[Prehabilitation through physical activity in oncology]. / Préhabilitation par l'activité physique en oncologie.

It has now been established that preoperative physical activity plays an essential role in minimizing postoperative complications. Patients who have undergone physical preparation recover their preoperative abilities more quickly. However, only about a third of those with access to such preparation report an improvement in their physical abilities. The modalities of intervention and follow-up, such as the training load and the generic format of the proposed sessions, seem to hinder patient participation in these programs, thus explaining the mixed results. In this context, it seems necessary to individualize prehabilitation in order to improve the functional capacities of people in this phase or in the phase of accelerated recovery after treatment or surgery.

Behaviour, barriers and facilitators of shared decision making in breast cancer surgical treatment: A qualitative systematic review using a 'Best Fit' framework approach.

BACKGROUND: Due to the diversity and high sensitivity of the treatment, there were difficulties and uncertainties in the breast cancer surgical decision-making process. We aimed to describe the patient's decision-making behaviour and shared decision-making (SDM)-related barriers and facilitators in breast cancer surgical treatment. METHODS: We searched eight databases for qualitative studies and mixed-method studies about breast cancer patients' surgical decision-making process from inception to March 2021. The quality of the studies was critically appraised by two researchers independently. We used a 'best fit framework approach' to analyze and synthesize the evidence. RESULTS: Twenty-eight qualitative studies and three mixed-method studies were included in this study. Four themes and 10 subthemes were extracted: (a) struggling with various considerations, (b) actual decision-making behaviours, (c) SDM not routinely implemented and (d) multiple facilitators and barriers to SDM. CONCLUSIONS: Patients had various considerations of breast surgery and SDM was not routinely implemented. There was a discrepancy between information exchange behaviours, value clarification, decision support utilization and SDM due to cognitive and behavioural biases. When individuals made surgical decisions, their behaviours were affected by individual-level and system-level factors. Therefore, healthcare providers and other stakeholders should constantly improve communication skills and collaboration, and emphasize the importance of decision support, so as to embed SDM into routine practice. PATIENT AND PUBLIC CONTRIBUTION: This systematic review was conducted as part of a wider research entitled: Breast cancer patients' actual participation roles in surgical decision making: a mixed method research. The results of this project helped us to better analyze and generalize patients' views.

Patients' experiences with shared decision-making in home-based palliative care - navigation through major life decisions.

BACKGROUND: This study addresses the issue of shared decision-making (SDM) in a Norwegian home-based palliative care setting. The significance of patient involvement in SDM is widely acknowledged, and many patients want to participate in decisions about care and treatment. Yet, it remains a need for more knowledge regarding the initiators and approaches of SDM in the context of home-based palliative care, particularly from the patients' perspective. The aim of this study is to understand patients' experiences and preferences for SDM in home-based palliative care, seeking to enhance the quality of care and direct the planning of healthcare services. METHODS: We used a qualitative explorative design. A hermeneutic approach was employed, and data was collected through in-dept interviews with 13 patients. RESULTS: The study uncovered an overarching theme of "Navigating to reach own decisions," comprising three sub-themes: "To be trapped in life without decisions to act on"; "To surrender to others and let others deal with decisions"; "To continue to be oneself without focusing on disease and decision-making". CONCLUSIONS: The findings underscore the need for flexible, person-centered approaches in SDM, tailored to the fluctuating health literacy and changing preferences of patients in palliative care settings. Our study contributes to the understanding of SDM in palliative care by highlighting how patients navigate the balance between autonomy and reliance on HCPs. Future research should explore how healthcare systems, including HCPs' roles in the system, can adapt to the patients' dynamic needs, to ensuring that SDM will remain a supportive and empowering process for patients at all stages of their disease.

Application of deep learning on mammographies to discriminate between low and high-risk DCIS for patient participation in active surveillance trials.

