Dataset Information

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial.

ABSTRACT: BACKGROUND:About 5% of breast cancer cases are metastatic at diagnosis, and 20%-30% of localized breast cancer cases become secondarily metastatic. Patients frequently report many detrimental symptoms related to metastasis and treatments. The physical, biological, psychological, and clinical benefits of physical activity during treatment in patients with localized breast cancer have been demonstrated; however, limited literature exists regarding physical activity and physical activity behavior change in patients with metastatic breast cancer. OBJECTIVE:The primary objective of this study is to assess the feasibility of a 6-month physical activity intervention with activity trackers in patients with metastatic breast cancer (the Advanced stage Breast cancer and Lifestyle Exercise, ABLE Trial). Secondary objectives are to examine the effects of physical activity on physical, psychological, anthropometrics, clinical, and biological parameters. METHODS:We plan to conduct a single-center, single-arm trial with 60 patients who are newly diagnosed with metastatic breast cancer. Patients will receive an unsupervised and personalized 6-month physical activity program that includes an activity tracker Nokia Go and is based on the physical activity recommendation. Patients will be encouraged to accumulate at least 150 minutes per week of moderate-to-vigorous intensity physical activity. Baseline and 6-month assessments will include anthropometric measures, functional tests (eg, 6-minute walk test and upper and lower limb strength), blood draws, patient-reported surveys (eg, quality of life and fatigue), and clinical markers of tumor progression (eg, Response Evaluation Criteria In Solid Tumors criteria). RESULTS:Data collection occurred between October 2016 and January 2018, and the results are expected in August 2018. CONCLUSIONS:The ABLE Trial will be the first study to assess the feasibility and effectiveness of an unsupervised and personalized physical activity intervention performed under real-life conditions with activity trackers in patients with metastatic breast cancer. TRIAL REGISTRATION:ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 (Accessed by WebCite at http://www.webcitation.org/71yabi0la). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10487.

SUBMITTER: Delrieu L

PROVIDER: S-EPMC6137283 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial.

Delrieu Lidia L Pérol Olivia O Fervers Béatrice B Friedenreich Christine C Vallance Jeff J Febvey-Combes Olivia O Pérol David D Canada Brice B Roitmann Eva E Dufresne Armelle A Bachelot Thomas T Heudel Pierre-Etienne PE Heudel Pierre-Etienne PE Trédan Olivier O Touillaud Marina M Pialoux Vincent V

JMIR research protocols 20180830 8

<h4>Background</h4>About 5% of breast cancer cases are metastatic at diagnosis, and 20%-30% of localized breast cancer cases become secondarily metastatic. Patients frequently report many detrimental symptoms related to metastasis and treatments. The physical, biological, psychological, and clinical benefits of physical activity during treatment in patients with localized breast cancer have been demonstrated; however, limited literature exists regarding physical activity and physical activity be ...[more]

PMID: 30166274

Similar Datasets

Project description:BackgroundLong-term maintenance of preventive activities is fundamental for achieving improved outcomes in cardiac rehabilitation (CR). Despite this, it has been shown to be a major challenge for many patients to follow recommendations and thereby adhere to a heart-healthy lifestyle. Mobile phone apps have been emphasized as potential tools to promote preventive activities after attendance in a CR program. Before commencing a trial to assess the potential effect of using an app to promote long-term adherence to preventive activities after attendance in CR, a study to assess if it is feasible to use an app is warranted.ObjectiveThe goal of the research is to assess if it is feasible to use a mobile phone app for promoting and monitoring patients' adherence to a heart-healthy lifestyle after CR.MethodsThe study included an experimental, pre-post single-arm trial lasting for 12 weeks. All patients received access to an app aimed to guide individuals to change or maintain a heart-healthy lifestyle. During the study period, patients received weekly, individualized monitoring through the app, based on their own goals. Feasibility outcomes assessed were recruitment rate, adherence to the app, resource requirements, and efficacy regarding capability to detect a change in quality of life, health status, and perceived goal achievement as well as evaluating ceiling and floor effect in these outcomes. Criteria for success were preset to be able to evaluate whether the app was feasible to use in a potential future RCT.ResultsIn total, 71% (17/24) of the patients who completed CR were eligible for a potential RCT as well as for this study. All 14 patients included in the study used the app to promote preventive activities throughout the study. Satisfaction with the technology was high, and the patients found the technology-based follow-up intervention both useful and motivational. Ceiling effect was present in more than 20% of the patients in several domains of the questionnaires evaluating quality of life (36-Item Short Form Health Survey and COOP/WONCA functional health assessments) and health status (EQ-5D). Overall self-rated health status (EuroQol Visual Analog Scale) and perceived goal achievement were found to be outcomes able to detect a change.ConclusionsIndividual follow-up through an app after attendance in CR is feasible. All patients used the app for preventive activities and found the app both useful and motivating. Several points of guidance from the patients in the study have been adopted and incorporated into the final design of the RCT now in the field.

