Variable selection for individualised treatment rules with discrete outcomes.

An individualised treatment rule (ITR) is a decision rule that aims to improve individuals' health outcomes by recommending treatments according to subject-specific information. In observational studies, collected data may contain many variables that are irrelevant to treatment decisions. Including all variables in an ITR could yield low efficiency and a complicated treatment rule that is difficult to implement. Thus, selecting variables to improve the treatment rule is crucial. We propose a doubly robust variable selection method for ITRs, and show that it compares favourably with competing approaches. We illustrate the proposed method on data from an adaptive, web-based stress management tool.

Barriers and enablers to the implementation of patient-reported outcome and experience measures (PROMs/PREMs): protocol for an umbrella review.

BACKGROUND: Patient-reported outcome and experience measures (PROMs and PREMs, respectively) are evidence-based, standardized questionnaires that can be used to capture patients' perspectives of their health and health care. While substantial investments have been made in the implementation of PROMs and PREMs, their use remains fragmented and limited in many settings. Analysis of multi-level barriers and enablers to the implementation of PROMs and PREMs has been hampered by the lack of use of state-of-the-art implementation science frameworks. This umbrella review aims to consolidate available evidence from existing quantitative, qualitative, and mixed-methods systematic and scoping reviews covering factors that influence the implementation of PROMs and PREMs in healthcare settings. METHODS: An umbrella review of systematic and scoping reviews will be conducted following the guidelines of the Joanna Briggs Institute (JBI). Qualitative, quantitative, and mixed methods reviews of studies focusing on the implementation of PROMs and/or PREMs in all healthcare settings will be considered for inclusion. Eight bibliographical databases will be searched. All review steps will be conducted by two reviewers independently. Included reviews will be appraised and data will be extracted in four steps: (1) assessing the methodological quality of reviews using the JBI Critical Appraisal Checklist; (2) extracting data from included reviews; (3) theory-based coding of barriers and enablers using the Consolidated Framework for Implementation Research (CFIR) 2.0; and (4) identifying the barriers and enablers best supported by reviews using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. Findings will be presented in diagrammatic and tabular forms in a manner that aligns with the objective and scope of this umbrella review, along with a narrative summary. DISCUSSION: This umbrella review of quantitative, qualitative, and mixed-methods systematic and scoping reviews will inform policymakers, researchers, managers, and clinicians regarding which factors hamper or enable the adoption and sustained use of PROMs and PREMs in healthcare settings, and the level of confidence in the evidence supporting these factors. Findings will orient the selection and adaptation of implementation strategies tailored to the factors identified. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023421845.

Self-care interventions to assist family physicians with mental health care of older patients during the COVID-19 pandemic: Feasibility, acceptability, and outcomes of a pilot randomized controlled trial.

BACKGROUND: The COVID-19 pandemic has required family physicians to rapidly address increasing mental health problems with limited resources. Vulnerable home-based seniors with chronic physical conditions and commonly undermanaged symptoms of anxiety and depression were recruited in this pilot study to compare two brief self-care intervention strategies for the management of symptoms of depression and/or anxiety. METHODS: We conducted a pilot RCT to compare two tele-health strategies to address mental health symptoms either with 1) validated CBT self-care tools plus up to three telephone calls from a trained lay coach vs. 2) the CBT self-guided tools alone. The interventions were abbreviated from those previously trialed by our team, to enable their completion in 2 months. Objectives were to assess the feasibility of delivering the interventions during a pandemic (recruitment and retention); and assess the comparative acceptability of the interventions across the two groups (satisfaction and tool use); and estimate preliminary comparative effectiveness of the interventions on severity of depression and anxiety symptoms. Because we were interested in whether the interventions were acceptable to a wide range of older adults, no mental health screening for eligibility was performed. RESULTS: 90 eligible patients were randomized. 93% of study completers consulted the self-care tools and 84% of those in the coached arm received at least some coaching support. Satisfaction scores were high among participants in both groups. No difference in depression and anxiety outcomes between the coached and non-coached participants was observed, but coaching was found to have a significant effect on participants' use and perceived helpfulness of the tools. CONCLUSION: Both interventions were feasible and acceptable to patients. Trained lay coaching increased patients' engagement with the tools. Self-care tools offer a low cost and acceptable remote activity that can be targeted to those with immediate needs. While effectiveness results were inconclusive, this may be due to the lack of eligibility screening for mental health symptoms, abbreviated toolkit, and fewer coaching sessions than those used in our previous effective interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0460937.

