A Framework for Integrating Telehealth Equitably across the cancer care continuum.

The COVID-19 pandemic placed a spotlight on the potential to dramatically increase the use of telehealth across the cancer care continuum, but whether and how telehealth can be implemented in practice in ways that reduce, rather than exacerbate, inequities are largely unknown. To help fill this critical gap in research and practice, we developed the Framework for Integrating Telehealth Equitably (FITE), a process and evaluation model designed to help guide equitable integration of telehealth into practice. In this manuscript, we present FITE and showcase how investigators across the National Cancer Institute's Telehealth Research Centers of Excellence are applying the framework in different ways to advance digital and health equity. By highlighting multilevel determinants of digital equity that span further than access alone, FITE highlights the complex and differential ways structural determinants restrict or enable digital equity at the individual and community level. As such, achieving digital equity will require strategies designed to not only support individual behavior but also change the broader context to ensure all patients and communities have the choice, opportunity, and resources to use telehealth across the cancer care continuum.

Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment.

Northwestern University's Center for Scalable Telehealth Cancer Care (STELLAR) is 1 of 4 Cancer Moonshot Telehealth Research Centers of Excellence programs funded by the National Cancer Institute to establish an evidence base for telehealth in cancer care. STELLAR is grounded in the Institute of Medicine's vision that quality cancer care includes not only disease treatment but also promotion of long-term health and quality of life (QOL). Cigarette smoking, insufficient physical activity, and overweight and obesity often co-occur and are associated with poorer treatment response, heightened recurrence risk, decreased longevity, diminished QOL, and increased treatment cost for many cancers. These risk behaviors are prevalent in cancer survivors, but their treatment is not routinely integrated into oncology care. STELLAR aims to foster patients' long-term health and QOL by designing, implementing, and sustaining a novel telehealth treatment program for multiple risk behaviors to be integrated into standard cancer care. Telehealth delivery is evidence-based for health behavior change treatment and is well suited to overcome access and workflow barriers that can otherwise impede treatment receipt. This paper describes STELLAR's 2-arm randomized parallel group pragmatic clinical trial comparing telehealth-delivered, coach-facilitated multiple risk behavior treatment vs self-guided usual care for the outcomes of reach, effectiveness, and cost among 3000 cancer survivors who have completed curative intent treatment. This paper also discusses several challenges encountered by the STELLAR investigative team and the adaptations developed to move the research forward.

The Health4Life e-health intervention for modifying lifestyle risk behaviours of adolescents: secondary outcomes of a cluster randomised controlled trial.

OBJECTIVES: To investigate the effectiveness of a school-based multiple health behaviour change e-health intervention for modifying risk factors for chronic disease (secondary outcomes). STUDY DESIGN: Cluster randomised controlled trial. SETTING, PARTICIPANTS: Students (at baseline [2019]: year 7, 11-14 years old) at 71 Australian public, independent, and Catholic schools. INTERVENTION: Health4Life: an e-health school-based multiple health behaviour change intervention for reducing increases in the six major behavioural risk factors for chronic disease: physical inactivity, poor diet, excessive recreational screen time, poor sleep, and use of alcohol and tobacco. It comprises six online video modules during health education class and a smartphone app. MAIN OUTCOME MEASURES: Comparison of Health4Life and usual health education with respect to their impact on changes in twelve secondary outcomes related to the six behavioural risk factors, assessed in surveys at baseline, immediately after the intervention, and 12 and 24 months after the intervention: binge drinking, discretionary food consumption risk, inadequate fruit and vegetable intake, difficulty falling asleep, and light physical activity frequency (categorical); tobacco smoking frequency, alcohol drinking frequency, alcohol-related harm, daytime sleepiness, and time spent watching television and using electronic devices (continuous). RESULTS: A total of 6640 year 7 students completed the baseline survey (Health4Life: 3610; control: 3030); 6454 (97.2%) completed at least one follow-up survey, 5698 (85.8%) two or more follow-up surveys. Health4Life was not statistically more effective than usual school health education for influencing changes in any of the twelve outcomes over 24 months; for example: fruit intake inadequate: odds ratio [OR], 1.08 (95% confidence interval [CI], 0.57-2.05); vegetable intake inadequate: OR, 0.97 (95% CI, 0.64-1.47); increased light physical activity: OR, 1.00 (95% CI, 0.72-1.38); tobacco use frequency: relative difference, 0.03 (95% CI, -0.58 to 0.64) days per 30 days; alcohol use frequency: relative difference, -0.34 (95% CI, -1.16 to 0.49) days per 30 days; device use time: relative difference, -0.07 (95% CI, -0.29 to 0.16) hours per day. CONCLUSIONS: Health4Life was not more effective than usual school year 7 health education for modifying adolescent risk factors for chronic disease. Future e-health multiple health behaviour change intervention research should examine the timing and length of the intervention, as well as increasing the number of engagement strategies (eg, goal setting) during the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12619000431123 (prospective).

Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial.

Background Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. Methods The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6-minute walk distance at 12-month follow-up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12-month change in 6-minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12-month follow-up and 12-month change in accelerometer-measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient-Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12-month changes in perceived exertional effort at the end of the 6-minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. Conclusions The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04228978.

U.S. Vietnamese parents' trusted sources of information and preferences for intervention messaging about HPV vaccination: A mixed methods study.

Objective: Assess trusted sources of information, perceived message effectiveness, and preferred dissemination strategies regarding adolescent HPV vaccination among U.S. Vietnamese parents. Methods: Data came from an observational, explanatory sequential mixed-methods study with U.S. Vietnamese parents of adolescents (408 survey participants; 32 interview participants). Surveys and interviews were conducted in both Vietnamese and English. Mixed-methods data were integrated and analyzed for confirmation, expansion, or discordance. Results: Both quantitative and qualitative findings confirm high trust in HPV vaccination information from providers, government agencies, and cancer organizations. Messages perceived as effective emphasize vaccine safety, experts' endorsement, importance of vaccination prior to HPV exposure, and preventable cancers. Qualitative findings expanded quantitative results, demonstrating a desire for evidence-based information in the Vietnamese language and addressing cultural concerns (e.g., effectiveness or potential side effects specific to Vietnamese adolescents, whether parents should delay HPV vaccination for Vietnamese adolescents). Quantitative and qualitative findings were incongruent about whether parents would trust information about HPV vaccination that is disseminated via social media. Conclusion: We identified credible messengers, feasible strategies, and elements of impactful messages for interventions to increase adolescent HPV vaccination for U.S. Vietnamese. Innovation: We focus on a high-risk, underserved population and integrate mixed-methods design and analysis.

Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial.

BACKGROUND: Moderate to vigorous physical activity (MVPA) interventions improve patient-reported outcomes (PROs) of physical and psychological health among breast cancer survivors (BCS); however, the effects of specific intervention components on PROs are unknown. PURPOSE: To use the Multiphase Optimization Strategy (MOST) to examine overall effects of the Fit2Thrive MVPA promotion intervention on PROs in BCS and explore whether there are intervention component-specific effects on PROs. METHODS: Physically inactive BCS [n = 269; Mage = 52.5 (SD = 9.9)] received a core intervention (Fitbit + Fit2Thrive smartphone app) and were randomly assigned to one of 32 conditions in a full factorial experiment of five components ("on" vs. "off"): (i) support calls, (ii) deluxe app, (iii) text messages, (iv) online gym, and (v) buddy. Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires assessed anxiety, depression, fatigue, physical functioning, sleep disturbance and sleep-related impairment at baseline, post-intervention (12-week), and 24-week follow-up. Main effects for all components at each time point were examined using an intention to treat mixed-effects model. RESULTS: All PROMIS measures except sleep disturbance significantly improved (p's < .008 for all) from baseline to 12-weeks. Effects were maintained at 24-weeks. The "on" level of each component did not result in significantly greater improvements on any PROMIS measure compared to the "off" level. CONCLUSIONS: Participation in Fit2Thrive was associated with improved PROs in BCS, but improvements did not differ for "on" vs. "off" levels for any component tested. The low-resource Fit2Thrive core intervention is a potential strategy to improve PROs among BCS. Future studies should test the core in an RCT and examine various intervention component effects in BCS with clinically elevated PROs.

