Development of Web-Based Education Modules to Improve Carer Engagement in Cancer Care: Design and User Experience Evaluation of the e-Triadic Oncology (eTRIO) Modules for Clinicians, Patients, and Carers.

BACKGROUND: Carers often assume key roles in cancer care. However, many carers report feeling disempowered and ill-equipped to support patients. Our group published evidence-based guidelines (the Triadic Oncology [TRIO] Guidelines) to improve oncology clinician engagement with carers and the management of challenging situations involving carers. OBJECTIVE: To facilitate implementation of the TRIO Guidelines in clinical practice, we aimed to develop, iteratively refine, and conduct user testing of a suite of evidence-based and interactive web-based education modules for oncology clinicians (e-Triadic Oncology [eTRIO]), patients with cancer, and carers (eTRIO for Patients and Carers [eTRIO-pc]). These were designed to improve carer involvement, communication, and shared decision-making in the cancer management setting. METHODS: The eTRIO education modules were based on extensive research, including systematic reviews, qualitative interviews, and consultation analyses. Guided by the person-based approach, module content and design were reviewed by an expert advisory group comprising academic and clinical experts (n=13) and consumers (n=5); content and design were continuously and iteratively refined. User experience testing (including "think-aloud" interviews and administration of the System Usability Scale [SUS]) of the modules was completed by additional clinicians (n=5), patients (n=3), and carers (n=3). RESULTS: The final clinician module comprises 14 sections, requires approximately 1.5 to 2 hours to complete, and covers topics such as carer-inclusive communication and practices; supporting carer needs; and managing carer dominance, anger, and conflicting patient-carer wishes. The usability of the module was rated by 5 clinicians, with a mean SUS score of 75 (SD 5.3), which is interpreted as good. Clinicians often desired information in a concise format, divided into small "snackable" sections that could be easily recommenced if they were interrupted. The carer module features 11 sections; requires approximately 1.5 hours to complete; and includes topics such as the importance of carers, carer roles during consultations, and advocating for the patient. The patient module is an adaptation of the relevant carer module sections, comprising 7 sections and requiring 1 hour to complete. The average SUS score as rated by 6 patients and carers was 78 (SD 16.2), which is interpreted as good. Interactive activities, clinical vignette videos, and reflective learning exercises are incorporated into all modules. Patient and carer consumer advisers advocated for empathetic content and tone throughout their modules, with an easy-to-read and navigable module interface. CONCLUSIONS: The eTRIO suite of modules were rigorously developed using a person-based design methodology to meet the unique information needs and learning requirements of clinicians, patients, and carers, with the goal of improving effective and supportive carer involvement in cancer consultations and cancer care.

An online intervention to improve oncology health professional self-efficacy in communicating with carers: Hybrid effectiveness-implementation evaluation of the eTRIO program.

OBJECTIVES: Many oncology health professionals (HPs) report communicating with carers as complex; and receive limited carer-relevant training. We developed an online HP education program for supporting and managing carer involvement (eTRIO). We aimed to assess whether HPs' self-efficacy in carer communication, knowledge, and decision-making preferences improve following eTRIO. Satisfaction and implementation potential were assessed. METHODS: This type 1 hybrid effectiveness-implementation study used a pre-post single arm intervention design. HPs completed baseline measures, the eTRIO online module, and measures at 1- and 12-weeks post-intervention. Measures included: self-efficacy in carer communication (13-items), applied knowledge (7-items), preference for carer involvement in decisions (1-item). Fifteen of participants completed feedback interviews which underwent thematic analysis. User analytics were collected and analysed. RESULTS: Fifty-six HPs completed baseline measures, 42 completed post- and follow-up measures. At baseline mean self-efficacy score was 88. HPs showed a statistically significant increase in self-efficacy post-intervention (mean = 105.8, CI [12.99, 20.47]), maintained at 12-weeks (mean = 101.1, CI [8.00, 15.72]). There were no changes in knowledge or decision-making preferences. Program engagement and satisfaction were high, 86.7% participants rated eTRIO as very/extremely helpful. CONCLUSIONS AND PRACTICE IMPLICATIONS: eTRIO provided HPs with confidence to effectively engage with carers and manage complex situations such as family dominance. These gains are noteworthy, as conflict with families/carers contributes to HP burnout.

An Analysis of Incident Reports Related to Electronic Medication Management: How They Change Over Time.