It's time to address fear of cancer recurrence in family caregivers: usability study of an virtual version of the Family Caregiver-Fear Of Recurrence Therapy (FC-FORT).

Background: Family caregivers of cancer survivors experience equal or greater levels of fear of cancer recurrence (FCR) than survivors themselves. Some interventions have demonstrated their ability to reduce FCR among cancer survivors and dyads (patient and caregivers). However, to date, no validated intervention exists to focus solely on family caregiver's FCR. Objectives: This study aimed to (1) adapt the evidence-based in-person Fear Of Recurrence Therapy (FORT) for family caregivers (referred here in as FC-FORT) and to a virtual delivery format and (2) test its usability when offered virtually. Methods: The adaptation of FC-FORT was overseen by an advisory board and guided by the Information Systems Research Framework. Following this adaptation, female family caregivers and therapists were recruited for the usability study. Participants took part in 7 weekly virtual group therapy sessions, a semi-structured exit interview and completed session feedback questionnaires. Therapists were offered a virtual training and weekly supervision. Fidelity of treatment administration was assessed each session. Quantitative data were analyzed using descriptive statistics. Exit interviews were transcribed verbatim using NVivo Transcription and coded using conventional content analysis. Results were presented back to the advisory board to further refine FC-FORT. Results: The advisory board (n = 16) met virtually on 7 occasions to adapt FC-FORT (i.e., patient manuals, virtual format) and discuss recruitment strategies. Minor (e.g., revised text, adapted materials to virtual format) and major adaptations (e.g., added and rearranged sessions) were made to FC-FORT and subsequently approved by the advisory board. Four family caregivers and three therapists took part in the first round of the usability testing. Six family caregivers and the same three therapists took part in the second round. Overall, participants were very satisfied with FC-FORT's usability. Qualitative analysis identified 4 key themes: usability of FC-FORT, satisfaction and engagement with content, group cohesion, and impact of FC-FORT. All participants indicated that they would recommend FC-FORT to others as is. Conclusions: Using a multidisciplinary advisory board, our team successfully adapted FC-FORT and tested its usability using videoconferencing. Results from this study indicate that the efficacy and acceptability of FC-FORT are now ready to be tested in a larger pilot study.

An Evaluation of Interactive mHealth Applications for Adults Living with Cancer.

This study evaluated the quality and usefulness of interactive mobile health (mHealth) applications (apps) for adults with cancer. The PRISMA guidelines were followed to add rigor to the search, as well as to the data collection and analysis. The apps available in the most used app stores (Google Play and Apple) with interactive tailored features were identified. To supplement this, a Google web search was also conducted. The apps were evaluated for their quality using the validated Mobile App Rating Scale (MARS) and for their usefulness using a checklist of end users' desired features derived from the literature. The searches returned 3046 apps and 17 were retained for evaluation. The average quality score of the apps across the sample was 3.62/5 (SD 0.26, range: 3.14-4.06), with Outcomes4me scoring the highest. On average, the apps scored 50% (SD 2.5, range: 31-88%) on the usefulness checklist, with Cancer.net scoring the highest. The lowest-scoring categories were communications features on the usefulness checklist and "information" on the MARS, indicating areas for future work. The findings identified the apps of an acceptable quality and usefulness that could be recommended to those with cancer.

An evaluation of the suitability, readability, quality, and usefulness of online resources for patients with cancer receiving immunotherapy.

