A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing.

BACKGROUND: Patients with cancer require adequate preparation in self-management of treatment toxicities to reduce morbidity that can be achieved through well-designed digital technologies that are developed in co-design with patients and end users. OBJECTIVE: We undertook a user-centered co-design process in partnership with patients and other knowledge end users to develop and iteratively test an evidence-based and theoretically informed web-based cancer self-management program (I-Can Manage). The specific study aims addressed in 2 phases were to (1) identify from the perspective of patients with cancer and clinicians the desired content, features, and functionalities for an online self-management education and support (SMES) program to enable patient self-management of treatment toxicities (phase 1); (2) develop the SMES prototype based on human-centered, health literate design principles and co-design processes; and (3) evaluate usability of the I-Can Manage prototype through user-centered testing (phase 2). METHODS: We developed the I-Can Manage program using multiperspective data sources and based on humanistic and co-design principles with end users engaged through 5 phases of development. We recruited adult patients with lung, colorectal, and lymphoma cancer receiving systemic treatments from ambulatory clinics in 2 regional cancer programs for the qualitative inquiry phase. The design of the program was informed by data from qualitative interviews and focus groups, persona and journey mapping, theoretical underpinnings of social cognitive learning theory, and formalized usability testing using a cognitive think-aloud process and user satisfaction survey. A co-design team comprising key stakeholders (human design experts, patients/caregiver, clinicians, knowledge end users, and e-learning and digital design experts) was involved in the developmental process. We used a cognitive think-aloud process to test usability and participants completed the Post-Study System Usability Questionnaire (PSSUQ). RESULTS: In the initial qualitative inquiry phase, 16 patients participated in interviews and 19 clinicians participated in interviews or focus groups and 12 key stakeholders participated in a persona journey mapping workshop to inform development of the program prototype. The I-Can Manage program integrates evidence-based information and strategies for the self-management of treatment toxicities and health-promoting behaviors in 6 e-learning modules (lay termed "chapters"), starting with an orientation to self-management. Behavioral exercises, patient written and video stories, downloadable learning resources, and online completion of goals and action plans were integrated across chapters. Patient participants (n=5) with different cancers, gender, and age worked through the program in the human factors laboratory using a cognitive think-aloud process and all key stakeholders reviewed each chapter of the program and approved revisions. Results of the PSSUQ (mean total score: 3.75) completed following the cognitive think-aloud process (n=5) suggest patient satisfaction with the usability of I-Can Manage. CONCLUSIONS: The I-Can Manage program has the potential for activating patients in self-management of cancer and treatment toxicities but requires testing in a larger randomized controlled trial.

Development of an eHealth Tool for Capturing and Analyzing the Immune-related Adverse Events (irAEs) in Cancer Treatment.

Introduction: Immunotherapy has revolutionized the treatment of many different types of cancer, but it is associated with a myriad of immune-related adverse events (irAEs). Patient-reported outcome (PRO) measures have been identified as valuable tools for continuously collecting patient-centered data and are frequently used in oncology trials. However, few studies still research an ePRO follow-up approach on patients treated with Immunotherapy, potentially reflecting a lack of support services for this population. Methods: The team co-developed a digital platform (V-Care) using ePROs to create a new follow-up pathway for cancer patients receiving immunotherapy. To operationalize the first 3 phases of the CeHRes roadmap, we employed multiple methods that were integrated throughout the development process, rather than being performed in a linear fashion. The teams employed an agile approach in a dynamic and iterative manner, engaging key stakeholders throughout the process. Results: The development of the application was categorized into 2 phases: "user interface" (UI) and "user experience" (UX) designs. In the first phase, the pages of the application were segmented into general categories, and feedback from all stakeholders was received and used to modify the application. In phase 2, mock-up pages were developed and sent to the Figma website. Moreover, the Android Package Kit (APK) of the application was installed and tested multiple times on a mobile phone to proactively detect and fix any errors. After resolving some technical issues and adjusting errors on the Android version to improve the user experience, the iOS version of the application was developed. Discussion: By incorporating the latest technological developments, V-Care has enabled cancer patients to have access to more comprehensive and personalized care, allowing them to better manage their condition and be better informed about their health decisions. These advances have also enabled healthcare professionals to be better equipped with the knowledge and tools to provide more effective and efficient care. In addition, the advances in V-Care technology have allowed patients to connect with their healthcare providers more easily, providing a platform to facilitate communication and collaboration. Although usability testing is necessary to evaluate the efficacy and user experience of the app, it can be a significant investment of time and resources. Conclusion: The V-Care platform can be used to investigate the reported symptoms experienced by cancer patients receiving Immune checkpoint inhibitors (ICIs) and to compare them with the results from clinical trials. Furthermore, the project will utilize ePRO tools to collect symptoms from patients and provide insight into whether the reported symptoms are linked to the treatment. Clinical Relevance: V-Care provides a secure, easy-to-use interface for patient-clinician communication and data exchange. Its clinical system stores and manages patient data in a secure environment, while its clinical decision support system helps clinicians make decisions that are more informed, efficient, and cost-effective. This system has the potential to improve patient safety and quality of care, while also helping to reduce healthcare costs.