Health4Life eHealth intervention to modify multiple lifestyle risk behaviours among adolescent students in Australia: a cluster-randomised controlled trial.

BACKGROUND: Lifestyle risk behaviours are prevalent among adolescents and commonly co-occur, but current intervention approaches tend to focus on single risk behaviours. This study aimed to evaluate the efficacy of the eHealth intervention Health4Life in modifying six key lifestyle risk behaviours (ie, alcohol use, tobacco smoking, recreational screen time, physical inactivity, poor diet, and poor sleep, known as the Big 6) among adolescents. METHODS: We conducted a cluster-randomised controlled trial in secondary schools that had a minimum of 30 year 7 students, in three Australian states. A biostatistician randomly allocated schools (1:1) to Health4Life (a six-module, web-based programme and accompanying smartphone app) or an active control group (usual health education) with the Blockrand function in R, stratified by site and school gender composition. All students aged 11-13 years who were fluent in English and attended participating schools were eligible. Teachers, students, and researchers were not masked to allocation. Primary outcomes were alcohol use, tobacco use, recreational screen time, moderate to vigorous physical activity (MVPA), sugar-sweetened beverage intake, and sleep duration at 24 months, measured by self-report surveys, and analysed in all students who were eligible at baseline. Latent growth models estimated between-group change over time. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000431123). FINDINGS: Between April 1, 2019, and Sept 27, 2019, we recruited 85 schools (9280 students), of which 71 schools with 6640 eligible students (36 schools [3610 students] assigned to the intervention and 35 [3030 students] to the control) completed the baseline survey. 14 schools were excluded from the final analysis or withdrew, mostly due to a lack of time. We found no between-group differences for alcohol use (odds ratio 1·24, 95% CI 0·58-2·64), smoking (1·68, 0·76-3·72), screen time (0·79, 0·59-1·06), MVPA (0·82, 0·62-1·09), sugar-sweetened beverage intake (1·02, 0·82-1·26), or sleep (0·91, 0·72-1·14) at 24 months. No adverse events were reported during this trial. INTERPRETATION: Health4Life was not effective in modifying risk behaviours. Our results provide new knowledge about eHealth multiple health behaviour change interventions. However, further research is needed to improve efficacy. FUNDING: Paul Ramsay Foundation, the Australian National Health and Medical Research Council, the Australian Government Department of Health and Aged Care, and the US National Institutes of Health.

Parental Information Needs and Intervention Preferences for Preventing Multiple Lifestyle Risk Behaviors Among Adolescents: Cross-sectional Survey Among Parents.