OBJECTIVE: To evaluate the suitability, readability, quality, and usefulness of available online resources about the side effects of immunotherapy. METHODS: Resources were identified through online searches (Google, Microsoft Bing, and Yahoo search engines) and evaluated using the Suitability Assessment Materials (SAM), three readability formulae, the DISCERN tool (quality), and a checklist of symptom management strategies and self-management skills (usefulness). Hierarchical cluster analysis identified resources scoring highly for suitability and quality. Factors associated with the clusters were identified using Fischer's exact tests. RESULTS: The 51 resources retained for evaluation were of low suitability and quality and exceeded recommended reading levels. Resources were lacking key features to support learning (e.g., illustrations) as well as information about the risks of treatments and the effect of treatments on quality of life. Few resources addressed key self-management skills of problem-solving and taking action. The cluster analysis identified "low" and "moderate" clusters for suitability and quality, and pamphlets and booklets were more likely to be in the moderate cluster as compared to webpages. CONCLUSION: There is a lack of high-quality resources to support patients' learning to self-manage side effects of immunotherapy. PRACTICE IMPLICATIONS: Results identify the best available online resources for self-managing side effects of immunotherapy and gaps for future work. Based on findings, a template for patient education materials was developed.

Evaluation of quality, readability, suitability, and usefulness of online resources available to cancer survivors.

PURPOSE: The aim of this study was to evaluate the quality, readability, suitability, and usefulness of resources publicly available to adult cancer survivors (aged 18 +) who have completed primary treatment. METHODS: Resources were identified in July 2021 through Google. Search completeness was verified using Yahoo, Bing, and MedlinePlus. Retrieved resources were assessed for quality using the DISCERN, readability, suitability using the Suitability Assessment Measure (SAM), and usefulness based on a list of unmet needs and self-management skills derived from the literature. Descriptive analyses were conducted, and a cluster analysis identified the highest-scoring resources. RESULTS: Forty-five resources were included. The mean DISCERN score was fair at 63.3% (SD 13.7%) with low-rated items being sources, publication date, and risks and mechanisms of treatment. The mean reading grade level was 11.19 (SD 1.61, range 8-16) with only one resource scoring an 8. The mean SAM score was in the adequate range at 48.2% (SD 10.6%), with graphics being the lowest-rated section. On average, included resources addressed 57.7% (SD 27.3%) of the unmet needs and 48.4% (SD 20.9%) of the self-management skills, the least addressed being problem-solving. CONCLUSION: Quality and suitability were fair, whereas readability exceeded recommended levels. Only one resource had a superior score in both quality and suitability. IMPLICATIONS FOR CANCER SURVIVORS: The most pressing need is to develop resources for cancer survivors that address their unmet needs and are accessible in terms of literacy. Study findings outline the highest-scoring resources currently available to survivors, families, and clinicians.

Bayesian sample size calculations for comparing two strategies in SMART studies.

In the management of most chronic conditions characterized by the lack of universally effective treatments, adaptive treatment strategies (ATSs) have grown in popularity as they offer a more individualized approach. As a result, sequential multiple assignment randomized trials (SMARTs) have gained attention as the most suitable clinical trial design to formalize the study of these strategies. While the number of SMARTs has increased in recent years, sample size and design considerations have generally been carried out in frequentist settings. However, standard frequentist formulae require assumptions on interim response rates and variance components. Misspecifying these can lead to incorrect sample size calculations and correspondingly inadequate levels of power. The Bayesian framework offers a straightforward path to alleviate some of these concerns. In this paper, we provide calculations in a Bayesian setting to allow more realistic and robust estimates that account for uncertainty in inputs through the 'two priors' approach. Additionally, compared to the standard frequentist formulae, this methodology allows us to rely on fewer assumptions, integrate pre-trial knowledge, and switch the focus from the standardized effect size to the MDD. The proposed methodology is evaluated in a thorough simulation study and is implemented to estimate the sample size for a full-scale SMART of an internet-based adaptive stress management intervention on cardiovascular disease patients using data from its pilot study conducted in two Canadian provinces.

The Evaluation of the Suitability, Quality, and Readability of Publicly Available Online Resources for the Self-Management of Fear of Cancer Recurrence.