OBJECTIVE: Electronic medication management (EMM) systems have been shown to introduce new patient safety risks that were not possible, or unlikely to occur, with the use of paper charts. Our aim was to examine the factors that contribute to EMM-related incidents and how these incidents change over time with ongoing EMM use. METHODS: Incidents reported at 3 hospitals between January 1, 2010, and December 31, 2019, were extracted using a keyword search and then screened to identify EMM-related reports. Data contained in EMM-related incident reports were then classified as unsafe acts made by users and the latent conditions contributing to each incident. RESULTS: In our sample, 444 incident reports were determined to be EMM related. Commission errors were the most frequent unsafe act reported by users (n = 298), whereas workarounds were reported in only 13 reports. User latent conditions (n = 207) were described in the highest number of incident reports, followed by conditions related to the organization (n = 200) and EMM design (n = 184). Over time, user unfamiliarity with the system remained a key contributor to reported incidents. Although fewer articles to electronic transfer errors were reported over time, incident reports related to the transfer of information between different computerized systems increased as hospitals adopted more clinical information systems. CONCLUSIONS: Electronic medication management-related incidents continue to occur years after EMM implementation and are driven by design, user, and organizational conditions. Although factors contribute to reported incidents in varying degrees over time, some factors are persistent and highlight the importance of continuously improving the EMM system and its use.

The impact of management option on out-of-pocket costs and perceived financial burden among men with localised prostate cancer in Australia within 6 months of diagnosis.

Objective This study aimed to quantify the out-of-pocket (OOP) costs and perceived financial burden among Australian men with localised prostate cancer in the first 6 months after diagnosis, by primary management option. Methods This cost-analysis quantified OOP costs using administrative claims data and self-reported survey data. Financial burden was assessed using the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool. Participants were recruited into a randomised control trial from public or private treatment centres in Victoria and Queensland. Generalised linear models were used to predict OOP costs and COST-FACIT scores. Results Median total OOP costs within 6 months of diagnosis for 256 Australian patients with localised prostate cancer was A$1172 (A$343-2548). Up to 50% of the sample reported A$0 costs for most medical services. Compared with those managed with active surveillance, men having active treatment had 6.4 (95% CI: 3.2-12.7) times greater total OOP costs. Management option, higher Gleason score at diagnosis and having multiple comorbidities were significant predictors of higher OOP costs. Overall high scores on the COST-FACIT indicated low levels of financial burden for the entire sample. Conclusion Largely attributable to being managed with active surveillance, Australian men diagnosed with localised prostate cancer reported relatively low OOP costs and financial burden in the first 6 months post-diagnosis. Together with clinical outcomes, clinicians can use this up to date evidence on costs and perceived financial burdens to assist localised prostate cancer patients and their families make informed decisions about their preferred management option.

Co-designing an online treatment decision aid for men with low-risk prostate cancer: Navigate.

Objectives: To develop an online treatment decision aid (OTDA) to assist patients with low-risk prostate cancer (LRPC) and their partners in making treatment decisions. Patients and methods: Navigate, an OTDA for LRPC, was rigorously co-designed by patients with a confirmed diagnosis or at risk of LRPC and their partners, clinicians, researchers and website designers/developers. A theoretical model guided the development process. A mixed methods approach was used incorporating (1) evidence for essential design elements for OTDAs; (2) evidence for treatment options for LRPC; (3) an iterative co-design process involving stakeholder workshops and prototype review; and (4) expert rating using the International Patient Decision Aid Standards (IPDAS). Three co-design workshops with potential users (n = 12) and research and web-design team members (n = 10) were conducted. Results from each workshop informed OTDA modifications to the OTDA for testing in the subsequent workshop. Clinician (n = 6) and consumer (n = 9) feedback on usability and content on the penultimate version was collected. Results: The initial workshops identified key content and design features that were incorporated into the draft OTDA, re-workshopped and incorporated into the penultimate OTDA. Expert feedback on usability and content was also incorporated into the final OTDA. The final OTDA was deemed comprehensive, clear and appropriate and met all IPDAS criteria. Conclusion: Navigate is an interactive and acceptable OTDA for Australian men with LRPC designed by men for men using a co-design methodology. The effectiveness of Navigate in assisting patient decision-making is currently being assessed in a randomised controlled trial with patients with LRPC and their partners.

Stakeholder perspectives on the impact of COVID-19 on oncology services: a qualitative study.