BACKGROUND: Ductal Carcinoma In Situ (DCIS) can progress to invasive breast cancer, but most DCIS lesions never will. Therefore, four clinical trials (COMET, LORIS, LORETTA, AND LORD) test whether active surveillance for women with low-risk Ductal carcinoma In Situ is safe (E. S. Hwang et al., BMJ Open, 9: e026797, 2019, A. Francis et al., Eur J Cancer. 51: 2296-2303, 2015, Chizuko Kanbayashi et al. The international collaboration of active surveillance trials for low-risk DCIS (LORIS, LORD, COMET, LORETTA),  L. E. Elshof et al., Eur J Cancer, 51, 1497-510, 2015). Low-risk is defined as grade I or II DCIS. Because DCIS grade is a major eligibility criteria in these trials, it would be very helpful to assess DCIS grade on mammography, informed by grade assessed on DCIS histopathology in pre-surgery biopsies, since surgery will not be performed on a significant number of patients participating in these trials. OBJECTIVE: To assess the performance and clinical utility of a convolutional neural network (CNN) in discriminating high-risk (grade III) DCIS and/or Invasive Breast Cancer (IBC) from low-risk (grade I/II) DCIS based on mammographic features. We explored whether the CNN could be used as a decision support tool, from excluding high-risk patients for active surveillance. METHODS: In this single centre retrospective study, 464 patients diagnosed with DCIS based on pre-surgery biopsy between 2000 and 2014 were included. The collection of mammography images was partitioned on a patient-level into two subsets, one for training containing 80% of cases (371 cases, 681 images) and 20% (93 cases, 173 images) for testing. A deep learning model based on the U-Net CNN was trained and validated on 681 two-dimensional mammograms. Classification performance was assessed with the Area Under the Curve (AUC) receiver operating characteristic and predictive values on the test set for predicting high risk DCIS-and high-risk DCIS and/ or IBC from low-risk DCIS. RESULTS: When classifying DCIS as high-risk, the deep learning network achieved a Positive Predictive Value (PPV) of 0.40, Negative Predictive Value (NPV) of 0.91 and an AUC of 0.72 on the test dataset. For distinguishing high-risk and/or upstaged DCIS (occult invasive breast cancer) from low-risk DCIS a PPV of 0.80, a NPV of 0.84 and an AUC of 0.76 were achieved. CONCLUSION: For both scenarios (DCIS grade I/II vs. III, DCIS grade I/II vs. III and/or IBC) AUCs were high, 0.72 and 0.76, respectively, concluding that our convolutional neural network can discriminate low-grade from high-grade DCIS.

Effects of a shared decision-making implementation programme on patient-centred communication in oncology-Secondary analysis of a randomised controlled trial.

BACKGROUND: There is a need for better implementation of patient-centred (PC) communication and shared decision-making (SDM) in routine cancer care. OBJECTIVE: The aim of this study was to assess whether a programme to implement SDM in oncology had effects on PC communication in clinical encounters. DESIGN: This study constitutes a secondary analysis of data derived from an implementation trial applying a stepped wedge design that, among other strategies, incorporated training and coaching to enhance the PC communication skills of physicians. SETTING AND PARTICIPANTS: We analysed audio recordings of clinical encounters collected in three departments of a comprehensive cancer centre in Germany before and after rolling out the implementation programme. MAIN VARIABLES STUDIED: We assessed the PC communication skills of physicians. MAIN OUTCOME MEASURES: Each recording was rated by two researchers using the German version of the Four Habits Coding Scheme (4HCS), an observer-based measure of PC communication. Interrater reliability of the outcome measure was acceptable but moderate. Demographic data of patients participating in audio recordings were analysed. METHODS: Data were analysed using descriptive statistics and linear mixed-effects models. RESULTS: In total, 146 encounters, 74 before and 72 after implementation, were evaluated. The mean age of patients was 57.1 years (SD = 13.8), 70.3% were female, the largest portion of patients had medium formal education (32.4%) and were (self-) employed (37.8%). No statistically significant effect of the implementation programme on the physicians' PC communication skills was found. DISCUSSION: The results indicate that the investigated programme to implement SDM in oncology, including training and coaching, had no effects on PC communication in clinical encounters. These results are in contrast to other studies that report the effects of specific training or coaching on PC communication. Reasons for the lack of effect include the short duration of our training compared to other studies, limited reliability and moderate interrater reliability of the 4HCS scale, limited reach of the intervention programme as well as the inclusion of physicians regardless of their exposure to the interventions. CONCLUSION: Further research is needed to develop implementation strategies that improve physicians' PC communication skills. PATIENT CONTRIBUTION: Data on patients and clinical encounters with patients and physicians were analysed. There was no other patient or public involvement.