BACKGROUND: Parents play an influential role in the health behaviors of their children, such as physical activity, dietary intake, sleep, screen time, and substance use. However, further research is needed to inform the development of more effective and engaging parent-based interventions targeting adolescent risk behaviors. OBJECTIVE: This study aimed to assess parents' knowledge about adolescent risk behaviors, barriers and facilitators to engaging in healthy behaviors, and preferences for a parent-based prevention intervention. METHODS: An anonymous web-based survey was conducted from June 2022 to August 2022. Eligible participants were parents of children aged 11 to 18 years and were residing in Australia at the time of this study. The survey assessed the parents' perceived and actual knowledge about Australian health guidelines for youth, parent and adolescent engagement in health behaviors, parenting style and attitudes, barriers and facilitators to engaging in healthy behaviors, and delivery and component preferences for a parent-based preventive intervention. Descriptive statistics and logistic regressions were conducted to analyze the data. RESULTS: A total of 179 eligible participants completed the survey. The mean age of the parents was 42.22 (SD 7.03) years, and 63.1% (101/160) were female. Parent-reported sleep duration was high for both parents (mean 8.31, SD 1.00 hours) and adolescents (mean 9.18, SD 0.94 hours). However, the proportion of parents who reported that their child met the national recommendations for physical activity (5/149, 3.4%), vegetable intake (7/126, 5.6%), and weekend recreational screen time (7/130, 5.4%) was very low. Overall, parents' perceived knowledge of health guidelines was moderate, ranging from 50.6% (80/158) for screen time to 72.8% (115/158) for sleep guidelines (for children aged 5-13 years). Actual knowledge was lowest for vegetable intake and physical activity, with only 44.2% (46/104) and 42% (31/74) of parents reporting correct guidelines for these behaviors, respectively. The key issues of concern reported by parents were excessive use of technology, mental health, e-cigarette use, and negative peer relationships. The top-rated delivery method for a parent-based intervention was via a website (53/129, 41.1%). The highest rated intervention component was opportunities for goal-setting (89/126, 70.7% rated very or extremely important), and other important program features were ease of use (89/122, 72.9%), paced learning (79/126, 62.7%), and appropriate program length (74/126, 58.8%). CONCLUSIONS: The findings suggest that such interventions should be brief and web based and should aim to increase parental knowledge of health guidelines; provide opportunities for skill-building, such as goal-setting; and include effective behavior change techniques, such as motivational interviewing and social support. This study will inform the development of future parent-based preventive interventions to prevent multiple lifestyle risk behaviors among adolescents.

A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol.

Despite the known benefits of moderate-to-vigorous physical activity (MVPA) for breast and endometrial cancer survivors, most are insufficiently active, interventions response is heterogeneous, and MVPA programming integration into cancer care is limited. A stepped care approach, in which the least resource-intensive intervention is delivered first and additional components are added based on individual response, is one strategy to enhance uptake of physical activity programming. However, the most effective intervention augmentation strategies are unknown. In this singly randomized trial of post-treatment, inactive breast and endometrial cancer survivors (n = 323), participants receive a minimal intervention including a Fitbit linked with their clinic's patient portal and, in turn, the electronic health record (EHR) with weekly feedback delivered via the portal. MVPA progress summaries are sent to participants' oncology team via the EHR. MVPA adherence is evaluated at 4, 8, 12, 16 and 20 weeks; non-responders (those meeting ≤80% of the MVPA goal over previous 4 weeks) at each timepoint are randomized once for the remainder of the 24-week intervention to one of two "step-up" conditions: (1) online gym or (2) coaching calls, while responders continue with the minimal Fitbit+EHR intervention. The primary outcome is ActiGraph-measured MVPA at 24 and 48 weeks. Secondary outcomes include symptom burden and functional performance at 24 and 48 weeks. This trial will inform development of an effective, scalable, and tailored intervention for survivors by identifying non-responders and providing them with the intervention augmentations necessary to increase MVPA and improve health outcomes. Clinical Trials Registration # NCT04262180.

Effect of time-restricted eating on sex hormone levels in premenopausal and postmenopausal females.

OBJECTIVE: Concerns have been raised regarding the impact of time-restricted eating (TRE) on sex hormones in females. This study examined how TRE affects sex steroids in premenopausal and postmenopausal females. METHODS: This is a secondary analysis of an 8-week TRE study (4- to 6-hour eating window) conducted in adults with obesity. Men and perimenopausal females were excluded. Females were classified into two groups based on menstrual status: premenopausal (n = 12) or postmenopausal (n = 11). RESULTS: After 8 weeks, body weight decreased in premenopausal females (-3% ± 2%) and postmenopausal females (-4% ± 2%) (main effect of time, p < 0.001), with no difference between groups (no group × time interaction). Circulating levels of testosterone, androstenedione, and sex hormone binding globulin (SHBG) did not change in either group (no group × time interaction). Dehydroepiandrosterone (DHEA) concentrations decreased (p < 0.05) in premenopausal (-14% ± 32%) and postmenopausal females (-13% ± 34%; main effect of time, p = 0.03), with no difference between groups. Estradiol, estrone, and progesterone were measured only in postmenopausal females, and they remained unchanged. CONCLUSIONS: In premenopausal females, androgens and SHBG remained unchanged during TRE, whereas DHEA decreased. In postmenopausal females, estrogens, progesterone, androgens, and SHBG did not change, but DHEA was reduced.