BACKGROUND: As COVID-19 spread across the globe, cancer services were required to rapidly pivot to minimise risks without compromising outcomes for patients or staff. The aim of this study was to document changes to oncology services as a result of COVID-19 from the perspectives of both providers and receivers of care during the initial phase of the pandemic. METHODS: Participants were recruited between June and December 2020 through an email invitation via professional or consumer organisations, two hospital-based oncology services and snowballing. Semi-structured interviews focused on health service changes and their impacts, which were then analysed by thematic analysis. RESULTS: Thirty-two patients, 16 carers and 29 health professionals were recruited. Fifteen patients (n = 47%) had localised disease, and 19 (n = 59%) were currently receiving treatment. Oncology staff included oncologists, palliative care physicians, nurses, allied health and psychosocial practitioners. Four themes arose from the data: safety, increased stress and burnout, communication challenges and quality of cancer care. CONCLUSIONS: There is an ongoing need for cancer-specific information from a single, trusted source to inform medical practitioners and patients/carers. More data are required to inform evidence-based guidelines for cancer care during future pandemics. All stakeholders require ongoing support to avoid stress and burnout.

What is the optimal tool for measuring abortion stigma? A systematic review.

PURPOSE: Abortion stigma is a barrier to accessing and delivering comprehensive, sustainable healthcare. This study aimed to systematically identify measures of abortion stigma, and assess their psychometric properties and uses. MATERIALS AND METHODS: The systematic review was preregistered with PROSPERO (ID#127339) and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Eight databases were screened for articles measuring abortion stigma. Data were extracted by four researchers and checked for accuracy by two reviewers. Psychometric properties were assessed with COSMIN guidelines. RESULTS: Of 102 articles reviewed, 21 reported original measures of abortion stigma. Instruments assessed individual and community level stigma for people who have had an abortion (n = 8), healthcare professionals (n = 4), and the public (n = 9), and predominantly originated from the United States (U.S.). Measures varied in structure, use, and comprehensiveness of psychometric properties. On psychometric properties, the Individual Level Abortion Stigma scale and Abortion Provider Stigma Scale - Revised performed best for individual-level stigma and the Stigmatising Attitudes, Beliefs and Actions Scale for community-level stigma. CONCLUSION: Gaps in abortion stigma measurement include geography, conceptualisation, and structural-level stigma. Continued development and testing of tools and methods for measuring abortion stigma is needed.

A range of methods are available to measure abortion stigma, however with gaps in psychometrics, geography, and structural-level stigma. Continued development and testing of tools measuring abortion stigma is required for valid and reliable measurement, models, and intervention.

Positive relations between sexual quality of life and satisfaction with healthcare in women living with HIV and/or HCV: Results from a multicountry study.

INTRODUCTION: The sexual quality of life is a neglected concern in women living with HIV (WHIV) or with HCV (WHCV), which can further be affected by their experience with stigma, social instability, fear of transmission and reduced access to treatment. The objective of this study was to identify sociodemographic, psychosocial, and behavioural factors associated with sexual quality of life (SQoL) in this study group. METHODS: Between December 2017 and December 2018, PROQoL-Sex Life questionnaire was administered to 404 WHIV and WHCV in five countries. PROQoL-SQoL consists of four dimensions: positive sexual perception (Psp), stigma and social distress (Sti), soft sexual practices (Sof), sexual practices with a partner (Sp), all of which were scored from 0 to 100 and considered as main outcomes, lower scores mean better sexual quality of life. Linear mixed effects models were used to evaluate the association with sociodemographic and psychosocial factors. RESULTS: Of the participants analyzed, 191 were living with HCV, 180 with HIV and 33 with HIV and HCV, median age was 48. Among WHIV, a higher satisfaction with health care, and talking about sexuality with healthcare workers were associated with lower scores in all the dimensions of the SQoL, while psychoactive substance use was associated with lower scores of Sti and Sof. Moreover, higher satisfaction with health care, talking about sexuality with healthcare workers, and psychoactive substance use (except cocaine use) in WHCV were associated with lower scores in Psp, Sti, and Sof. Besides, cocaine use was associated with higher scores of Sof. CONCLUSION: This study highlighted strong relationship between the quality of health care, and psychoactive substance use (except cocaine) and the sexual quality of life in WHIV and WHCV in these five countries. These findings draw attention to the different interventions that can be proposed for improving the sexual quality of life.