Large language models as decision aids in neuro-oncology: a review of shared decision-making applications.

Shared decision-making (SDM) is crucial in neuro-oncology, fostering collaborations between patients and healthcare professionals to navigate treatment options. However, the complexity of neuro-oncological conditions and the cognitive and emotional burdens on patients present significant barriers to achieving effective SDM. This discussion explores the potential of large language models (LLMs) such as OpenAI's ChatGPT and Google's Bard to overcome these barriers, offering a means to enhance patient understanding and engagement in their care. LLMs, by providing accessible, personalized information, could support but not supplant the critical insights of healthcare professionals. The hypothesis suggests that patients, better informed through LLMs, may participate more actively in their treatment choices. Integrating LLMs into neuro-oncology requires navigating ethical considerations, including safeguarding patient data and ensuring informed consent, alongside the judicious use of AI technologies. Future efforts should focus on establishing ethical guidelines, adapting healthcare workflows, promoting patient-oriented research, and developing training programs for clinicians on the use of LLMs. Continuous evaluation of LLM applications will be vital to maintain their effectiveness and alignment with patient needs. Ultimately, this exploration contends that the thoughtful integration of LLMs into SDM processes could significantly enhance patient involvement and strengthen the patient-physician relationship in neuro-oncology care.

Impact of timing and format of patient decision aids for breast cancer patients on their involvement in and preparedness for decision making - the IMPACTT randomised controlled trial protocol.

BACKGROUND: After curative surgery for early-stage breast cancer, patients face a decision on whether to undergo surgery alone or to receive one or more adjuvant treatments, which may lower the risk of recurrence. Variations in survival outcomes are often marginal but there are differences in the side effects and other features of the options that patients may value differently. Hence, the patient's values and preferences are critical in determining what option to choose. It is well-researched that the use of shared decision making and patient decision aids can support this choice in a discussion between patient and clinician. However, it is still to be investigated what impact the timing and format of the patient decision aid have on shared decision making outcomes. In this trial, we aim to investigate the impact of a digital pre-consult compared to a paper-based in-consult patient decision aid on patients' involvement in shared decision making, decisional conflict and preparedness to make a decision. METHODS: The study is a randomised controlled trial with 204 patients at two Danish oncology outpatient clinics. Eligible patients are newly diagnosed with early-stage breast cancer and offered adjuvant treatments after curative surgery to lower the risk of recurrence. Participants will be randomised to receive either an in-consult paper-based patient decision aid or a pre-consult digital patient decision aid. Data collection includes patient and clinician-reported outcomes as well as observer-reported shared decision making based on audio recordings of the consultation. The primary outcome is the extent to which patients are engaged in a shared decision making process reported by the patient. Secondary aims include the length of consultation, preparation for decision making, preferred role in shared decision making and decisional conflict. DISCUSSION: This study is the first known randomised, controlled trial comparing a digital, pre-consult patient decision aid to an identical paper-based, in-consult patient decision aid. It will contribute evidence on the impact of patient decision aids in terms of investigating if pre-consult digital patient decisions aids compared to in-consult paper-based decision aids support the cancer patients in being better prepared for decision making. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05573022).

TBCRC 057: Survey about willingness to participate in cancer clinical trials during the pandemic.