Cancer survivors often rely on the internet for health information, which has varying levels of readability, suitability, and quality. There is a need for high-quality online self-management resources for cancer survivors with fear of cancer recurrence (FCR). This study evaluated the readability, suitability, and quality of publicly available online FCR self-management resources. A Google search using FCR-related keywords identified freely available FCR self-management resources for cancer survivors in English. Resource readability (reading grade level), suitability, and quality were evaluated using relevant assessment tools. Descriptive statistics and cluster analysis identified resources with higher suitability and quality scores. Mean resource (n = 23) readability score was grade 11 (SD = 1.6, Range = 9-14). The mean suitability score was 56.0% (SD = 11.4%, Range = 31.0-76.3%), indicating average suitability and the mean quality score was 53% (SD = 11.7%, Range = 27-80%), indicating fair quality. A cluster of 15 (65%) resources with higher suitability and quality scores was identified. There were no significant associations between suitability or quality scores and the type of organisation that published the resources. Online FCR self-management resources varied in readability, suitability and quality. Resources with higher quality and suitability scores relative to other resources are identified for use by healthcare professionals and cancer survivors. Resources that are more culturally appropriate, with lower reading grade levels and detailed self-management strategies are needed.

Development and psychometric evaluation of the CanSmart questionnaire to measure chronic disease self-management tasks.

BACKGROUND: Psychometrically sound measures of chronic disease self-management tasks are needed to improve identification of patient needs and to tailor self-management programs. This study aimed to develop and conduct a preliminary psychometric analysis of the CanSMART questionnaire among a diverse, multimorbid Canadian population. METHODS: The data were drawn from a cross-sectional online survey to examine self-management needs and support preferences. Participants were 306 Canadian adults with one or more physical and/or emotional chronic conditions. The questionnaire on frequency of self-management tasks was developed with substantial patient partner input. We conducted Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) of the 11 self-management tasks comprising the scale in two randomly selected subsamples, followed by Rasch analysis. Associations between patient characteristics and the self-management task subscales and individual items were explored. RESULTS: The factor analyses identified two self-management task subscales that were labelled Coping tasks (6 items) and Physical tasks (3 items), with Cronbach's alpha of 0.70 and 0.67, respectively. Rasch analysis suggested that participants had difficulty discriminating between response options "mostly" and "always". In analyses of independent associations with patient characteristics, both Coping and Physical tasks were associated with reporting more than one chronic disease and employment disability. The Coping tasks subscale was associated with female sex. Two items, on medication use and monitoring biological parameters, did not load on either scale. Both were associated with specific diagnoses. CONCLUSIONS: In this preliminary analysis, two self-management tasks subscales exhibit good psychometric properties. Two items that did not load on either scale may represent additional dimensions of self-management. This work provides the basis for further scale development and use in research and clinical practice.

Healthcare professionals' perspectives on the unmet needs of cancer patients and family caregivers: global psycho-oncology investigation.

PURPOSE: This international study aimed to compare healthcare professionals' perspectives on the unmet needs of their cancer patients with those of family caregivers and to investigate the degree to which patients' age group moderates the associations. METHODS: Healthcare professionals involved in the care for cancer patients and their family caregivers were invited to participate in the International Psycho-Oncology Society (IPOS) Survivorship Online Survey. A total of 397 healthcare professionals from 34 countries provided valid study data. The participants evaluated whether the unmet need was the same for all age groups of patients and the degree of their patients' needs not being met per patients' age group. They evaluated the same questions for family caregivers. RESULTS: Patients' unmet needs in medical care were evaluated as greater than those of caregivers across all age groups. On the other hand, pediatric patients' unmet needs for spiritual concerns, sexuality/intimacy, and insomnia/fatigue were evaluated as greater than those of caregivers, whereas adolescent and young adult patients' unmet needs for symptom management were greater than those of caregivers. Patients' other unmet needs were evaluated as comparable with those of caregivers regardless of age groups. CONCLUSION: The findings provide insights how best healthcare providers stratify resources to address the unmet needs of patients and caregivers by the patients' age. Development of systematic assessment of unmet needs and provision of interventions tailored for patients' lifespan to address the unmet needs of cancer patients, and caregivers are warranted.