Empowering family carers of people with multimorbidity as partners in chronic health care: Insights from health professionals.

OBJECTIVES: People living with multimorbidity often rely on the support of informal family carers, yet challenges frequently arise when carers of people with multimorbidity (PwM) interact with health professionals (HPs) and healthcare systems. This study aimed to provide insights into the experiences and challenges involved in working with carers of PwM, from HPs' perspectives. METHODS: Twenty-one HPs (11 doctors, 5 nurses and 5 allied health professionals) from varying specialities participated in semi-structured interviews. Interviews were transcribed and qualitatively analysed using thematic analysis. RESULTS: Five themes were identified: carer involvement makes multimorbidity easier to manage, differing views on HP's responsibilities to carers, multimorbidity makes management harder for HPs, strategies to support carers of PwM, and multimorbidity is one aspect of complexity. CONCLUSIONS: HPs recognise unique needs of carers of PwM, yet perceive challenges addressing these needs and supporting this commonly overlooked group. PRACTICE IMPLICATIONS: The unmet needs of carers of PwM that HPs identified in this study suggest pathways for future improvements and interventions, including HP education and training, and appropriate referral pathways for carers of PwM to access supportive services. Underpinning these findings is the need for greater recognition and respect for the critical work of family carers in healthcare.

Women with gynaecological cancer awaiting radiotherapy: Self-reported wellbeing, general psychological distress, symptom distress, sexual function, and supportive care needs.

OBJECTIVE: To better serve women with gynaecological cancers, we need a sound understanding of their health, wellbeing and needs. This study sought to explore these issues in a sample of Australian women before commencing curative radiotherapy. METHODS: We undertook a secondary analysis of baseline data from a supportive care trial (n = 311). Descriptive statistics were used to summarise responses to measures of wellbeing, general psychological distress, symptom distress, sexual function and vaginal changes, and supportive care needs. Pre-specified regression models were used to examine sources of variation in wellbeing and sexual function. RESULTS: Women reported lower emotional, functional and physical wellbeing than population norms (all p < 0.001). The prevalence of general psychological distress was 31% (95% CI 26-36%). Distress caused by physical symptoms was typically low. Health system and information needs comprised eight of the top ten moderate-to-high supportive care needs. Most women reported no change in interest for physical contact or sex compared to pre-diagnosis, but some sexually active women (16-24%) reported smaller vaginal size, increased dryness, and more pain on intercourse. General psychological distress was a robust marker of poorer wellbeing and sexual function. CONCLUSIONS: Before radiotherapy, a substantial minority of women with gynaecological cancers experience general psychological distress, reduced wellbeing and moderate-to-high health system and information needs. A model of comprehensive care incorporating assessment of unmet needs, general psychological distress, and sexual issues is recommended. Healthcare providers may require training to elicit and respond to a constellation of interrelated issues and access relevant services for women requiring additional support.

Psychometric assessment of the Concerns about Late Effects in Oncology Questionnaire (CLEO) among female breast cancer survivors.

OBJECTIVE: The Concerns about Late Effects in Oncology (CLEO) questionnaire was developed to measure concerns cancer survivors may have about late effects. The current study sought to assess the Concerns about Late Effects in Oncology's (CLEO) psychometric properties - factor structure, construct validity, discriminatory power, and internal consistency. METHODS: 147 breast cancer survivors completed a survey. Factor structure was determined by exploratory factor analysis (EFA). Construct validity was assessed against fear of cancer recurrence, anxiety, depression, quality of life, and neuroticism. Discriminatory power was assessed against participants' age and clinical characteristics. RESULTS: The EFA confirmed a 4-factor structure; health professionals' support, psychological impacts, adapting, and daily functional impacts. There was only partial support for construct validity and discriminatory power. The CLEO demonstrated excellent internal consistency, with an overall Cronbach's α = 0.87 (health professionals' support: α = 0.89, psychological impacts: α = 0.93, adapting: α = 0.82, and daily functional impacts: α = 0.89). CONCLUSION: The findings suggest further development of the CLEO should focus on the psychological and functional impacts of late effects. PRACTICE IMPLICATIONS: Use of the CLEO may enhance communication about the impact of late effects, ensuring earlier identification and management of late effects in this population.

Stakeholder perspectives of system-related errors: Types, contributing factors, and consequences.

