Digital Remote Monitoring Using an mHealth Solution for Survivors of Cancer: Protocol for a Pilot Observational Study.

BACKGROUND: Healthy lifestyle interventions have a positive impact on multiple disease trajectories, including cancer-related outcomes. Specifically, appropriate habitual physical activity, adequate sleep, and a regular wholesome diet are of paramount importance for the wellness and supportive care of survivors of cancer. Mobile health (mHealth) apps have the potential to support novel tailored lifestyle interventions. OBJECTIVE: This observational pilot study aims to assess the feasibility of mHealth multidimensional longitudinal monitoring in survivors of cancer. The primary objective is to test the compliance (user engagement) with the monitoring solution. Secondary objectives include recording clinically relevant subjective and objective measures collected through the digital solution. METHODS: This is a monocentric pilot study taking place in Bangor, Wales, United Kingdom. We plan to enroll up to 100 adult survivors of cancer not receiving toxic anticancer treatment, who will provide self-reported behavioral data recorded via a dedicated app and validated questionnaires and objective data automatically collected by a paired smartwatch over 16 weeks. The participants will continue with their normal routine surveillance care for their cancer. The primary end point is feasibility (eg, mHealth monitoring acceptability). Composite secondary end points include clinically relevant patient-reported outcome measures (eg, the Edmonton Symptom Assessment System score) and objective physiological measures (eg, step counts). This trial received a favorable ethical review in May 2023 (Integrated Research Application System 301068). RESULTS: This study is part of an array of pilots within a European Union funded project, entitled "GATEKEEPER," conducted at different sites across Europe and covering various chronic diseases. Study accrual is anticipated to commence in January 2024 and continue until June 2024. It is hypothesized that mHealth monitoring will be feasible in survivors of cancer; specifically, at least 50% (50/100) of the participants will engage with the app at least once a week in 8 of the 16 study weeks. CONCLUSIONS: In a population with potentially complex clinical needs, this pilot study will test the feasibility of multidimensional remote monitoring of patient-reported outcomes and physiological parameters. Satisfactory compliance with the use of the app and smartwatch, whether confirmed or infirmed through this study, will be propaedeutic to the development of innovative mHealth interventions in survivors of cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52957.

Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up.

AIMS: Somatic genetic testing in non-squamous, non-small cell lung carcinoma (NSCLC) patients is required to highlight subgroups eligible for a number of novel oncological therapies. This study aims to determine whether turnaround times for reporting epidermal growth factor receptors (EGFR) by next-generation sequencing (NGS) alone is sufficient to meet the needs of lung cancer patients. METHODS: We performed a retrospective case series with follow-up. Outcomes of EGFR testing (102 tests) in 96 patients by NGS were compared with a rapid, fully automated PCR-based platform (Idylla) in local histopathology laboratories. RESULTS: Turnaround time for reporting NGS was 17 calendar days. Reporting using the Idylla EGFR Mutation Test, by contrast, gave a potential turnaround time of 3.8 days from request to authorisation. Three-quarters of patients presenting with stage IV disease had a performance status of 0, 1, or 2 but 18% experienced rapid clinical deterioration (p<0.05). A third of these patients were deceased by the time NGS reports were available. CONCLUSIONS: We discuss issues around integrating rapid PCR testing alongside NGS in multidisciplinary care pathways and strategies for mitigating against foreseeable difficulties. Dual testing for stage IV non-squamous, NSCLC patients has the potential to improve care and survival outcomes by providing access to the right test at the right time.

Evaluating process and effectiveness of a low-intensity CBT intervention for women with gynaecological cancer (the EPELIT Trial).

Background: Improving survival from gynaecological cancers is creating an increasing clinical challenge for long-term distress management. Psychologist-led interventions for cancer survivors can be beneficial, but are often costly. The rise of the Psychological Wellbeing Practitioner (PWP) workforce in the UK might offer a cheaper, but equally effective, intervention delivery method that is more sustainable and accessible. We aimed to test the effectiveness of a PWP co-facilitated intervention for reducing depression and anxiety, quality of life and unmet needs. Methods: We planned this trial using a pragmatic, non-randomised controlled design, recruiting a comparator sample from a second clinical site. The intervention was delivered over six-weekly sessions; data were collected from participants at baseline, weekly during the intervention, and at one-week and three-month follow-up. Logistical challenges meant that we only recruited 8 participants to the intervention group, and 26 participants to the control group. Results: We did not find significant, between-group differences for depression, quality of life or unmet needs, though some differences at follow-up were found for anxiety ( p<.001). Analysis of potential intervention mediator processes indicated the potential importance of self-management self-efficacy. Low uptake into the psychological intervention raises questions about (a) patient-driven needs for group-based support, and (b) the sustainability of this intervention programme. Conclusions: This study failed to recruit to target; the under-powered analysis likely explains the lack of significant effects reported, though some trends in the data are of interest. Retention in the intervention group, and low attrition in the control group indicate acceptability of the intervention content and trial design; however a small baseline population rendered this trial infeasible in its current design. Further work is required to answer our research questions, but also, importantly, to address low uptake for psychological interventions in this group of cancer survivors. Trial registration: ClinicalTrials.gov, NCT03553784 (registered 14 June 2018).