The Revised Identification of Seniors At Risk screening tool predicts readmission in older hospitalized patients: a cohort study.

BACKGROUND: The Identification of Seniors at Risk (ISAR) screening tool is a widely-used risk stratification tool for older adults in the emergency department (ED). Few studies have investigated the use of ISAR to predict outcomes of hospitalized patients. To improve usability a revised version of ISAR (ISAR-R), was developed in a quality improvement project. The ISAR-R is also widely used, although never formally validated. To address these two gaps in knowledge, we aimed to assess the ability of the ISAR-R to predict readmission in a cohort of older adults who were hospitalized (admitted from the ED) and discharged home. METHODS: This was a secondary analysis of data collected in a pre-post evaluation of a patient discharge education tool. Participants were patients aged 65 and older, admitted to hospital via the ED of two general community hospitals, and discharged home from the medical and geriatric units of these hospitals. Patients (or family caregivers for patients with mental or physical impairment) were recruited during their admission. The ISAR-R was administered as part of a short in-hospital interview. Providers were blinded to ISAR-R scores. Among patients discharged home, 90-day readmissions were extracted from hospital administrative data. The primary metrics of interest were sensitivity and negative predictive value. The Area Under the Curve (AUC) was also computed as an overall measure of performance. RESULTS: Of 711 attempted recruitments, 496 accepted, and ISAR-R was completed for 485. Of these 386 patients were discharged home with a complete ISAR-R, the 90-day readmission rate was 24.9%; the AUC was 0.63 (95% CI 0.57,0.69). Sensitivity and negative predictive value at the recommended cut-point of 2 + were 81% and 87%, respectively. Specificity was low (40%). CONCLUSIONS: The ISAR-R tool is a potentially useful risk stratification tool to predict patients at increased risk of readmission. Its high values of sensitivity and negative predictive value at a cut-point of 2 + make it suitable for rapid screening of patients to identify those suitable for assessment by a clinical geriatric team, who can identify those with geriatric problems requiring further treatment, education, and follow-up to reduce the risk of readmission.

Measuring Health Literacy in Primary Healthcare: Adaptation and Validation of a French-Language Version of the Brief Health Literacy Screening among Patients with Chronic Conditions Seen in Primary Care.

BACKGROUND: The Brief Health Literacy Screening (BHLS) is a short self-report instrument developed to identify patients with inadequate health literacy. This study aimed to translate the BHLS into French Canadian (BHLS-FCv) and to evaluate its psychometric properties among patients with chronic conditions in primary care. METHODS: The BHLS was translated into French using the Hawkins and Osborne's method. Content validity was evaluated through cognitive interviews. A validation study of the BHLS-FCv was conducted in two primary care clinics in the province of Quebec (Canada) among adult patients with chronic conditions. Psychometric properties evaluated included: internal consistency (Cronbach's alpha); test-retest reliability (intraclass correlation coefficient); and concurrent validity (Spearman's correlations with the Health Literacy Questionnaire (HLQ)). RESULTS: 178 participants completed the questionnaire at baseline and 47 completed the questionnaire two weeks later over the telephone. The average score was 13.3. Cronbach's alpha for internal consistency was 0.77. The intraclass correlation coefficient for test-retest reliability was 0.69 (95% confidence interval: 0.45-0.83). Concurrent validity with Spearman's correlation coefficient with three subscales of HLQ ranged from 0.28 to 0.58. CONCLUSIONS: The BHLS-FCv demonstrated acceptable psychometric properties and could be used in a population with chronic conditions in primary care.

Convergent and criterion validity of PROMIS anxiety measures relative to six legacy measures and a structured diagnostic interview for anxiety in cancer patients.