BACKGROUND: Despite growing evidence of the benefits of electronic medication management systems (EMMS), research has also identified a range of new safety risks linked with their use. There is limited qualitative research focusing on system-related errors that result from use of EMMS. The aim of this study was to explore in-depth stakeholders' perceptions and experiences of system-related errors. METHODS: Semi-structured interviews were conducted with EMMS users and other relevant staff (e.g. supporting roles in EMMS) across a local health district in Sydney, Australia. Analysis was conducted iteratively using a general inductive approach, and then mapped to Reason's accident causation model, where codes were categorized as 1) unsafe acts (i.e. what error occurred), 2) latent conditions (i.e. what factors contributed to errors), and 3) consequences resulting from the error. RESULTS: Twenty-five participants were interviewed between September 2020 and May 2021. Participants most frequently described omission errors (e.g. failure to check for duplicate orders) as unsafe acts, although commission errors and workarounds were also reported. Poor EMMS design was reported to be a significant workplace factor contributing to system-related errors, however participants also described user factors, such as an overreliance on the system, and organizational factors, such as system downtime, as contributing to errors. Reported consequences of system-related errors included medication errors, but also impacts to the EMMS and on workers. CONCLUSIONS: EMMS design is a significant contributor to system-related errors, but this research showed that user and organizational factors are also at play. As these factors are not independent, minimizing system-related errors requires a multi-faceted approach, where mitigation strategies target not only the EMMS, but also the context in which the system has been implemented.

Psychological outcomes in advanced cancer patients after receiving genomic tumor profiling results.

BACKGROUND: Comprehensive tumor genomic profiling (CGP) offers hope for personalized treatment for cancer patients when other treatment options have been exhausted. However, receipt of nonactionable or ambiguous results could be an ongoing source of distress. We investigated patterns of hope, anxiety, depression, and CGP-specific anxiety in advanced cancer patients after receiving CGP results and 2-3 months later. METHOD: Participants were enrolled in a longitudinal psychosocial substudy, embedded in the Molecular Screening and Therapeutics Program, and had advanced solid cancers of any histological type with sufficient and accessible tissue for CGP. At T0 (before receiving CGP results), 1,431 participants completed sociodemographic, disease and psychosocial measures. At T1 (1-4 weeks after receiving CGP results) and T2 (2-3 months post-T1), 374 participants completed psychological outcome measures. Predictors of outcomes at T2 were identified using multinomial logistic regression. RESULTS: Approximately 75% of participants did not experience significant hopelessness or distress at T1 and T2. Hope decreased by T2, yet general anxiety and CGP-specific anxiety also decreased. Receiving actionable results did not impact psychological outcomes at T2. At T2, lower hope, and higher anxiety, depression and CGP-specific anxiety were associated with lower self-efficacy. Psychological and demographic factors (age, socioeconomic status, language, medical occupation, urban living, family history of cancer) independently predicted one or more psychological trajectories. Worse health status and perceived susceptibility to cancer progression predicted hope and anxiety trajectories. CONCLUSION: Further research on interventions to best support patients undergoing CGP with high anxiety, hopelessness, fear of cancer progression, and poorer health is urgently needed. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Psychological predictors of cancer patients' and their relatives' attitudes towards the return of genomic sequencing results.

This study assessed the psychological predictors of attitudes toward the return of germline genomic sequencing results in cancer patients and their biological relatives with a likely genetic basis for their cancer diagnosis, who completed a questionnaire prior to undergoing genomic sequencing. Of 602 probands and relatives, 94% of probands and 89% of relatives thought people would like to be informed about single-gene conditions for which there is prevention or treatment. Amongst relatives, this view was associated with higher perceived susceptibility and self-efficacy. Probands (66%) and relatives (59%) thought people would be interested in learning about single-gene conditions for which there is no prevention or treatment. Amongst probands, this view was associated with lower tolerance of uncertainty and amongst relatives with higher self-efficacy. Probands (92%) and relatives (90%) thought people would like to be informed about polygenic conditions that can have a major impact on health. Amongst probands this view was associated with lower perceived susceptibility of cancer recurrence, and amongst relatives, with higher perceived susceptibility and self-efficacy. Probands (86%) and relatives (86%) thought that people would like to be informed about polygenic conditions that can have a lower impact on health, and this view was associated with a lower perceived susceptibility of recurrence amongst probands. In conclusion, these findings show that individuals' attitudes about the return of results depend on the perceived utility of different types of tests. Therefore, individuals need to gain a clear understanding of test utility, and appropriate consent processes are required to achieve informed choices.

