Self-monitoring physical activity with a smartphone application in cancer patients: a randomized feasibility study (SMART-trial).
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ABSTRACT: Purpose
Evidence accumulates that an active lifestyle positively influences cancer treatment outcome. A "smartphone application" (app) such as "RunKeeper," to self-monitor physical activity (PA) might be helpful. This study aimed to examine whether using RunKeeper to increase self-reported PA is feasible in cancer patients and to evaluate patients' opinion about using RunKeeper in a 12-week program.Methods
Adult patients (n =?32), diagnosed with cancer, were randomized between usual care (n =?16) or a 12-week intervention with instructions to self-monitor PA with RunKeeper (n =?16). Changes in PA were determined with the Physical Activity Scale for the Elderly (PASE) at baseline (T0), 6 weeks (T1), and 12 weeks (T2). Usability and patients' experiences were tested at T2 with the System Usability Scale (SUS) and a semi-structured interview.Results
Patient mean age was 33.6 years. Between T0 and T1, an increase in PA of 51% (medium estimated effect size r =?0.40) was found in PASE sum score in the intervention group compared with usual care. In addition, total minutes of PA increased with 46% (r =?0.37). These effects decreased over time (T2). Sedentary time decreased with 19% between T0 and T1 and 27% between T0 and T2. Usability was rated "good" and most patients found RunKeeper use helpful to improve PA.Conclusions
Self-monitoring PA with RunKeeper was safe and feasible in cancer patients. The RunKeeper use resulted in an increase in PA after 6 weeks. RunKeeper usability was rated good and can be used to study PA in cancer patients.Trial registration
NCT02391454.
SUBMITTER: Ormel HL
PROVIDER: S-EPMC6182373 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
Publications
Self-monitoring physical activity with a smartphone application in cancer patients: a randomized feasibility study (SMART-trial).
Ormel Harm L HL van der Schoot Gabriela G F GGF Westerink Nico-Derk L NL Sluiter Wim J WJ Gietema Jourik A JA Walenkamp Annemiek M E AME
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20180521 11
<h4>Purpose</h4>Evidence accumulates that an active lifestyle positively influences cancer treatment outcome. A "smartphone application" (app) such as "RunKeeper," to self-monitor physical activity (PA) might be helpful. This study aimed to examine whether using RunKeeper to increase self-reported PA is feasible in cancer patients and to evaluate patients' opinion about using RunKeeper in a 12-week program.<h4>Methods</h4>Adult patients (n = 32), diagnosed with cancer, were randomized between us ...[more]
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Project description:BackgroundThe sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity.ObjectiveWe aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants' perception regarding the protocol and the use of the app for physical activity qualitatively.MethodsWe conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention.ResultsTwelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median -198 steps/day [IQR -279 to -103] to 20 steps/day [IQR -204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants' reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals.ConclusionsThe SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones.Trial registrationBrazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.
| S-EPMC7647811 | biostudies-literature
Project description:BackgroundOver 1.3 million people live with colorectal cancer in the United States. Physical activity is associated with lower risk of colorectal cancer recurrence and mortality. Interventions are needed to increase physical activity in colorectal cancer survivors.MethodsWe conducted a 2-arm non-blinded pilot randomized controlled trial at the University of California, San Francisco among 42 individuals who had completed curative-intent treatment for colorectal cancer to determine the feasibility and acceptability of a 12-week (84 days) physical activity intervention using a Fitbit Flex™ and daily text messages. Participants were randomized 1:1 to receive the intervention with print educational materials or print educational materials alone. We explored the impact of the intervention versus usual care on physical activity using ActiGraph GT3X+ accelerometers pre-/post-intervention.ResultsWe screened 406 individuals and randomized 42 to intervention (n = 21) or control (n = 21) groups. During the 12-week study, the intervention arm wore their Fitbits a median of 74 days [88% of days in study period, interquartile range: 23-83 days] and responded to a median of 34 (out of 46) text messages that asked for a reply (interquartile range: 13-38 text messages). Among the 16 intervention participants who completed the feedback survey, the majority (88%) reported that the intervention motivated them to exercise and that they were satisfied with their experience. No statistically significant difference in change in moderate-to-vigorous physical activity was found from baseline to 12 weeks between arms.ConclusionA 12-week physical activity intervention with a Fitbit and text messages was feasible and acceptable among colorectal cancer patients after curative treatment. Larger studies are needed to determine whether the intervention increases physical activity.Trial registrationClinicaltrials.gov Identifier NCT02966054 . Registered 17 November 2016, retrospectively registered.