Validation and results of a novel survey assessing decisional balance for a whole food plant-based diet among US adults.

Importance: Consuming a whole food plant-based diet (WFPBD) is a promising, low-risk strategy for reducing risk of prevalent chronic disease and certain cancers, with synergistic benefits for climate and environment. However, few US adults report consuming a WFPBD. Understanding the reasons for this inconsistency is important for developing and implementing interventions for promoting a WFPBD. However, no research to elucidate decisional balance driving current consumption patterns in the US exists. Objective: This research aims to validate an online survey to assess decisional balance for the consumption of a WFPBD, describe attitudes and beliefs toward adopting a WFPBD, and evaluate socio-demographic differences in decisional balance for consuming a WFPBD among a convenience sample of US adults. Design: Online cross-sectional data collection followed by confirmatory factor analysis (CFA), validation of internal consistency, and examination of invariance across socio-demographic variables. Sensitivity analysis of full vs. truncated survey to predict self-reported dietary patterns and consumption behaviors were evaluated. Results of the survey and significant differences by socio-demographics were assessed. Setting: Online survey based on previous research, created via Qualtrics, and administered through MTurk. Participants: A total of 412 US adults, majority female (66%), White (75%), 30-60 years old (54%), ≥ Bachelor's degree (85%), and earning ≥ $45K (68%). Main outcomes and measures: Factor loadings, covariance of survey items, associations with self-reported dietary pattern and consumption measures, and differences in pros, cons, and decisional balance across socio-demographic variables. Results: CFA reduced the survey from 49 to 12 items and demonstrated invariance across socio-demographic variables. Pros and cons varied inversely and significantly (cov = -0.59), as expected. Cronbach's α 's for subscales in the final, reduced model were high (>0.80). Pros, cons, and decisional balance in both the full and the reduced model were significantly (p < 0.05) associated with self-reported dietary pattern and consumption. Conclusion and relevance: Our analyses indicate the WFPBD Survey is a parsimonious and psychometrically sound instrument for evaluation of decisional balance to consume a WFPBD diet among our sample of US adults. These results may be instrumental for development and deployment of interventions intended to promote consumption of a WFPBD in the US.

Parent-based interventions to improve multiple lifestyle risk behaviors among adolescents: A systematic review and meta-analysis.

Lifestyle risk behaviors often co-occur and are prevalent among adolescents. Parent-based interventions addressing risk behaviors concurrently have the potential to improve youth and parent outcomes. This systematic review evaluated the efficacy of parent-based interventions targeting multiple lifestyle risk behaviors among adolescents and parents. MEDLINE (Ovid), Embase (Ovid), PsycInfo (Ovid), Scopus, CINAHL, the Cochrane Database of Systematic Reviews (CDSR) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 2010-May 2021. Eligible studies were randomised controlled trials (RCTs) of parent-based interventions addressing 2+ risk behaviors: alcohol use, smoking, poor diet, physical inactivity, sedentary behaviors, and poor sleep. Studies directly targeting parents, and that assessed adolescent outcomes (11-18 years) were eligible. Where possible, random-effects meta-analysis was conducted. From 11,975 identified records, 46 publications of 36 RCTs (n = 28,322 youth, n = 7385 parents) were eligible. Parent-based interventions were associated with improved adolescent moderate-to-vigorous physical activity (MVPA) [Odds Ratio (OR) = 1.82, 95% CI = 1.18, 2.81; p = 0.007], and reduced screen time (SMD = -0.39, 95% CI = -0.62, -0.16, p = 0.0009) and discretionary food intake (SMD = -0.18; 95% CI = -0.30, -0.06; p = 0.002) compared to controls. However, there was some evidence that interventions increased the odds of ever using tobacco in the medium-term (OR = 1.47, 95% CI = 0.99, 2.18, p = 0.06) and of past month tobacco use in the long-term (OR = 1.46, 95% CI = 1.12, 1.90; p = 0.005). Overall, the quality of evidence was moderate. Parent-based interventions targeting multiple risk behaviors improved adolescent MVPA, and reduced screen time discretionary food intake. Further research is needed to address sleep problems and increase intervention efficacy, particularly for alcohol and tobacco use.