BACKGROUND: Breast cancer patients experienced heightened anxiety during the pandemic. Also, modifications to clinical trial activities allowing for virtual platforms, local assessments, and greater flexibility were introduced to facilitate participation. We sought to evaluate the association between pandemic-related anxiety and willingness to participate in trials and how pandemic-era modifications to trial activities affect the decision to participate. METHODS: We conducted an online survey from August to September, 2021 of patients with breast cancer assessing pandemic-related anxiety; clinical trials knowledge and attitudes; willingness to participate during and before the pandemic; and how each modification affects the decision to participate. Fisher's exact tests evaluated differences in proportions and two-sample t-tests evaluated differences in means. The association of pandemic-related anxiety with a decline in willingness to participate during compared to prior to the pandemic was modeled using logistic regression. RESULTS: Among 385 respondents who completed the survey, 81% reported moderate-severe pandemic-related anxiety. Mean willingness to participate in a trial was lower during the pandemic than prior [2.97 (SD 1.17) vs. 3.10 (SD 1.09), (p < 0.001)]. Severe anxiety was associated with higher odds of diminished willingness to participate during the pandemic compared to prior (OR 5.07). Each of the modifications, with the exception of opting out of research-only blood tests, were endorsed by >50% of respondents as strategies that would increase their likelihood of deciding to participate. CONCLUSIONS: While pandemic-related anxiety was associated with diminished willingness to participate in trials, the leading reasons for reluctance to consider trial participation were unrelated to the pandemic but included worries about not getting the best treatment, side effects, and delaying care. Patients view trial modifications favorably, supporting continuation of these modifications, as endorsed by the National Cancer Institute and others.

Aligning organisational priorities and implementation science for cancer research.

BACKGROUND: The challenge of implementing evidence into routine clinical practice is well recognised and implementation science offers theories, models and frameworks to promote investigation into delivery of evidence-based care. Embedding implementation researchers into health systems is a novel approach to ensuring research is situated in day-to-day practice dilemmas. To optimise the value of embedded implementation researchers and resources, the aim of this study was to investigate stakeholders' views on opportunities for implementation science research in a cancer setting that holds potential to impact on care. The research objectives were to: 1) Establish stakeholder and theory informed organisation-level implementation science priorities and 2) Identify and prioritise a test case pilot implementation research project. METHODS: We undertook a qualitative study using semi-structured interviews. Participants held either a formal leadership role, were research active or a consumer advocate and affiliated with either a specialist cancer hospital or a cancer alliance of ten hospitals. Interview data were summarised and shared with participants prior to undertaking both thematic analysis, to identify priority areas for implementation research, and content analysis, to identify potential pilot implementation research projects. The selected pilot Implementation research project was prioritised using a synthesis of an organisational and implementation prioritisation framework - the organisational priority setting framework and APEASE framework. RESULTS: Thirty-one people participated between August 2022 and February 2023. Four themes were identified: 1) Integration of services to address organisational priorities e.g., tackling fragmented services; 2) Application of digital health interventions e.g., identifying the potential benefits of digital health interventions; 3) Identification of potential for implementation research, including deimplementation i.e., discontinuing ineffective or low value care and; 4) Focusing on direct patient engagement e.g., wider consumer awareness of the challenges in delivering cancer care. Six potential pilot implementation research projects were identified and the EMBED project, to support clinicians to refer appropriate patients with cancer for genetic testing, was selected using the synthesised prioritisation framework. CONCLUSIONS: Using a theory informed and structured approach the alignment between strategic organisational priorities and implementation research priorities can be identified. As a result, the implementation research focus can be placed on activities with the highest potential impact.

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.