BACKGROUND: Detecting anxiety in oncology patients is important, requiring valid yet brief measures. One increasingly popular approach is the Patient Reported Outcomes Measurement Information System (PROMIS); however, its validity is not well established in oncology. We assessed the convergent and criterion validity of PROMIS anxiety measures in an oncology sample. METHODS: 132 oncology/haematology outpatients completed the PROMIS Anxiety Computer Adaptive Test (PROMIS-A-CAT) and the 7 item (original) PROMIS Anxiety Short Form (PROMIS-A-SF) along with six well-established measures: Hospital Anxiety and Depression Scale-Anxiety (HADS-A); Generalised Anxiety Disorder-7 (GAD-7); Depression, Anxiety and Stress Scale-Anxiety (DASS-A) and Stress (DASS-S); Distress Thermometer (DT) and PSYCH-6. Correlations, area under the curve (AUC) and diagnostic accuracy statistics were calculated with Structured Clinical Interview as the reference standard. RESULTS: Both PROMIS measures correlated with all legacy measures at p < .001 (Rho = .56-.83). AUCs (> .80) were good for both PROMIS measures and comparable to or better than all legacy measures. At the recommended mild cut-point (55), PROMIS-A-SF had sensitivity (.67) comparable to or better than all the legacy measures, whereas PROMIS-A-CAT sensitivity (.59) was lower than GAD-7 (.67) and HADS-A (.62), but comparable to PSYCH-6 and higher than DASS-A, DASS-S and DT. Sensitivity for both was .79. A reduced cut-point of 51 on both PROMIS measures improved sensitivity (.83-.84) although specificity was only adequate (.61-.62). CONCLUSIONS: The convergent and criterion validity of the PROMIS anxiety measures in cancer populations was confirmed as equivalent, but not superior to, established measures (GAD-7 and HADS-A). The PROMIS-A-CAT did not demonstrate clear advantages over PROMIS-A-SF.

Trained lay coaches and self-care cognitive-behavioral tools improve depression outcomes.

OBJECTIVES: Identify the key effective components of a depression self-care intervention. METHODS: Secondary analysis of data from 3 studies that demonstrated effectiveness of a similar depression self-care intervention (n = 275): 2 studies among patients with chronic physical conditions and 1 among cancer survivors. The studies used similar tools, and telephone-based lay coaching. Depression remission and reduction at 6 months were assessed with either PHQ-9 (chronic condition cohorts) or CES-D (cancer survivor cohort). Multiple logistic regression was used to analyze data when the interaction p-value with cohort was < 0.10. RESULTS: The 3 coached cohorts achieved better depression outcomes than usual care. The combination of coaching and joint use of 2 tools based on cognitive-behavioral therapy (CBT) was associated with depression remission and reduction among chronic condition cohorts but not among cancer survivors. Neither the number nor the length of coach calls were associated with outcomes in pooled data. CONCLUSIONS: Trained lay coaching and use of CBT-based self-care tools were associated with improved depression outcomes in patients with chronic conditions but not among cancer survivors. PRACTICE IMPLICATIONS: Trained lay coaching and CBT tools are key components of depression self-care interventions. Further research is needed on the effective components in cancer survivors.

Feasibility, Acceptability, and Clinical Significance of a Dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program (TEMPO) Tailored to the Needs of Men with Prostate Cancer and Their Caregivers: A Multi-Center Randomized Pilot Trial.

BACKGROUND: Prostate cancer is the most common cancer diagnosis among men. Family caregivers (often female spouses) play a key role in ensuring patients' needs are met, frequently assuming their role with no formal training, which can contribute to a high burden. The purpose of this study was to pilot TEMPO-the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram for men with prostate cancer and their caregivers. METHODS: 49 men with prostate cancer and their caregivers were randomized to TEMPO or usual care. Baseline and follow-up questionnaires were completed to assess feasibility, acceptability, and clinical significance. A priori benchmarks for these outcomes were set. Thirteen exit interviews were conducted to further explore acceptability. RESULTS: Feasibility benchmarks were met with the exception for recruitment with on average 6.1 dyads recruited/month (benchmark: 8 dyads/month). Benchmarks of acceptability focused on attrition (<25%) and system usability, which were met. Using the strict criteria for adherence of 100% of the module viewed and participants spending at least 15 min on the module, 45% of participants were adherent. The clinical significance on anxiety and quality of life was supported for caregivers, and mostly supported for the men with prostate cancer. CONCLUSION: This pilot trial was successful, with minor modifications needed prior to a large trial.