Mobile Health Tobacco Cessation Interventions to Promote Health Equity: Current Perspectives.

Although US tobacco use trends show overall improvement, social disadvantage continues to drive significant disparities. Traditional tobacco cessation interventions and public policy initiatives have failed to equitably benefit socially-disadvantaged populations. Advancements in mobile digital technologies have created new opportunities to develop resource-efficient mobile health (mHealth) interventions that, relative to traditional approaches, have greater reach while still maintaining comparable or greater efficacy. Their potential for affordability, scalability, and efficiency gives mHealth tobacco cessation interventions potential as tools to help redress tobacco use disparities. We discuss our perspectives on the state of the science surrounding mHealth tobacco cessation interventions for use by socially-disadvantaged populations. In doing so, we outline existing models of health disparities and social determinants of health (SDOH) and discuss potential ways that mHealth interventions might be optimized to offset or address the impact of social determinants of tobacco use. Because smokers from socially-disadvantaged backgrounds face multi-level barriers that can dynamically heighten the risks of tobacco use, we discuss cutting-edge mHealth interventions that adapt dynamically based on context. We also consider complications and pitfalls that could emerge when designing, evaluating, and implementing mHealth tobacco cessation interventions for socially-disadvantaged populations. Altogether, this perspective article provides a conceptual foundation for optimizing mHealth tobacco cessation interventions for the socially-disadvantaged populations in greatest need.

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol.

The Lupus Intervention Fatigue Trial (LIFT) is a prospective, randomized controlled trial to assess the effectiveness of a six-month motivational interviewing intervention program versus an educational control to reduce fatigue in persons with systematic lupus erythematosus (SLE). Participants are randomized using a stratified, 1:1 allocation design to the LIFT intervention or control arm. We plan to enroll 236 participants to achieve the target of 200 persons with six-month follow-up for the primary endpoint. Specific aims of this study are to evaluate the impact of the LIFT intervention on 1) self-reported measures of fatigue and 2) impact on accelerometer-measured physical activity. The primary study outcome is six-month change in fatigue from baseline, assessed by the Fatigue Severity Score (FSS). Additional outcomes include objective measures of physical activity, including non-sedentary behavior and moderate-to-vigorous activity (secondary outcome), and adherence to the LIFT dietary intervention, as assessed by nutrient density (diet quality) and recommended food groups/eating patterns (exploratory outcome) in persons with SLE. Intervention effectiveness will be assessed using an intention-to-treat two-arm comparison of six-month change in FSS, with one interim monitoring analysis. A two-sample independent group t-test will compare the six-month changes in FSS between the study arms. Intervention effect durability will be assessed 12-months after baseline (6 months after completion of the intervention). Enrollment began in June 2019 and is expected to end in June 2023. This study will inform future intervention strategies that promote physical activity and improved diet quality to reduce fatigue in persons with SLE.

User-centered development of a smartphone application (Fit2Thrive) to promote physical activity in breast cancer survivors.

Increased moderate and vigorous physical activity (MVPA) is associated with better health outcomes in breast cancer survivors; yet, most are insufficiently active. Smartphone applications (apps) to promote MVPA have high scalability potential, but few evidence-based apps exist. The purpose is to describe the testing and usability of Fit2Thrive, a MVPA promotion app for breast cancer survivors. A user-centered, iterative design process was utilized on three independent groups of participants. Two groups of breast cancer survivors (group 1 n = 8; group 2: n = 14) performed app usability field testing by interacting with the app for ≥3 days in a free-living environment. App refinements occurred following each field test. The Post-Study System Usability Questionnaire (PSSUQ) and the User Version Mobile Application Rating Scale (uMARS) assessed app usability and quality on a 7- and 5-point scale, respectively, and women provided qualitative written feedback. A third group (n = 15) rated potential app notification content. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed using a directed content analysis. The PSSUQ app usability score (M1= 3.8; SD = 1.4 vs. M2= 3.2; SD = 1.1; lower scores are better) and uMARS app quality score (M1 = 3.4; SD = 1.3 vs. M2= 3.4; SD = 0.6; higher scores are better) appeared to improve in Field Test 2. Group 1 participants identified app "clunkiness," whereas group 2 participants identified issues with error messaging/functionality. Group 3 "liked" 53% of the self-monitoring, 71% of the entry reminder, 60% of the motivational, and 70% of the goal accomplishment notifications. Breast cancer survivors indicated that the Fit2Thrive app was acceptable and participants were able to use the app. Future work will test the efficacy of this app to increase MVPA.