BACKGROUND: Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy. METHODS: Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT. Data was analyzed using relational autonomy ethical theory and constant comparative analysis. RESULTS: The extent to which participants perceived themselves as having a choice to participate in early-phase cancer immunotherapy CTs was a central construct. Perceptions of choice varied according to whether participants characterized their experience as an act of desperation or as an opportunity to receive a novel treatment. Intersecting psychosocial and structural factors influenced participants' decision making about participating in early-phase cancer immunotherapy trials. These relational factors included: (1) being provided with hope; (2) having trust; (3) having the ability to withdraw; and (4) timing constraints. CONCLUSIONS: Findings highlight the continuum of perceived choice that exists among patients with cancer when considering participation in early-phase cancer immunotherapy CTs. All participants were interpreted as exhibiting some degree of relational autonomy within the psychosocial and structural context of early-phase CT decision making. This study offers insights into the intersection of cancer care delivery, personal beliefs and values, and established CT processes and structures that can inform future practices and policies associated with early-phase cancer immunotherapy CTs to better support patients in making informed decisions.

PC-PEP, a Comprehensive Daily Six-Month Home-Based Patient Empowerment Program Leads to Weight Loss in Men with Prostate Cancer: A Secondary Analysis of a Clinical Trial.

Background: The Prostate Cancer-Patient Empowerment Program (PC-PEP) is a six-month daily home-based program shown to improve mental health and urinary function. This secondary analysis explores weight loss in male PC-PEP participants. Methods: In a randomized clinical trial with 128 men undergoing curative prostate cancer (PC) treatment, 66 received 'early' PC-PEP, while 62 were assigned to the 'late' waitlist-control group, receiving 6 months of standard-of-care treatment followed by 6 months of PC-PEP. PC-PEP comprised 182 daily emails with video-based exercise and dietary (predominantly plant-based) education, live online events, and 30 min strength training routines (using body weight and elastic bands). Weight and height data were collected via online surveys (baseline, 6 months, and 12 months) including medical chart reviews. Adherence was tracked weekly. Results: No attrition or adverse events were reported. At 6 months, the early PC-PEP group experienced significant weight loss, averaging 2.7 kg (p < 0.001) compared to the waitlist-control group. Weight loss was noted in the late intervention group of PC-PEP, albeit less pronounced than in the early group. Early PC-PEP surgery patients lost on average 1.4 kg (SE = 0.65) from the trial's start to surgery day. High adherence to exercise and dietary recommendations was noted. Conclusions: PC-PEP led to significant weight loss in men undergoing curative prostate cancer treatment compared to standard-of-care.

Uncertainty tolerance among primary care physicians: Relationship to shared decision making-related perceptions, practices, and physician characteristics.

OBJECTIVE: Understand how physicians' uncertainty tolerance (UT) in clinical care relates to their personal characteristics, perceptions and practices regarding shared decision making (SDM). METHODS: As part of a trial of SDM training about colorectal cancer screening, primary care physicians (n = 67) completed measures of their uncertainty tolerance in medical practice (Anxiety subscale of the Physician's Reactions to Uncertainty Scale, PRUS-A), and their SDM self-efficacy (confidence in SDM skills). Patients (N = 466) completed measures of SDM (SDM Process scale) after a clinical visit. Bivariate regression analyses and multilevel regression analyses examined relationships. RESULTS: Higher UT was associated with greater physician age (p = .01) and years in practice (p = 0.015), but not sex or race. Higher UT was associated with greater SDM self-efficacy (p < 0.001), but not patient-reported SDM. CONCLUSION: Greater age and practice experience predict greater physician UT, suggesting that UT might be improved through training, while UT is associated with greater confidence in SDM, suggesting that improving UT might improve SDM. However, UT was unassociated with patient-reported SDM, raising the need for further studies of these relationships. PRACTICE IMPLICATIONS: Developing and implementing training interventions aimed at increasing physician UT may be a promising way to promote SDM in clinical care.

Question prompt list intervention for patients with advanced cancer: a systematic review and meta-analysis.