| S-EPMC6417122 | biostudies-literature
Project description:Integral components of behavioral weight-loss treatment include self-monitoring of diet and physical activity along with feedback to participants regarding their behaviors. While providing feedback has been associated with weight loss, no studies have examined the impact of feedback frequency on weight loss or the mediating role of self-monitoring adherence in this relationship.This study examined the effect of participant feedback frequency on weight loss and determined if this effect was mediated by adherence to self-monitoring in a behavioral weight-loss trial conducted in the USA.Participants (N?=?210) were randomly assigned to one of three self-monitoring methods with either no-daily feedback messages or daily feedback messages: (1) paper diary (PD), no-daily feedback; (2) personal digital assistant (PDA), no-daily feedback; and (3) PDA, daily tailored feedback messages (PDA + FB). The Sobel test via bootstrapping examined the direct effect of feedback frequency on weight loss and the indirect effect through self-monitoring adherence.Receiving daily feedback messages significantly increased participants' self-monitoring adherence. A significant effect of feedback frequency on weight loss was noted; however, after adjusting for self-monitoring adherence, the effect of feedback frequency on weight loss was no longer significant. Feedback frequency had a significant indirect effect on weight loss through self-monitoring adherence.Self-monitoring adherence mediated the effect of feedback frequency on weight loss. Increasing the frequency with which participants receive feedback could enhance self-monitoring adherence, a critical component of behavioral weight-loss treatment.
| S-EPMC3529986 | biostudies-literature
Project description:BACKGROUND:Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE:This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS:GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ?800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS:At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS:Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. TRIAL REGISTRATION:ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).
| S-EPMC6416539 | biostudies-literature
Project description:BackgroundObesity is a common global health problem and increases the risk of many chronic illnesses. Given the adverse effects of antiobesity agents and bariatric surgeries, the exploration of noninvasive and nonpharmacological complementary methods for weight reduction is warranted.ObjectiveThe study aimed to determine whether self-administered auricular acupressure (AA) integrated with a smartphone app was more effective than using AA alone or the controls for weight reduction.MethodsThis study is a 3-arm randomized waitlist-controlled feasibility trial. A total of 59 eligible participants were randomly divided into either group 1 (AA group, n=19), group 2 (AA plus smartphone app, n=19), or group 3 (waitlist control, n=21). A total of 6 reflective zones or acupoints for weight reduction were chosen. The smartphone app could send out daily messages to the subjects to remind them to perform self-pressing on the 6 ear acupoints. A "date picker" of the 8-week treatment course was used to enable the users to input the compliance of pressing and the number of bowel movement daily instead of using the booklet for recordings. The app also served as a reminder for the subjects regarding the dates for returning to the center for acupoint changing and assessments. Treatment was delivered 2 times a week, for 8 weeks. Generalized estimating equations were used to examine the interactions among the groups before and after intervention.ResultsSubjects in group 2 expressed that the smartphone app was useful (7.41 out of 10). The most popular features were the daily reminders for performing self-pressing (88%), the ear diagram indicating the locations and functions of the 6 ear points (71%), and ear pressing method demonstrated in the video scripts (47%). Nearly 90% of the participants completed the 8-week intervention, with a high satisfaction toward the overall arrangement (8.37 out of 10). The subjects in group 1 and 2 achieved better therapeutic effects in terms of body weight, body mass index (BMI), waist circumference, and hip circumference and perceived more fullness before meals than the waitlist controls. Although no significant differences in the pairwise comparisons between the 2 groups were detected (P>.05), the decrease in body weight, BMI, body fat, visceral fat rating and leptin level, and increase in adiponectin level were notable in group 2 before and after the intervention.ConclusionsThe high compliance rate and high satisfaction toward the trial arrangement indicate that AA can be used to achieve weight reduction and applied in future large-scale studies. AA integrated with the smartphone app has a more notable effect than using AA alone for weight reduction. Larger sample size should be considered in future trials to determine the causal relationship between treatment and effect.Trial registrationClinicalTrials.gov NCT03442712; https://clinicaltrials.gov/ct2/show/NCT03442712 (Archived by WebCite at http://www.webcitation.org/78L2tO8Ql).