An increasing number of people are surviving for longer time periods following treatment for gynaecological cancer and this means we need to change how we care for and support a growing cancer survivor population. Psychological distress and poor quality of life are common in people affected by cancer, and these do not always improve once treatment ends. Providing psychological support can be expensive, which means that not everyone who wants it can access it. Psychological Wellbeing Practitioners (PWPs) have been introduced in UK health care. This workforce might offer an alternative for providing psychological support to a greater number of cancer survivors. We aimed to test how good a PWP co-delivered intervention is at improving depression, anxiety and quality of life in people who had been treated for gynaecological cancer. The intervention was delivered to small groups of patients over six weekly sessions. We compared those who received the intervention with a similar patient group who did not have access to the same psychological support from a different hospital. Participants reported their psychological wellbeing and quality of life at the point of recruitment, weekly for six weeks, and then at follow-up time-points one week and three months later. Because of low interest in the group intervention we did not recruit to target. Only 8 participants took part in the intervention, and we recruited only 26 participants in the control group. This means we can't have full confidence in our results. Nonetheless, the findings indicate that this intervention was helpful for improving participants' anxiety levels. Further trials, which recruit a larger number of cancer survivors, are needed to answer our research questions. However, this trial indicates acceptability and potential benefit. We also need to undertake research to understand why so few cancer survivors wanted to take part in this group-based intervention.

Correction: Checklists for Complications During Systemic Cancer Treatment Shared by Patients, Friends, and Health Care Professionals: Prospective Interventional Cohort Study.

[This corrects the article DOI: 10.2196/19225.].

Checklists for Complications During Systemic Cancer Treatment Shared by Patients, Friends, and Health Care Professionals: Prospective Interventional Cohort Study.

BACKGROUND: Advances in cancer management have been associated with an increased incidence of emergency presentations with disease- or treatment-related complications. OBJECTIVE: This study aimed to measure the ability of patients and members of their social network to complete checklists for complications of systemic treatment for cancer and examine the impact on patient-centered and health-economic outcomes. METHODS: A prospective interventional cohort study was performed to assess the impact of a smartphone app used by patients undergoing systemic cancer therapy and members of their network to monitor for common complications. The app was used by patients, a nominated "safety buddy," and acute oncology services. The control group was made up of patients from the same institution. Measures were based on process (completion of checklists over 60 days), patient experience outcomes (Hospital Anxiety and Depression Scale and the General version of the Functional Assessment of Cancer Therapy at baseline, 1 month, and 2 months) and health-economic outcomes (usage of appointments in primary care and elective and unscheduled hospital admissions). RESULTS: At the conclusion of the study, 50 patients had completed 2882 checklists, and their 50 "safety buddies" had completed 318 checklists. Near daily usage was maintained over the 60-day study period. When compared to a cohort of 50 patients with matching disease profiles from the same institution, patients in the intervention group had comparable changes in Hospital Anxiety and Depression Scale and General version of the Functional Assessment of Cancer Therapy. Patients in the Intervention Group required a third (32 vs 97 nights) of the hospital days with overnight stay compared to patients in the Control Group, though the difference was not significant. The question, "I feel safer with the checklist," received a mean score of 4.27 (SD 0.87) on a Likert scale (1-5) for patients and 4.55 (SD 0.65) for family and friends. CONCLUSIONS: Patients undergoing treatment for cancer and their close contacts can complete checklists for common complications of systemic treatments and take an active role in systems supporting their own safety. A larger sample size will be needed to assess the impact on clinical outcomes and health economics.

Erlotinib and gefitinib for treating non-small cell lung cancer that has progressed following prior chemotherapy (review of NICE technology appraisals 162 and 175): a systematic review and economic evaluation.