Optimization of a technology-supported physical activity promotion intervention for breast cancer survivors: Results from Fit2Thrive.

BACKGROUND: The benefits of moderate to vigorous physical activity (MVPA) for breast cancer survivors are well established. However, most are insufficiently active. Fit2Thrive used the Multiphase Optimization Strategy methodology to determine the effect of 5 intervention components on MVPA in this population. METHODS: Two hundred sixty-nine participants (mean age, 52.5 years; SD, 9.9 years) received a core intervention (the Fit2Thrive self-monitoring app and Fitbit) and were randomly assigned to 5 intervention components set to on/off in a full factorial experiment: support calls, deluxe app, buddy, online gym, and text messages. The intervention was delivered over 12 weeks with a 12-week follow-up. MVPA was measured via accelerometry at the baseline (T1), at 12 weeks (T2), and at 24 weeks (T3). The main effects and interaction effects at each time point were examined for all components. RESULTS: Trial retention was high: 91.8% had valid accelerometer data at T2 or T3. Across all conditions, there were significant increases in MVPA (+53.6 min/wk; P < .001) and in the proportion of survivors meeting MVPA guidelines (+22.3%; P < .001) at T2 that were maintained but attenuated at T3 (MVPA, +24.6 min/wk; P < .001; meeting guidelines, +12.6%; P < .001). No individual components significantly improved MVPA, although increases were greater for the on level versus the off level for support calls, buddy, and text messages at T2 and T3. CONCLUSIONS: The Fit2Thrive core intervention (the self-monitoring app and Fitbit) is promising for increasing MVPA in breast cancer survivors, but the components provided no additional increases in MVPA. Future research should evaluate the core intervention in a randomized trial and determine what components optimize MVPA behaviors in breast cancer survivors.

Dynamic models of stress-smoking responses based on high-frequency sensor data.

Self-reports indicate that stress increases the risk for smoking; however, intensive data from sensors can provide a more nuanced understanding of stress in the moments leading up to and following smoking events. Identifying personalized dynamical models of stress-smoking responses can improve characterizations of smoking responses following stress, but techniques used to identify these models require intensive longitudinal data. This study leveraged advances in wearable sensing technology and digital markers of stress and smoking to identify person-specific models of stress and smoking system dynamics by considering stress immediately before, during, and after smoking events. Adult smokers (n = 45) wore the AutoSense chestband (respiration-inductive plethysmograph, electrocardiogram, accelerometer) with MotionSense (accelerometers, gyroscopes) on each wrist for three days prior to a quit attempt. The odds of minute-level smoking events were regressed on minute-level stress probabilities to identify person-specific dynamic models of smoking responses to stress. Simulated pulse responses to a continuous stress episode revealed a consistent pattern of increased odds of smoking either shortly after the beginning of the simulated stress episode or with a delay, for all participants. This pattern is followed by a dramatic reduction in the probability of smoking thereafter, for about half of the participants (49%). Sensor-detected stress probabilities indicate a vulnerability for smoking that may be used as a tailoring variable for just-in-time interventions to support quit attempts.

Sense2Stop: A micro-randomized trial using wearable sensors to optimize a just-in-time-adaptive stress management intervention for smoking relapse prevention.