Adaptive web-based stress management programs among adults with a cardiovascular disease: A pilot Sequential Multiple Assignment Randomized Trial (SMART).

OBJECTIVE: To assess the feasibility and acceptability of using a Sequential Multiple Assignment Randomized Trial (SMART) to optimize the delivery of a web-based, stress management intervention for patients with a cardiovascular disease (CVD). METHODS: 59 patients with a CVD and moderate stress were randomized to a self-directed web-based stress management program (n = 30) or the same intervention plus lay telephone coaching (n = 29). After 6 weeks, non-responders were re-randomized to continue with their initial intervention or switched to motivational interviewing (MI). Feasibility, acceptability, and clinical significance were assessed. RESULTS: SMART procedures were feasible. Attrition rates were almost twice as high in the web-only group than the lay coach group. This might be because of the low satisfaction (47%) in the web-only group. On average, 1.7/5 modules were completed. Effect sizes for stress and quality of life generally exceeded 0.2 (clinical benchmark), except for the group that initially received lay coaching and then switched to MI. CONCLUSIONS: Results suggest that a larger trial would be feasible. Issues pertaining to attrition and satisfaction for non-responders need to be addressed. PRACTICE IMPLICATIONS: Findings contribute to the evidence on how best to develop and deliver e-Health interventions to maximize their efficacy while remaining cost-effective.

An Evaluation of Publicly Available Smartphone Apps to Support Unpaid Cancer Caregivers.

CONTEXT: With advancements in mobile technology and increased access to smartphones, the use of Mobile Health applications (apps) has surged. These apps provide an innovative avenue for supporting cancer caregivers who face increasing burden and lack formal support; however, the quality of these apps has not been formally evaluated. OBJECTIVES: Evaluate the quality, usefulness, therapeutic potential, and security of publicly available apps to support unpaid cancer caregivers in managing their roles and responsibilities. METHODS: Cancer caregiving apps were identified through a search of the Apple and Google Play stores in October 2020. Two authors evaluated the apps using 1) the Mobile App Rating Scale (MARS) tool for quality, 2) complementary sections of Enlight for therapeutic persuasiveness and alliance, security and privacy, and 3) an unmet needs checklist to assess usefulness. Analyses were undertaken to identify high-scoring apps. RESULTS: Overall, 24 apps were evaluated by two authors (MB, SW). Across the sample, the mean quality score (MARS) was adequate at 65.7% (3.3/5.0, SD = .5, range: 2.3-4.2). The combined score for therapeutic persuasiveness and alliance (Enlight) was fair at 60.7% (3.0/5.0, SD = .8, range: 1.1-4.5), and the privacy and security checklists yielded means of 79.3% (6.3/8.0, SD = 1.4, range: 50.0%-100.0%) and 41.3% (1.7/4.0, SD = 1.4, range: 0.0-100.0%), respectively. The unmet needs checklist was 43.2% (SD = 5.3, range: 9.4%-69.7%). A hierarchical cluster analysis identified 12 high scoring apps. CONCLUSION: Superior cluster apps scored acceptably for quality and privacy and low for security and usefulness. Findings will assist clinicians, caregivers, and families identify apps to support cancer caregivers.

The effects of self-management interventions on depressive symptoms in adults with chronic physical disease(s) experiencing depressive symptomatology: a systematic review and meta-analysis.

