM across an array of cancer screening contexts.

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.