The trials and tribulations of conducting an m-health pilot randomized controlled trial to improve oral cancer therapy adherence: recommendations for future multisite, non-drug clinical trials

Abstract Objective Integrating mobile phone-based health (m-health) interventions into healthcare systems is one solution to improve access to services for the growing number of patients with chronic illness. Practical challenges such as poor recruitment and inadequate resource allocation can hamper the assessment of such interventions with clinical trial methodology. This paper highlights the challenges encountered during a pilot randomized controlled trial of an m-health medication adherence intervention and offers recommendations for future multi-site, non-drug clinical trials. Results Eighteen patients were recruited to the study; eight were randomly allocated to the intervention arm. Intervention participants responded to their daily medication-reminder text messages, indicating that medication had been taken or not, and nurses were able to organize their calls around their workload. The trial closed prematurely primarily due to inadequate numbers of eligible patients; however, other potentially resolvable feasibility issues were identified. These included lack of infrastructure at study sites, poor screening data acquisition and management processes, and inexperience in conducting supportive care trials at participating sites. M-health intervention trials are designed to inform implementation of best supportive care practice. Adequate skills and infrastructure are research prerequisites that require careful consideration and sufficient investment for the successful execution of multi-site supportive care trials. Trial registration Australian and New Zealand Clinical Trials Register: ACTRN1261200063586

Exploring knowledge, attitudes, and practice associated with meditation among patients with melanoma

Aim: To explore the knowledge, attitudes, and practices associated with meditation among people with melanoma and investigate the relationship between perceived stress, trait mindfulness, and meditation. Factors associated with interest to participate in an online meditation program were also explored. Methods: A survey-based cross-sectional study of 291 patients attending a melanoma outpatient clinic assessed knowledge of meditation, attitudes toward meditation using Determinants of Meditation Practice Inventory (DMPI), and meditation experience. Perceived stress and trait mindfulness were measured using the Perceived Stressed Scale and Cognitive and Affective Mindfulness Scale, respectively. Results: Participants who had tried meditation (43%) were likely to be younger, female, and have completed higher education or be employed. Perceived stress score was higher among women, younger participants, and those treated in the past year but did not differ by melanoma stage. Participants reported a good understanding of the potential benefits of meditation, but even among people with meditation experience, common misconceptions prevailed. The main barrier to meditation was a perceived lack of knowledge about meditation . Higher DMPI scores were associated with lower education, moderate to low access to service centers, or living in disadvantaged neighborhoods . Participants practicing meditation that involved self-reflection reported less stress and higher trait mindfulness compared with participants practicing another type of meditation. People interested in participating in an online meditation-based program reported higher perceived stress than those not interested. Conclusion: A meditation-based intervention teaching self-reflective practices, targeted at people with melanoma, may have the potential to assist them with managing their stress

The implications of ambitious decarbonisation of heat and road transport for Britain's net zero carbon energy systems

Decarbonisation of heating and road transport are regarded as necessary but very challenging steps on the pathway to net zero carbon emissions. Assessing the most efficient routes to decarbonise these sectors requires an integrated view of energy and road transport systems. Here we describe how a national gas and electricity transmission network model was extended to represent multiple local energy systems and coupled with a national energy demand and road transport model. The integrated models were applied to assess a range of technologies and policies for heating and transport where the UK’s 2050 net zero carbon emissions target is met. Overall, annual primary energy use is projected to reduce by between 25% and 50% by 2050 compared to 2015, due to ambitious efficiency improvements within homes and vehicles. However, both annual and peak electricity demands in 2050 are more than double compared with 2015. Managed electric vehicle charging could save 14TWh/year in gas-fired power generation at peak times, and associated emissions, whilst vehicle-to-grid services could provide 10GW of electricity supply during peak hours. Together, managed vehicle charging, and vehicle-to-grid supplies could result in a 16% reduction in total annual energy costs. The provision of fast public charging facilities could reduce peak electricity demand by 17GW and save an estimated £650 million annually. Although using hydrogen for heating and transport spreads the hydrogen network costs between homeowners and motorists, it is still estimated to be more costly overall compared to an all-electric scenario. Bio-energy electricity generation plants with carbon capture and storage are required to drive overall energy system emissions to net zero, utilisation of which is lowest when heating is electrified, and road transport consists of a mix of electric and hydrogen fuel-cell vehicles. The analysis demonstrates the need for an integrated systems approach to energy and transport policies and for coordination between national and local governments

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial

BackgroundPeople with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial.Methods/designThis is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5–10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments.DiscussionThis feasibility study will evaluate participants’ satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing

Mobile health intervention to increase oral cancer therapy adherence in patients with chronic myeloid leukemia (the REMIND system): clinical feasibility and acceptability assessment