BACKGROUND: Enhanced communication in end-of-life care (EOL) improves preparation and treatment decisions for patients with advanced cancer, affecting their quality of life at the end of life. Question prompt list (QPL) has been shown to enhance physician-patient communication in patients with cancer, but there is a lack of systematic review and meta-analysis for those with advanced cancer. Enhanced communication in end-of-life care improves preparation and treatment decisions for patients with advanced cancer, affecting their quality of life at the end of life. OBJECTIVE: To review the effectiveness of QPL intervention on physician-patient communication and health outcomes during consultation in patients with advanced cancer. METHODS: CINAHL, Embase, Scopus, and PsycINFO databases were undertaken using inclusion criteria for relevant articles up to August 2021. Pooled standardized mean difference (SMD) and 95% confidence intervals (CIs) were calculated using random-effects models. We used the Cochrane risk-of-bias assessment tool and modified Jadad scale to assess the quality of the studies. RESULTS: Seven RCTs with 1059 participants were included, of which six studies were eligible for the meta-analysis. The pooled meta-analysis results indicated that QPL in patients with advanced cancer had a significant positive effect on the total number of questions asked (SMD, 0.73; 95% CI, 0.28 to 1.18; I2 = 83%) and on the patients' expectations for the future (SMD, 0.67; 95% CI, 0.08 to 1.25; I2 = 88%). There were no significant improvements in health-related outcomes such as end of life, anxiety, and quality of life. CONCLUSIONS: Using QPL in advanced cancer consultations boosts patient questions which helps communication but not health-related indicators. Optimal results depend on full reading, but timing varies. Future research should examine the relationship between communication and health outcomes, including patient/physician behavior and social context.

A systematic review of the effectiveness of decision making interventions on increasing perceptions of shared decision making occurring in advanced cancer consultations.

OBJECTIVE: To determine how decision making interventions for use in advanced cancer treatment consultations function and whether they increase perceptions of shared decision making (SDM) behaviours within consultations. METHODS: A systematic search of five literature databases was conducted. Evaluations of decision making interventions where participants faced active treatment decisions for stage 4 or otherwise incurable cancer were included. Intervention descriptions were coded using Behaviour Change Techniques (BCTs) to provide a narrative of how the interventions function. A narrative synthesis of interventions effect on perceptions of SDM behaviours compared to usual care was conducted. RESULTS: Four studies presenting different interventions were included. Education, training, modelling and enablement intervention functions were identified. Oncologist SDM training alone and combined with a patient communication aid demonstrated the only significant effect (p < 0.05) on SDM behaviours in advanced cancer consultations. CONCLUSION: Healthcare professional (HCP) SDM training which includes modelling and enablement functions may be effective in increasing clinician motivation, capability and opportunity to facilitate SDM in advanced cancer consultations. PRACTICE IMPLICATIONS: Implementing HCP SDM training into practice may encourage greater uptake of SDM which may lead to treatment decisions concordant with the goals of care of people with advanced cancer.

Shared decision-making and its influencing factors among parents of children with cancer in China: A cross-sectional study.

PURPOSE: This study aimed at exploring SDM implementation and its influencing factors, and preferences towards SDM among parents of children with cancer in China. DESIGN AND METHODS: This cross-sectional study recruited 204 participants from 2 grade-A tertiary hospitals in Guangzhou, China. The preferences towards decision-making, the status of SDM were measured by CPS-P and SDM-Q-9. The nurse support were measure by NPST, the needs of parents were measured by Questionnaire for Needs of Parents Whose Children are in PICU, and sociodemographic and disease-related questionnaires were used to investigate general information of children and parents. Descriptive statistics, univariate analysis, and multivariable linear regression were used for data analysis. RESULTS: Of 204 participants, about half of parents (55.4 %) tended to choose SDM, however, 40.2 % of them still show passive attitudes. The mean SDM-Q-9 score was 31.07 ± 8.74, and the result showed that age (ß = 2.480, P＜0.05), relapse (ß = 4.407, P＜0.01), course of disease (ß = -5.213, P＜0.01), relationships with doctors (ß = -4.05, P＜0.05), trust in doctors (ß = -2.796, P＜0.05), and communication and information support from nurses (ß = 0.651, P＜0.01) were the main factors influencing SDM for parents. CONCLUSIONS: Over half of Chinese parents tended to choose SDM, but their real participation in SDM is unsatisfactory. Parents who were older, had good relationships with doctors, trusted in doctors, received more communication and information support from nurses, and whose children had shorter course of disease, suffered relapses, participated in SDM better.