BACKGROUND: Lung cancer is the second most diagnosed cancer in the UK. Over 70% of lung cancers are non-small cell lung cancers (NSCLCs). Patients with stage III or IV NSCLC may be offered treatment to improve survival, disease control and quality of life. One-third of these patients receive further treatment following disease progression; these treatments are the focus of this systematic review. OBJECTIVES: To appraise the clinical effectiveness and cost-effectiveness of erlotinib [Tarceva(®), Roche (UK) Ltd] and gefitinib (IRESSA(®), AstraZeneca) compared with each other, docetaxel or best supportive care (BSC) for the treatment of NSCLC after disease progression following prior chemotherapy. The effectiveness of treatment with gefitinib was considered only for patients with epidermal growth factor mutation-positive (EGFR M+) disease. DATA SOURCES: Four electronic databases (EMBASE, MEDLINE, The Cochrane Library, PubMed) were searched for randomised controlled trials (RCTs) and economic evaluations. Manufacturers' evidence submissions to the National Institute for Health and Care Excellence were also considered. REVIEW METHODS: Outcomes for three distinct patient groups based on EGFR mutation status [EGFR M+, epidermal growth factor mutation negative (EGFR M-) and epidermal growth factor mutation status unknown (EGFR unknown)] were considered. Heterogeneity of the data precluded statistical analysis. A de novo economic model was developed to compare treatments (incremental cost per quality-adjusted life-year gained). RESULTS: Twelve trials were included in the review. The use of gefitinib was compared with chemotherapy (n = 6) or BSC (n = 1), and the use of erlotinib was compared with chemotherapy (n = 3) or BSC (n = 1). One trial compared the use of gefitinib with the use of erlotinib. No trials included solely EGFR M+ patients; all data were derived from retrospective subgroup analyses from six RCTs [Kim ST, Uhm JE, Lee J, Sun JM, Sohn I, Kim SW, et al. Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy. Lung Cancer 2012;75:82-8, V-15-32, Tarceva In Treatment of Advanced NSCLC (TITAN), BR.21, IRESSA Survival Evaluation in Lung cancer (ISEL) and IRESSA NSCLC Trial Evaluating REsponse and Survival versus Taxotere (INTEREST)]. These limited data precluded conclusions regarding the clinical effectiveness of any treatment for EGFR M+ patients. For EGFR M- patients, data were derived from the TArceva Italian Lung Optimization tRial (TAILOR) trial and Docetaxel and Erlotinib Lung Cancer Trial (DELTA). Retrospective data were also derived from subgroup analyses of BR.21, Kim et al., TITAN, INTEREST and ISEL. The only statistically significant reported results were for progression-free survival (PFS) for TAILOR and DELTA, and favoured docetaxel over erlotinib [TAILOR hazard ratio (HR) 1.39, 95% confidence interval (CI) 1.06 to 1.82; DELTA HR 1.44, 95% CI 1.08 to 1.92]. In EGFR unknown patients, nine trials (INTEREST, IRESSA as Second-line Therapy in Advanced NSCLC - KoreA, Li, Second-line Indication of Gefitinib in NSCLC, V-15-32, ISEL, DELTA, TITAN and BR.21) reported overall survival data and only one (BR.21) reported a statistically significant result favouring the use of erlotinib over BSC (HR 0.7, 95% CI 0.58 to 0.85). For PFS, BR.21 favoured the use of erlotinib when compared with BSC (HR 0.61, 95% CI 0.51 to 0.74) and the use of gefitinib was favoured when compared with BSC (HR 0.82, 95% CI 0.73 to 0.92) in ISEL. Limitations in the clinical data precluded assessment of cost-effectiveness of treatments for an EGFR M+ population by the Assessment Group (AG). The AG's economic model suggested that for the EGFR M- population, the use of erlotinib was not cost-effective compared with the use of docetaxel and compared with BSC. For EGFR unknown patients, the use of erlotinib was not cost-effective when compared with BSC. CONCLUSIONS/FUTURE WORK: The lack of clinical data available for distinct patient populations limited the conclusions of the assessment. Future trials should distinguish between patients with EGFR M+ and EGFR M- disease. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Intractable malignant ascites: an alternative management option.

BACKGROUND: Recurrent malignant ascites is a common management problem in oncology and palliative care. DISCUSSION: Here, we describe a case of malignant ascites managed by insertion of a Tenckhoff Catheter (TC), which resulted in successful symptomatic control and improvement in quality of life.