| S-EPMC6658225 | biostudies-literature
Project description:BackgroundPeople with chronic progressive multiple sclerosis (CPMS) have limited options in medical treatment. Enhancing physical activity (PA) might promote neuroregeneration in multiple sclerosis (MS) and positively influence disability, thus providing an alternative to medical treatment. Previous studies indicate that evidence-based patient information (EBPI) is essential for inducing behavioral change, e.g. enhancing PA.ObjectiveTo investigate feasibility of a smartphone app providing EBPI about the benefit of PA and a simple activity feedback to enhance PA in people with CPMS in a pilot randomized controlled trial over 3 months.MethodsThirty-eight people with CPMS (mean age 51 years, median Expanded Disability Status Scale 4.0) were 1:1 randomized into either a control group (n = 20) or an intervention group (n = 18). The intervention group received access to a multimedia EBPI app including activity feedback, texts, figures and videos. In the control group, participants received a leaflet with unspecific information about exercising in general. The EPBI itself was designed based on a systematic review. At baseline and after 3 months, all participants underwent clinical performance tests, filled in questionnaires and received an activity monitor (Actigraph®) for 7 days. The primary endpoint was the rate of responders defined as participants with a 20% increase of physical acitivity (time of moderate or vigiorous PA-MVPA) or 20% increase of the number of steps, both assessed with the activity monitor. As secondary endpoints, we compared accelerometry, performance and questionnaires adjusted for baseline measurments between the groups (ANCOVA). Moreover, we used questionnaires to compare knowledge about exercise (activity requiring physical effort, carried out to improve or improve health and fitness) in MS, usability of the app in general and motivation towards a more active lifestyle after 3 months in both groups.ResultsThe groups showed significant differences in disease duration and PA according to the Godin-Leisure Time Exercise Questionnaire at baseline. After 3 months, we detected no difference in the rate of responders, which was an overall 22%. However, MVPA significantly increased in both groups (p < 0.001) and the intervention group tended to have a higher motivation towards a more active lifestyle (Cohens D = 0.7, p = 0.09) as measured by the questionnaire. Reponses also showed, that participants appreciated the app but claimed a lack of interactivity as a short-coming.ConclusionJust providing information in a multimedia smartphone app did not enhance physical activitiy more than a simple leaflet in this small pilot trial in CPMS. However, the group of app users tended to have a higher motivation towards a more active lifestyle. Overall, the concept of a smartphone app to support an active lifestyle in MS is highly appreciated by participants.
| S-EPMC7319035 | biostudies-literature
Project description:BACKGROUND:Severe obesity among youths (BMI for age≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment. OBJECTIVE:This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program. METHODS:Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points. RESULTS:This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021. CONCLUSIONS:The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/18098.