How does patient-centered communication influence patient trust?: The roles of patient participation and patient preference.

OBJECTIVE: The aim of this study was to examine the effects of patient-centered communication, patient participation, and patient preference on patient trust in the context of China. METHODS: A cross-sectional survey was conducted involving 217 cancer patients in China. Mediation and moderation analyses were performed to examine the relationships among the study variables. RESULTS: First, patient-centered communication increased patient participation in decision-making, which, in turn, enhanced patient trust. Second, patient-centered communication did not have a direct effect on patient trust. Third, patient preference for a passive role in decision-making weakened the relationship between patient participation and patient trust. CONCLUSION: The results underscore the significant effect of facilitating patient participation in linking patient-centered communication to patient trust. However, medical communication should also respond to patients' preferred roles in the decision-making process. PRACTICE IMPLICATIONS: Doctors should provide patients with opportunities to ask questions and express their concerns. In addition, they should evaluate patients' preferred degree of involvement before inviting them to contribute so as to respect their preferences and values.

Shared decision making with breast cancer patients - does it work? Results of the cluster-randomized, multicenter DBCG RT SDM trial.

BACKGROUND AND PURPOSE: Shared decision making (SDM) is a patient engaging process advocated especially for preference-sensitive decisions, such as adjuvant treatment after breast cancer. An increasing call for patient engagement in decision making highlights the need for a systematic SDM approach. The objective of this trial was to investigate whether the Decision Helper (DH), an in-consultation patient decision aid, increases patient engagement in decisions regarding adjuvant whole breast irradiation. MATERIAL AND METHODS: Oncologists at four radiotherapy units were randomized to practice SDM using the DH versus usual practice. Patient candidates for adjuvant whole breast irradiation after breast conserving surgery for node-negative breast cancer were eligible. The primary endpoint was patient-reported engagement in the decision process assessed with the Shared Decision Making Questionnaire (SDM-Q-9) (range 0-100, 4 points difference considered clinical relevant). Other endpoints included oncologist-reported patient engagement, decisional conflict, fear of cancer recurrence, and decision regret after 6 months. RESULTS: Of the 674 included patients, 635 (94.2%) completed the SDM-Q-9. Patients in the intervention group reported higher level of engagement (median 80; IQR 68.9 to 94.4) than the control group (71.1; IQR 55.6 to 82.2; p < 0.0001). Oncologist-reported patient engagement was higher in the invention group (93.3; IQR 82.2 to 100) compared to control group (73.3; IQR 60.0 to 84.4) (p < 0.0001). CONCLUSION: Patient engagement in medical decision making was significantly improved with the use of an in-consultation patient decision aid compared to standard. The DH on adjuvant whole breast irradiation is now recommended as standard of care in the Danish guideline.

Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention.