Preferences for return of germline genome sequencing results for cancer patients and their genetic relatives in a research setting.

Germline genome sequencing (GS) holds great promise for cancer prevention by identifying cancer risk and guiding prevention strategies, however research evidence is mixed regarding patient preferences for receiving GS results. The aim of this study was to discern preferences for return of results by cancer patients who have actually undergone GS. We conducted a mixed methods study with a cohort of cancer probands (n = 335) and their genetic relatives (n = 199) undergoing GS in a research setting. Both groups completed surveys when giving consent. A subset of participants (n = 40) completed semi-structured interviews. A significantly higher percentage of probands thought people would like to be informed about genetic conditions for which there is prevention or treatment that can change cancer risk compared to conditions for which there is no prevention or treatment (93% [311] versus 65% [216]; p < 0.001). Similar results were obtained for relatives (91% [180] versus 61% [121]; p < 0.001). Themes identified in the analysis of interviews were: (1) Recognised benefits of GS, (2) Balancing benefits with risks, (3) Uncertain results are perceived as unhelpful and (4) Competing obligations. While utility was an important discriminator in what was seen as valuable for this cohort, there was a variety of responses. In view of varied participant preferences regarding return of results, it is important to ensure patient understanding of test validity and identify individual choices at the time of consent to GS. The nature and value of the information, and a contextual understanding of researcher obligations should guide result return.

Psychological impact of comprehensive tumor genomic profiling results for advanced cancer patients.

OBJECTIVE: Comprehensive tumor genomic profiling (CTGP) is increasingly used to personalize treatments, providing hope, but potentially disappointment, for patients. We explored psychological outcomes in patients with advanced, incurable cancer, after receiving CTGP results. METHODS: Participants with advanced, incurable cancer (n = 560, mean age 56, 43% university educated) in this longitudinal substudy of the Molecular Screening and Therapeutics Program (MoST), completed questionnaires before and after receiving CGP results. MoST participants, recruited from Australian oncology clinics, undergo CTGP, and if there are actionable findings, are offered treatment in a related therapeutic trial if available. RESULTS: Patients who received actionable results, (n = 356, 64%) had lower gene-related distress (MICRA) (p < 0.001) and Impact of Events scores (p = 0.039) than patients with non-actionable results. Those with actionable results offered ensured access to tailored treatment (n = 151) reported lower anxiety (p = 0.002) and depressive symptoms (p = 0.01) and greater hope (p = 0.002) than those not offered. Positive attitudes towards uncertainty and higher self-efficacy for coping with results were associated with lower psychological distress and uncertainty, and higher hope and satisfaction with the decision to have CTGP (ps=0.001-0.047). Those with higher knowledge reported greater anxiety (p = 0.034). CONCLUSION: Receiving a non-actionable CTGP result, or an actionable result without ensured access to treatment, may cause increased distress in advanced cancer patients. Coping style was also associated with distress. PRACTICE IMPLICATIONS: Pre-testing assessment and counseling addressing attitudes toward uncertainty and self-efficacy, and post-CTGP result support for patients receiving a non-actionable result or who receive an actionable results without ensured access to treatment, may benefit patients.

Measuring female breast cancer survivors' concerns about late effects of treatment: initial development of the Concerns about Late Effects in Oncology Questionnaire (CLEO).

PURPOSE: While an increasing number of women are surviving breast cancer, survivors remain at risk of developing late effects. Late effects are long-term side effects which may emerge months to years after completing active treatment. Survivors may experience chronic worry and concern about the unpredictable and debilitating nature of late effects. This qualitative study aimed to explore the content validity of items included in the first patient-reported outcome measure (PROM) to quantify survivors' concerns about late effects: the Concerns about Late Effects in Oncology Questionnaire (CLEO). METHOD: Items included in the CLEO were informed by a literature review and consultation with expert stakeholders. Breast cancer survivors completed "think aloud" interviews to explore the perceived acceptability, relevance, clarity, and feasibility of the CLEO. Interviews were transcribed verbatim and analyzed using framework analysis. RESULTS: Twenty-eight participants were interviewed. Participants indicated the CLEO was acceptable, relevant to women's experiences of late effects, and easy to use and understand. Of the 55 proposed items, participants endorsed 33 items across six domains and suggested to include one additional item. CONCLUSIONS: These findings suggest the CLEO captured concerns relevant to breast cancer survivors and provides initial validation of items for inclusion in the CLEO. The CLEO may improve communication about late effects in clinical settings and prompt future research into evidence-based interventions for survivors. Future research should assess the relevance of the CLEO items to other cancer populations. The psychometric properties of the CLEO will be evaluated in future stages of questionnaire development.