BACKGROUND: Chronic diseases are the leading cause of death worldwide. It is estimated that 20% of adults with chronic physical diseases experience concomitant depression, increasing their risk of morbidity and mortality. Low intensity psychosocial interventions, such as self-management, are part of recommended treatment; however, no systematic review has evaluated the effects of depression self-management interventions for this population. The primary objective was to examine the effect of self-management interventions on reducing depressive symptomatology in adults with chronic disease(s) and co-occurring depressive symptoms. Secondary objectives were to evaluate the effect of these interventions on improving other psychosocial and physiological outcomes (e.g., anxiety, glycemic control) and to assess potential differential effect based on key participant and intervention characteristics (e.g., chronic disease, provider). METHODS: Studies comparing depression self-management interventions to a control group were identified through a) systematic searches of databases to June 2018 [MEDLINE (1946 -), EMBASE (1996 -), PsycINFO (1967 -), CINAHL (1984 -)] and b) secondary 'snowball' search strategies. The methodological quality of included studies was critically reviewed. Screening of all titles, abstracts, and full texts for eligibility was assessed independently by two authors. Data were extracted by one author and verified by a second. RESULTS: Fifteen studies were retained: 12 for meta-analysis and three for descriptive review. In total, these trials included 2064 participants and most commonly evaluated interventions for people with cancer (n = 7) or diabetes (n = 4). From baseline to < 6-months (T1), the pooled mean effect size was - 0.47 [95% CI -0.73, - 0.21] as compared to control groups for the primary outcome of depression and - 0.53 [95% CI -0.91, - 0.15] at ≥ 6-months (T2). Results were also significant for anxiety (T1) and glycemic control (T2). Self-management skills of decision-making and taking action were significant moderators of depression at T1. CONCLUSION: Self-management interventions show promise in improving depression and anxiety in those with concomitant chronic physical disease. The findings may contribute to the development of future Self-management interventions and delivering evidence-based care to this population. Further high-quality RCTs are needed to identify sources of heterogeneity and investigate key intervention components.

A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers.

BACKGROUND: Prostate cancer predisposes patients and caregivers to a wide range of complex physical and psychosocial challenges, and interventions must incorporate a wide range of self-management strategies to help patients and their caregivers effectively cope with cancer challenges. To palliate this need, our team recently developed and evaluated the initial acceptability of a dyadic, Tailored, wEb-based, psychosocial, and physical activity self-Management PrOgram (TEMPO). TEMPO is a 10-week, interactive, web-based intervention consisting of five modules designed to help dyads manage their physical and psychosocial needs. It aims to teach dyads new self-management strategies and encourages them to increase their physical activity (PA) levels, mainly through walking and strength-based exercises. Initial acceptability evaluation of TEMPO revealed high user satisfaction, in addition to having a number of potential benefits for participants. After integrating suggested changes to TEMPO, the proposed pilot study aims to further test the acceptability and feasibility of TEMPO. METHODS: This study is a multicenter, stratified, parallel, two-group, pilot randomized control trial (RCT), where patient-caregiver dyads are randomized (stratified by anxiety level) to receive (a) TEMPO or (b) usual care. Participants (n goal = 40) are recruited across Canada at participating cancer centers and through self-referral (e.g., online recruitment). Patient inclusion criteria are (a) having received prostate cancer treatment within the past 2 years or scheduled to receive treatment, (b) identified a primary caregiver willing to participate in the study, and (c) has access to the Internet. Eligible caregivers are those identified by the patient as his primary source of support. Dyads complete a baseline questionnaire (T1) and another one 3 months later (T2) assessing various aspects of physical and emotional functioning (e.g., the Medical Outcomes Study (MOS) 12-item Short Form Health Survey (SF-12), the Hospital Anxiety and Depression Scale (HADS), and the Perceived Stress Scale (PSS)), self-management behaviors (e.g., the Health Education Impact Questionnaire (heiQ)), physical activity (the International Physical Activity Questionnaires (IPAQ) and the Multidimensional Self-efficacy for Exercise Scale (MSES)), and dyadic coping (the Dyadic Coping Inventory (DCI)). Dyads that used TEMPO are also asked to participate in a semi-structured exit interview exploring their overall experience with the program. DISCUSSION: This feasibility analysis will begin to develop the knowledge base on TEMPO's value for men with prostate cancer and their caregivers to inform a larger trial. TRIAL REGISTRATION: NCT04304196.