Promoting Self-management and Patient Activation Through eHealth: Protocol for a Systematic Literature Review and Meta-analysis.

BACKGROUND: Major advances in different cancer treatment modalities have been made, and people are now living longer with cancer. However, patients with cancer experience a range of physical and psychological symptoms during and beyond cancer treatment. New models of care are needed to combat this rising challenge. A growing body of evidence supports the effectiveness of eHealth interventions in the delivery of supportive care to people living with the complexities of chronic health conditions. However, reviews on the effects of eHealth interventions are scarce in the field of cancer-supportive care, particularly for interventions with the aim of empowering patients to manage cancer treatment-related symptoms. For this reason, this protocol has been developed to guide a systematic review and meta-analysis to assess the effectiveness of eHealth interventions for supporting patients with cancer in managing cancer-related symptoms. OBJECTIVE: This systematic review with meta-analysis is conducted with the aim of identifying eHealth-based self-management intervention studies for adult patients with cancer and evaluating the efficacy of eHealth-based self-management tools and platforms in order to synthesize the empirical evidence on self-management and patient activation through eHealth. METHODS: A systematic review with meta-analysis and methodological critique of randomized controlled trials is conducted following Cochrane Collaboration methods. Multiple data sources are used to identify all potential research sources for inclusion in the systematic review: (1) electronic databases such as MEDLINE, (2) forward reference searching, and (3) gray literature. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for conducting the review were followed. The PICOS (Population, Interventions, Comparators, Outcomes, and Study Design) framework is used to identify relevant studies. RESULTS: The literature search yielded 10,202 publications. The title and abstract screening were completed in May 2022. Data will be summarized, and if possible, meta-analyses will be performed. It is expected to finalize this review by Winter 2023. CONCLUSIONS: The results of this systematic review will provide the latest data on leveraging eHealth interventions and offering effective and sustainable eHealth care, both of which have the potential to improve quality and efficiency in cancer-related symptoms. TRIAL REGISTRATION: PROSPERO 325582; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=325582. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38758.

Acceptability and accuracy of patient-reported outcome measures (PROMs) for surveillance of breathlessness in routine lung cancer care: A mixed-method study.

BACKGROUND: Breathlessness in lung cancer negatively impacts on quality of life but often goes undetected and undertreated in clinical practice. There is a need for routine surveillance for early identification and proactive management of breathlessness using patient reported outcome measures (PROMs) in clinical care but it is unclear what PROMs should be used or are accurate for use in routine care. METHODS: We used mixed-methods (quantitative surveys and qualitative interviews) to examine the predictors of breathlessness in 339 lung cancer participants and acceptability of PROMs. In addition to multivariate analysis to examine predictors of dyspnea, participants completed an acceptability survey and themes were derived for the qualitative data (n = 26) to explore patient experience of PROMs. We also tested the accuracy of PROMs using a Receiver Operating Characteristic and Area Under the Curve analysis. RESULTS: A total of 339 patients completed the breathlessness PROMs and acceptability survey and 26 patients participated in an in-depth interview to investigate their experiences of breathlessness and its PROMs. Prevalence of breathlessness was 51.9 % (n = 176) and 70.5 % of patients preferred the Medical Research Council (MRC) scale followed by the Breathlessness Intensity (BI) scale (63.7 %) among the five measures for breathlessness- Modified Borg Scale (MBS), Cancer Dyspnea Scale (CDS), MRC, BI, and Breathlessness Distress (BD). The finding showed wide variation in the MRC grades across the BI rating even among patients with the same BI score. AUC scores for the Borg scale was 0.71 (using MRC cut-off score of < 2), for CDS, 0.72, for BD, 0.70, and for BI 0.79. For an MRC score of 2, the Borg score cut-off was 0.8 (optimal sensitivity, 50 %; specificity, 93.3 %); the cut-off score of CDS, BD, BI score was 1.4 (optimal sensitivity, 67.1 %; specificity, 70 %), 1.5 (optimal sensitivity, 57.5 %; specificity, 73.3 %), and 1.5 (optimal sensitivity, 72.6 %; specificity, 83.3 %) respectively. AUC by ROC analysis for breathlessness and modest concordance among five PROMs showed important gaps between the individuals' experience and PROMs data. Three main themes from qualitative data included 1) Making sense of symptom reporting, 2) Valuing the reported data, 3) Managing the symptom of breathlessness. CONCLUSION: This study examined measurement of breathlessness using PROMs for routine clinical care and showed that severity measures alone do not accurately detect this symptomnor the experiential dimensions of breathlessness that are critical to guide appropriate intervention.

Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol.

INTRODUCTION: Technology is emerging as a solution to develop home-based, proactive 'real-time' symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities. METHODS AND ANALYSIS: This study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS-Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians. ETHICS AND DISSEMINATION: The study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03335189.

Implementation of self-management support in cancer care and normalization into routine practice: a systematic scoping literature review protocol.

BACKGROUND: Cancer survivors face a myriad of biopsychosocial consequences due to cancer and treatment that may be potentially mitigated through enabling their self-management skills and behaviors for managing illness. Unfortunately, the cancer system lags in its systematic provision of self-management support (SMS) in routine care, and it is unclear what implementation approaches or strategies work to embed SMS in the cancer context to inform health policy and administrator decision-making. METHODS/DESIGN: A comprehensive scoping review study of the literature will be conducted based on methods and steps identified by Arksey and O'Malley and experts in the field. Electronic searches will be conducted in multiple databases including CINAHL, CENTRAL, EMBASE, PsycINFO, MEDLINE, AMED, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE) (up to Issue 2, 2015), ISI Proceedings (Web of Science), PsychAbstracts, and Sociological Abstracts from January 1997 to November 5, 2018. Following the PRISMA-Extension for Scoping Reviews (PRISMA-ScR), two authors will independently screen all titles/abstracts to determine eligibility, data will be abstracted by one author and checked by a second author, and findings will be narratively summarized based on constructs of implementation in the Normalization Process Theory. DISCUSSION: This will be the first scoping review study to synthesize knowledge of implementation of SMS in the cancer care context and the implementation approaches and strategies on embedding in care. This information will be critical to inform health policy and knowledge end users about the necessary changes in care to embed SMS in practices and to stimulate future research.

Usability Evaluation of a Mobile Phone-Based System for Remote Monitoring and Management of Chemotherapy-Related Side Effects in Cancer Patients: Mixed-Methods Study.

BACKGROUND: As most chemotherapy is administered in the outpatient setting, patients are required to manage related side effects at home without direct support from health professionals. The Advanced Symptom Management System (ASyMS) has been developed to facilitate the remote monitoring and management of chemotherapy-related toxicity in patients with cancer, using patient-reported outcomes questionnaires and a clinician alerting system. OBJECTIVE: This study aims to evaluate the usability of the ASyMS, a mobile phone-based technology, from the perspective of Canadian patients with cancer receiving chemotherapy to identify existing design, functionality, and usability issues and elicit their views, experiences, and satisfaction with the ASyMS. METHODS: We used a mixed-method approach to data collection with user-based testing, a think-aloud technique, semistructured interviews, and short answer questionnaires with a purposive sample of 10 patients with cancer. Participants attended usability testing sessions at the Centre for Global eHealth Innovation, University Health Network, and performed specific tasks on the ASyMS device. The test was videorecorded and each task was timed during the test. After the usability sessions, participants completed a posttest questionnaire and participated in a semistructured qualitative interview. A thematic analysis was used to code and categorize the identified issues into themes that summarized the type and frequency of occurrence. RESULTS: The thematic analysis generated 3 overarching themes as follows: ASyMS user-friendliness; usefulness of ASyMS (content quality and richness); and intention to use. Results from the posttest questionnaire indicated that 80% (8/10) of participants had great motivation to use the ASyMS, 70% (7/10) had positive perceptions of the successful use of the ASyMS, and all (10/10, 100%) had a positive attitude toward using the ASyMS in the future. Most identified design and functionality issues were related to the navigation of the ASyMS device and a desire for a more attractive design with advanced functionality and features. The main general design recommendations were as follows: enhance the readability of the screen; implement advance options (eg, search option); and support better navigation. CONCLUSIONS: The ASyMS has shown positive perceptions of patients in usability testing and qualitative interviews. An evaluation of the effects of the ASyMS on symptom outcomes in a clinical trial is needed.