Value of whole-genome sequencing to Australian cancer patients and their first-degree relatives participating in a genomic sequencing study.

Genomic Sequencing (GS) to identify high cancer risk will soon enter clinical practice at significant cost to the health system. This study aimed to quantify perceived value of GS to Australian cancer patients and their first-degree relatives participating in a genomic sequencing study, and factors associated with value. Participants were recruited upon consent to the genomics study. Eligible participants (with cancer of likely genetic etiology, or a first-degree relative) completed a questionnaire prior to GS. Willingness to pay was assessed via hypothetical trade-off scenarios of actionable result return rates of 1%, 10%, 20%, 30%, 40% or 50%. Of 348 probands and 213 relatives (92% and 93% response rate), 81% would consistently have GS for as little as a 1% actionable return rate. Participants would pay a median of $1,000 for return rates of at least 20% (probands) or 30% (relatives), and $300 for lower return rates. Probands with common cancers and negative attitudes to uncertainty were more likely to have GS; those with higher education were more willing to pay $1,000 and $3,000 for lower return rates. This study found high interest in, but lower willingness to pay for GS in cancer patients and their first-degree relatives, possibly due to inability to pay. Further research is needed to improve our understanding of how individuals in different risk circumstances, trade-off the risks, harms, and benefits of GS.

Cancer patient knowledge about and behavioral intentions after germline genome sequencing.

OBJECTIVES: Germline genome sequencing (GS) is becoming mainstream in cancer diagnosis and risk management. Identifying knowledge gaps and determinants of health behavior change intentions will enable effective targeting of educational and management strategies to translate genomic findings into improved cancer outcomes. METHODS: Probands diagnosed with cancer of likely genetic origin that consented to but not yet undergone GS, and their biological relatives, completed a cross-sectional questionnaire assessing GS knowledge and hypothetical intention to change behaviors. RESULTS: Probands (n = 348; 57% university educated) and relatives (n = 213; 38% university educated) had moderate GS knowledge levels, with greater knowledge associated with higher education. Both populations reported high behavioral change intentions, significantly associated with being female (p = 0.01) and greater perceived importance of GS (p < 0.001), and for probands: being from English-speaking households (p = 0.003), higher socio-economic status (p = 0.01) and greater self-efficacy (p = 0.02). CONCLUSIONS: Increasing GS knowledge will enable realistic participant expectations surrounding germline GS. Actual behavior change should be monitored to determine whether increased cancer risk knowledge results in altered cancer-related behavior and ultimately, cancer outcomes. PRACTICE IMPLICATIONS: Educational resources should target specific populations to ensure informed decision-making and expectation management. Support tools facilitating and maintaining behavioral change may be needed to achieve improved cancer patient outcomes.

Psychological predictors of advanced cancer patients' preferences for return of results from comprehensive tumor genomic profiling.

This study assessed the psychological predictors of preferences for return of comprehensive tumor genomic profiling (CTGP) results in patients with advanced cancers, enrolled in the Molecular Screening and Therapeutics Program. Patients completed a questionnaire prior to undergoing CTGP. Of the 1434 who completed a questionnaire, 96% would like to receive results that can guide treatment for their cancer, and preference for receiving this type of result was associated with lower tolerance of uncertainty. Sixty-four percent would like to receive results that cannot guide treatment, and lower tolerance of uncertainty, self-efficacy, and perceived importance were associated with this preference. Fifty-nine percent would like to receive variants of unknown significance, which was associated with lower tolerance of uncertainty, higher self-efficacy, and perceived importance. Eighty-six percent wanted to receive germline results that could inform family risk. This was associated with higher self-efficacy, perceived importance, and perceived susceptibility. Although most patients wanted to receive all types of results, given the differing patient preferences regarding the return of results depending on the utility of the different types of results, it appears critical to safeguard patient understanding of result utility to achieve informed patient choices. This should be accompanied by appropriate consent processes.