Background: Optimal dosing of oral tyrosine kinase inhibitor therapy is critical to treatment success and survival of patients with chronic myeloid leukemia (CML). Drug intolerance secondary to toxicities and nonadherence are significant factors in treatment failure.Objective: The objective of this study was to develop and pilot-test the clinical feasibility and acceptability of a mobile health system (REMIND) to increase oral drug adherence and patient symptom self-management among people with CML (chronic phase).Methods: A multifaceted intervention was iteratively developed using the intervention development framework by Schofield and Chambers, consisting of defining the patient problem and iteratively refining the intervention. The clinical feasibility and acceptability were examined via patient and intervention nurse interviews, which were audiotaped, transcribed, and deductively content analyzed.Results: The intervention comprised 2 synergistically operating elements: (1) daily medication reminders and routine assessment of side effects with evidence-based self-care advice delivered in real time and (2) question prompt list (QPL) questions and routinely collected individual patient adherence and side effect profile data used to shape nurses’ consultations, which employed motivational interviewing to support adoption of self-management behaviors. A total of 4 consultations and daily alerts and advice were delivered over 10 weeks. In total, 58% (10/17) of patients and 2 nurses participated in the pilot study. Patients reported several benefits of the intervention: help in establishing medication routines, resolution of symptom uncertainty, increased awareness of self-care, and informed decision making. Nurses also endorsed the intervention: it assisted in establishing pill-taking routines and patients developing effective solutions to adherence challenges.Conclusions: The REMIND system with nurse support was usable and acceptable to both patients and nurses. It has the potential to improve adherence and side-effect management and should be further evaluated

What is the prevalence of fear of cancer recurrence in cancer survivors and patients? A systematic review and individual participant data meta-analysis

This study was supported by the Dutch Cancer Society (KWF) grant number 10936.Objective Care for fear of cancer recurrence (FCR) is considered the most common unmet need among cancer survivors. Yet the prevalence of FCR and predisposing factors remain inconclusive. To support targeted care, we provide a comprehensive overview of the prevalence and severity of FCR among cancer survivors and patients, as measured using the short form of the validated Fear of Cancer Recurrence Inventory (FCRI-SF). We also report on associations between FCR and clinical and demographic characteristics. Methods This is a systematic review and individual participant data (IPD) meta-analysis on the prevalence of FCR. In the review, we included all studies that used the FCRI-SF with adult (≥18 years) cancer survivors and patients. Date of search: 7 February 2020. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool. Results IPD were requested from 87 unique studies and provided for 46 studies comprising 11,226 participants from 13 countries. 9311 respondents were included for the main analyses. On the FCRI-SF (range 0–36), 58.8% of respondents scored ≥13, 45.1% scored ≥16 and 19.2% scored ≥22. FCR decreased with age and women reported more FCR than men. FCR was found across cancer types and continents and for all time periods since cancer diagnosis. Conclusions FCR affects a considerable number of cancer survivors and patients. It is therefore important that healthcare providers discuss this issue with their patients and provide treatment when needed. Further research is needed to investigate how best to prevent and treat FCR and to identify other factors associated with FCR. The protocol was prospectively registered (PROSPERO CRD42020142185).Publisher PDFPeer reviewe

Delivering an online mindfulness-based program for people diagnosed with melanoma

This research provides preliminary evidence for the use of mindfulness approaches to manage cancer-related fears among people at high risk of melanoma recurrence. Findings suggests that a self-guided online mindfulness program may help people adapt to the emotional difficulties of their cancer diagnosis and treatment

Digital characteristics and dissemination indicators to optimize delivery of internet-supported mindfulness-based interventions for people with a chronic condition: systematic review

BACKGROUND: Internet-supported mindfulness-based interventions (MBIs) are increasingly being used to support people with a chronic condition. Characteristics of MBIs vary greatly in their mode of delivery, communication patterns, level of facilitator involvement, intervention period, and resource intensity, making it difficult to compare how individual digital features may optimize intervention adherence and outcomes. OBJECTIVE: The aims of this review were to (1) provide a description of digital characteristics of internet-supported MBIs and examine how these relate to evidence for efficacy and adherence to the intervention and (2) gain insights into the type of information available to inform translation of internet-supported MBIs to applied settings. METHODS: MEDLINE Complete, PsycINFO, and CINAHL databases were searched for studies assessing an MBI delivered or accessed via the internet and engaging participants in daily mindfulness-based activities such as mindfulness meditations and informal mindfulness practices. Only studies using a comparison group of alternative interventions (active compactor), usual care, or wait-list were included. Given the broad definition of chronic conditions, specific conditions were not included in the original search to maximize results. The search resulted in 958 articles, from which 11 articles describing 10 interventions met the inclusion criteria. RESULTS: Internet-supported MBIs were more effective than usual care or wait-list groups, and self-guided interventions were as effective as facilitator-guided interventions. Findings were informed mainly by female participants. Adherence to interventions was inconsistently defined and prevented robust comparison between studies. Reporting of factors associated with intervention dissemination, such as population representativeness, program adoption and maintenance, and costs, was rare. CONCLUSIONS: More comprehensive descriptions of digital characteristics need to be reported to further our understanding of features that may influence engagement and behavior change and to improve the reproducibility of MBIs. Gender differences in determinants and patterns of health behavior should be taken into account at the intervention design stage to accommodate male and female preferences. Future research could compare MBIs with established evidence-based therapies to identify the population groups that would benefit most from internet-supported programs.&nbsp