BACKGROUND: Patients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making (SDM) models help to understand considerations that influence patients' decision. Discussion of patient values is essential to SDM, but such communication is often limited in this context and may require new interventions. The OnVaCT intervention, consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists, was previously developed to support SDM. This study aimed to qualitatively explore associations between patient values that are discussed between patients and oncologists during consultations about potential participation in early phase clinical trials before and after implementation of the OnVaCT intervention. METHODS: This study is part of a prospective multicentre nonrandomized controlled clinical trial and had a between-subjects design: pre-intervention patients received usual care, while post-intervention patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients' initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached. RESULTS: Data saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-intervention and 15 post-intervention). The analysis revealed the values: hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, acceptance of one's fate, and humanity. Patients in the pre-intervention phase tended to express values briefly and spontaneously. Oncologists acknowledged the importance of patients' values, but generally only gave 'contrasting' examples of why some accept and others refuse to participate in trials. In the post-intervention phase, many oncologists referred to the OnVaCT and/or asked follow-up questions, while patients used longer phrases that combined multiple values, sometimes clearly indicating their weighing. CONCLUSIONS: While all values were recognized in both study phases, our results have highlighted the different communication patterns around patient values in SDM for potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study therefore provides a first (qualitative) indication that the OnVaCT intervention may support patients and oncologists in discussing their values. TRIAL REGISTRATION: Netherlands Trial Registry: NL7335, registered on July 17, 2018.

Patient readiness for shared decision making about treatment: Conceptualisation and development of the ReadySDM.

INTRODUCTION: Shared decision making (SDM) requires an active role of both clinicians and patients. We aimed to conceptualise patient readiness for SDM about treatment, and to develop a patient questionnaire to assess readiness. METHODS: We used the results of a scoping review and a qualitative study to inform the patient readiness construct. We conducted five additional rounds of data collection to finalise the construct definition and develop the Patient Readiness for SDM Questionnaire (ReadySDM ) in an oncological setting: (1) longitudinal interviews with patients with cancer during and after a treatment decision-making process; (2) a pilot study among experts, clinicians, and patients for feedback on the concept and items; (3) a field test among (former) patients with cancer to test item format and content validity, and to reduce the number of items; (4) cognitive interviews with people with low literacy to test the comprehensibility of the questionnaire; and (5) a field test among (former) patients who faced a cancer treatment decision in the last year, to test the content validity of the final version of the questionnaire. RESULTS: A total of 251 people participated in the various rounds of data collection. We identified eight elements of patient readiness for SDM about treatment: (1) understanding of and attitude towards SDM; (2) information skills; (3) skills in communicating and claiming space; (4) self-awareness; (5) consideration skills; (6) self-efficacy; (7) emotional distress; and (8) experienced time. We developed the 20-item ReadySDM to retrospectively measure these elements in an oncological setting. CONCLUSION: We conducted a thorough procedure to conceptualise patient readiness and to develop the ReadySDM . The questionnaire aims to provide novel insights into ways to enhance SDM in daily practice. PATIENT OR PUBLIC CONTRIBUTION: Multiple people with lived experience were involved in various phases of the study. They were asked for input on the study design, the conceptualisation of readiness, and the development of the questionnaire.

The Effects of Patient-Centered Communication on Patient Engagement, Health-Related Quality of Life, Service Quality Perception and Patient Satisfaction in Patients with Cancer: A Cross-Sectional Study in Türkiye.

INTRODUCTION: Patient-centered communication is a type of communication that takes place between the provider and the patient. OBJECTIVES: It is aimed to reveal the effects of patient-centered communication on patient engagement, health-related quality of life, perception of service quality and patient satisfaction. METHOD: The study was conducted by applying multiple regression analysis to the data obtained from 312 patients with cancer treated in a training and research hospital affiliated to the Ministry of Health in Diyarbakir, Türkiye. RESULTS: More than half of the patients were female and had stage 4 cancer. Different types of cancer were detected (breast cancer, cancer of the digestive organs, lymphatic and hematopoietic cancer, cancer of the genital organs, cancer of the respiratory organs, etc.). It can be stated that the average values obtained by patients from patient-centered communication and its sub-dimensions are high. There are positive, moderate and low and significant relationships between the overall patient-centered communication and patient engagement, patient satisfaction, service quality perception and quality of life. It was statistically revealed that patient-centered communication positively affected patient engagement, health-related quality of life, service quality perception, and patient satisfaction. CONCLUSION: Patient-centered communication positively affects various short and medium-term health outcomes and this study offers suggestions for improving patient-provider communication.