BACKGROUND: Relapse to smoking is commonly triggered by stress, but behavioral interventions have shown only modest efficacy in preventing stress-related relapse. Continuous digital sensing to detect states of smoking risk and intervention receptivity may make it feasible to increase treatment efficacy by adapting intervention timing. OBJECTIVE: Aims are to investigate whether the delivery of a prompt to perform stress management behavior, as compared to no prompt, reduces the likelihood of (a) being stressed and (b) smoking in the subsequent two hours, and (c) whether current stress moderates these effects. STUDY DESIGN: A micro-randomized trial will be implemented with 75 adult smokers who wear Autosense chest and wrist sensors and use the mCerebrum suite of smartphone apps to report and respond to ecological momentary assessment (EMA) questions about smoking and mood for 4 days before and 10 days after a quit attempt and to access a set of stress-management apps. Sensor data will be processed on the smartphone in real time using the cStress algorithm to classify minutes as probably stressed or probably not stressed. Stressed and non-stressed minutes will be micro-randomized to deliver either a prompt to perform a stress management exercise via one of the apps or no prompt (2.5-3 stress management prompts will be delivered daily). Sensor and self-report assessments of stress and smoking will be analyzed to optimize decision rules for a just-in-time adaptive intervention (JITAI) to prevent smoking relapse. SIGNIFICANCE: Sense2Stop will be the first digital trial using wearable sensors and micro-randomization to optimize a just-in-time adaptive stress management intervention for smoking relapse prevention.

Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial.

Importance: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. Objective: To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. Design, Setting, and Participants: Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. Interventions: Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. Main Outcomes and Measures: The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). Results: Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, -6.4 m [95% CI, -21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was -40.9 m (97.5% CI, -61.7 to -20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, -15.1 m [95% CI, -35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, -17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. Conclusions and Relevance: Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD. Trial Registration: ClinicalTrials.gov Identifier: NCT02538900.

A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial.

BACKGROUND: Increased incidence and life expectancy have resulted in a growing population of patients with metastatic breast cancer, and these patients experience high rates of morbidity and premature mortality. Increased physical activity (PA) is consistently associated with improved health and disease outcomes among early-stage survivors. However, there is a paucity of research on PA in patients with metastatic breast cancer, and existing PA interventions have exhibited low feasibility because of their focus on intense PA and/or requirement of on-site visits. Mobile health (mHealth)-based PA interventions may be particularly useful for patients with metastatic breast cancer because they allow for remote monitoring, which facilitates individual tailoring of PA recommendations to patients' abilities and may minimize participant burden. However, no studies have examined mHealth PA interventions in patients with metastatic breast cancer. OBJECTIVE: We aim to address these critical research gaps by testing a highly tailored technology-based intervention to promote PA of any intensity (ie, light, moderate, or vigorous) by increasing daily steps in patients with metastatic breast cancer. The primary aim of this study is to test the feasibility and acceptability of the Fit2ThriveMB intervention. We will also examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom burden, quality of life, and functional performance. METHODS: The Fit2ThriveMB trial is a two-arm pilot randomized controlled trial that will compare the effects of a smartphone-delivered, home-based PA intervention and an attention-control education condition on PA and quality of life in low-active female patients with metastatic breast cancer. A subsample (n=25) will also complete functional performance measures. This innovative trial will recruit 50 participants who will be randomized into the study's intervention or control arm. The intervention will last 12 weeks. The Fit2ThriveMB intervention consists of a Fitbit, coaching calls, and the Fit2ThriveMB smartphone app that provides self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app notifications, and a group message board. Assessments will occur at baseline and post intervention. RESULTS: The Fit2ThriveMB study is ongoing. Data collection ended in February 2021. CONCLUSIONS: Data from this study will provide the preliminary effect sizes needed to assemble an intervention that is to be evaluated in a fully powered trial. In addition, these data will provide essential evidence to support the feasibility and acceptability of using a technology-based PA promotion intervention, a scalable strategy that could be easily integrated into care, among patients with metastatic breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT04129346; https://clinicaltrials.gov/ct2/show/NCT04129346. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24254.