Prevention and management of chemotherapy-induced nausea and vomiting.

Nausea and vomiting are among the most frequently experienced toxic side-effects associated with chemotherapy. Although nausea and vomiting can result from surgery or radiotherapy, chemotherapy-induced nausea and vomiting (CINV) is potentially the most severe and most distressing. Estimates regarding the incidence of CINV vary depending on the treatment administered and individual patient characteristics.The impact of CINV on quality of life (QoL) and daily activities is considerable. Pharmacological treatments are considered routine for CINV. Clinical guidelines now recommend that patients receiving moderate emetic chemotherapy (MEC) regimens be preferentially treated with palonosetron, the 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, in combination with dexamethasone. In addition, it has shown that single-dose fosaprepitant is equivalent to the standard 3-day aprepitant regimen (the neurokinin 1 (NK1) receptor antagonist). Despite these advances in antiemetic management, approximately 50% of patients receiving chemotherapy still experience nausea and/or vomiting. Further improvements are still desirable, particularly in the prevention and treatment of delayed CINV. Non-pharmacological interventions can be possible adjuncts to standard anti-emetic therapy. Using new technologies to collect patient-reported outcomes may improve the accuracy of assessment, provide a better picture of the patient's experience of these symptoms, and provide a means to simultaneously monitor symptoms, educate patients, and collect longitudinal data.

Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design.

PURPOSE: Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness of Nevasic to control CINV. METHODS: A mixed methods design incorporating an RCT and focus group interviews. For the RCT, female breast cancer patients were randomized to receive either Nevasic plus usual care, music plus usual care, or usual care only. Data were analysed using descriptive statistics and linear mixed-effects models. Five focus group interviews were conducted to obtain participants' views regarding the acceptability of the interventions in the trial. RESULTS: 99 participants were recruited to the RCT and 15 participated in focus group interviews. Recruitment targets were achieved. Issues of Nevasic acceptability were highlighted as weaknesses of the program. This study did not detect any evidence for the effectiveness of Nevasic; however, the results showed statistically significant less use of anti-emetics (p = 0.003) and borderline non-significant improvement in quality of life (p = 0.06). CONCLUSIONS: Conducting a non-pharmacological intervention using such an audio program is feasible, although difficulties and limitations exist with its use. Further studies are required to investigate the effectiveness of Nevasic from perspectives such as anti-emetic use, as well as its overall effect on the levels of nausea and vomiting.

Efficacy of extracorporeal shockwave therapy in frozen shoulder.

BACKGROUND: Frozen shoulder has always been considered important because of the impact on the quality-of-life and long period of illness. Therefore, the use of noninvasive and safe techniques that can speed up the healing process of the disease is important. METHODS: This study was a randomized clinical trial study on patients suffering from frozen shoulder who were referred to Isfahan University of Medical Sciences hospitals in 2011 and 2012. A total of 36 patients were enrolled in the study. Eligible patients were allocated into two groups. Intervention group received extracorporeal shockwave therapy (ESWT) once a week for 4 weeks. The control group received sham shockwave therapy once a week for 4 weeks. On the follow-up period, changes in individual performance and the amount of pain and disability were assessed by the Shoulder Pain and Disability Index (SPADI) questionnaire and the range of motion changes were assessed by a goniometer. Data obtained were analyzed using SPSS software. RESULTS: Variance analysis revealed a difference in the mean pain and disability score of the SPADI questionnaire, flexion, extension, and abduction, external rotation of involved shoulder between two groups before and after the shockwave therapy (P < 0.05). Improvement was more satisfactory in the intervention group, but the mean internal rotation did not differ significantly in two groups (P > 0.05). CONCLUSIONS: The use of ESWT seems to have positive effects on treatment, quicker return to daily activities, and quality-of-life improvement on frozen shoulder.