| S-EPMC7305562 | biostudies-literature
Project description:BackgroundRegular aerobic physical activity (PA) is an important component of healthy aging. However, only 27%-40% of African American women achieve national PA guidelines. Available data also show a clear decline in PA as African American women transition from young adulthood (ie, 25-44 years) into midlife. This decline in PA during midlife coincides with an increased risk for African American women developing cardiometabolic disease conditions, including obesity, type 2 diabetes, and cardiovascular disease. Thus, effective efforts are needed to promote PA among sedentary African American women during midlife.ObjectiveThis study aims to examine the acceptability and feasibility of a culturally tailored, smartphone-delivered PA intervention, originally developed to increase PA among African American women aged 24-49 years, among a slightly older sample of midlife African American women aged 50-65 years.MethodsA single-arm pretest-posttest study design was implemented. In total, 20 insufficiently active African American (ie, ≤60 min per week of PA) women between the ages of 50-65 years participated in the 4-month feasibility trial. The Smart Walk intervention was delivered through the study Smart Walk smartphone app and text messages. Features available on the Smart Walk app include personal profile pages, multimedia PA promotion modules, discussion board forums, and an activity tracking feature that integrates with Fitbit activity monitors. Self-reported PA and social cognitive theory mediators targeted by the intervention (ie, self-regulation, behavioral capability, outcome expectations, self-efficacy, and social support) were assessed at baseline and at 4 months. Feasibility and acceptability were assessed using a postintervention satisfaction survey that included multiple-choice and open-ended questions evaluating participant perceptions of the intervention and suggestions for intervention improvement. Wilcoxon signed-rank tests were used to examine pre- and postintervention changes in the PA and social cognitive theory variables. The effect size estimates were calculated using the Pearson r test statistic.ResultsParticipants increased moderate-to-vigorous PA (median 30 minutes per week increase; r=0.503; P=.002) and reported improvements in 2 theoretical mediators (self-regulation: r=0.397; P=.01; behavioral capability: r=0.440; P=.006). Nearly all participants (14/15, 93% completing the satisfaction survey) indicated that they would recommend the intervention to a friend. Participants' suggestions for improving the intervention included enhancing the intervention's provisions of social support for PA.ConclusionsThe results provide preliminary support for the feasibility of the smartphone-based approach to increase PA among midlife African American women. However, before larger-scale implementation among midlife African American women, enhancements to the social support components of the intervention are warranted.Trial registrationClinicalTrials.gov NCT04073355; https://clinicaltrials.gov/ct2/show/NCT04073355.
| S-EPMC8103296 | biostudies-literature
Project description:ImportanceMelanoma is among the most lethal skin cancers; it has become the fifth most common cancer in the United Kingdom, and incidence rates are rising. Population approaches to reducing incidence have focused on mass media campaigns to promote earlier presentation and potentially improve melanoma outcomes; however, interventions using smartphone applications targeting those with the greatest risk could promote earlier presentation to health care professionals for individuals with new or changing skin lesions.ObjectiveTo study the effect of a commercially available skin self-monitoring (SSM) smartphone application among individuals with increased risk of melanoma on their decision to seek help for changing skin lesions.Design, setting, and participantsThis phase 2 randomized clinical trial was conducted in 12 family practices in Eastern England between 2016 and 2017. A total of 238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms. Analysis was intention to treat. Participants were observed for 12 months, and data analysis was conducted from January to August 2018.InterventionThe intervention and control groups received a consultation with standard written advice on sun protection and skin cancer detection. The intervention group had an SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders.Main outcomes and measuresThe coprimary outcomes were skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician. Follow-up questionnaires were sent at 6 and 12 months, and consultation rates were extracted from family practice records. Secondary outcomes included skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms.ResultsA total of 238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0%] randomized to the intervention group). Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire. There were no significant differences in skin consultation rates (adjusted risk ratio, 0.96; 95% CI, 0.56 to 1.66; P?=?.89), measures of SSM (adjusted mean difference, 0.08; 95% CI, -0.83 to 1.00; P?=?.86), or psychological harm (eg, Melanoma Worry Scale: adjusted mean difference, -0.12; 95% CI, -0.56 to 0.31; P?=?.58).Conclusions and relevanceIn this study, recruitment, retention, and initial delivery of the intervention were feasible, and this research provided no evidence of harm from the SSM smartphone application. However, no evidence of benefit on skin self-examination or health care consulting was found, and there is no reason at this stage to recommend its implementation in this population at increased risk of melanoma.Trial registrationisrctn.org Identifier: ISRCTN16061621.
| S-EPMC7137684 | biostudies-literature
Project description:BACKGROUND:Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease. OBJECTIVE:The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA. METHODS:This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app. RESULTS:Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021. CONCLUSIONS:The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care. TRIAL REGISTRATION:Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15105.
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