Project description:BACKGROUND:Growing evidence shows that fixed, nonpersonalized daily step goals can discourage individuals, resulting in unchanged or even reduced physical activity. OBJECTIVE:The aim of this randomized controlled trial (RCT) was to evaluate the efficacy of an automated mobile phone-based personalized and adaptive goal-setting intervention using machine learning as compared with an active control with steady daily step goals of 10,000. METHODS:In this 10-week RCT, 64 participants were recruited via email announcements and were required to attend an initial in-person session. The participants were randomized into either the intervention or active control group with a one-to-one ratio after a run-in period for data collection. A study-developed mobile phone app (which delivers daily step goals using push notifications and allows real-time physical activity monitoring) was installed on each participant's mobile phone, and participants were asked to keep their phone in a pocket throughout the entire day. Through the app, the intervention group received fully automated adaptively personalized daily step goals, and the control group received constant step goals of 10,000 steps per day. Daily step count was objectively measured by the study-developed mobile phone app. RESULTS:The mean (SD) age of participants was 41.1 (11.3) years, and 83% (53/64) of participants were female. The baseline demographics between the 2 groups were similar (P>.05). Participants in the intervention group (n=34) had a decrease in mean (SD) daily step count of 390 (490) steps between run-in and 10 weeks, compared with a decrease of 1350 (420) steps among control participants (n=30; P=.03). The net difference in daily steps between the groups was 960 steps (95% CI 90-1830 steps). Both groups had a decrease in daily step count between run-in and 10 weeks because interventions were also provided during run-in and no natural baseline was collected. CONCLUSIONS:The results showed the short-term efficacy of this intervention, which should be formally evaluated in a full-scale RCT with a longer follow-up period. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02886871; https://clinicaltrials.gov/ct2/show/NCT02886871 (Archived by WebCite at http://www.webcitation.org/6wM1Be1Ng).

Project description:BACKGROUND: The use of mobile phones, and specifically smartphones, in the last decade has become more and more prevalent. The latest mobile phones are equipped with comprehensive features that can be used in health care, such as providing rapid access to up-to-date evidence-based information, provision of instant communications, and improvements in organization. The estimated number of health care apps for mobile phones is increasing tremendously, but previous research has highlighted the lack of critical appraisal of new apps. This lack of appraisal of apps has largely been due to the lack of clinicians with technical knowledge of how to create an evidence-based app. OBJECTIVE: We discuss two freely available methodologies for developing Web-based mobile phone apps: a website builder and an app builder. With these, users can program not just a Web-based app, but also integrate multimedia features within their app, without needing to know any programming language. METHODS: We present techniques for creating a mobile Web-based app using two well-established online mobile app websites. We illustrate how to integrate text-based content within the app, as well as integration of interactive videos and rich site summary (RSS) feed information. We will also briefly discuss how to integrate a simple questionnaire survey into the mobile-based app. A questionnaire survey was administered to students to collate their perceptions towards the app. RESULTS: These two methodologies for developing apps have been used to convert an online electronic psychiatry textbook into two Web-based mobile phone apps for medical students rotating through psychiatry in Singapore. Since the inception of our mobile Web-based app, a total of 21,991 unique users have used the mobile app and online portal provided by WordPress, and another 717 users have accessed the app via a Web-based link. The user perspective survey results (n=185) showed that a high proportion of students valued the textbook and objective structured clinical examination videos featured in the app. A high proportion of students concurred that a self-designed mobile phone app would be helpful for psychiatry education. CONCLUSIONS: These methodologies can enable busy clinicians to develop simple mobile Web-based apps for academic, educational, and research purposes, without any prior knowledge of programming. This will be beneficial for both clinicians and users at large, as there will then be more evidence-based mobile phone apps, or at least apps that have been appraised by a clinician.

Project description:BackgroundAlthough mobile health application (mHealth app) programs have effectively promoted disease self-management behaviors in the last decade, usage rates have tended to fall over time.ObjectiveWe used a case management approach led by a nurse and supported by a health-social partnership team with the aim of sustaining app usage among community-dwelling older adults and evaluated the outcome differences (i.e, self-efficacy, levels of depression, and total health service usages) between those who continued to use the app.MethodsThis was a 3-arm randomized controlled trial. A total of 221 older adults with hypertension, diabetes, or chronic pain were randomized into 3 groups: mHealth (n=71), mHealth with interactivity (mHealth+I; n=74), and the control (n=76). The mHealth application was given to the mHealth and mHealth+I groups. The mHealth+I group also received 8 proactive calls in 3 months from a nurse to encourage use of the app. The control group received no interventions. Data were collected at preintervention (T1), postintervention (T2), and at 3 months' postintervention (T3) to ascertain the sustained effect.ResultsA total of 37.8% of mHealth+I and 18.3% of mHealth group participants continued using the mHealth app at least twice per week until the end of the sixth month. The difference in app usage across the 2 groups between T2 and T3 was significant (χ21=6.81, P=.009). Improvements in self-efficacy (β=4.30, 95% CI 0.25-8.35, P=.04) and depression levels (β=-1.98, 95% CI -3.78 to -0.19, P=.03) from T1 to T3 were observed in the mHealth group participants who continued using the app. Although self-efficacy and depression scores improved from T1 to T2 in the mHealth+I group, the mean values decreased at T3. Health service usage decreased for all groups from T1 to T2 (β=-1.38, 95% CI -1.98 to -0.78, P<.001), with a marginal increase at T3.ConclusionsThe relatively low rates of mHealth app usage at follow-up are comparable to those reported in the literature. More work is needed to merge the technology-driven and in-person aspects of mHealth.Trial registrationClinicalTrials.gov NCT03878212; https://clinicaltrials.gov/ct2/show/NCT03878212.International registered report identifier (irrid)RR2-10.1159/000509129.

Project description:BackgroundSingapore's current prevalence of diabetes exceeds 13.6%. Although lifestyle modification can be effective for reducing the risks for complications of type 2 diabetes mellitus (T2DM), traditional lifestyle interventions are often difficult to administer in the primary care setting due to limited resources. Mobile health apps can address these limitations by offering low-cost, adaptable, and accessible platforms for disseminating lifestyle management interventions.ObjectiveUsing the RE-AIM evaluation framework, this study assessed the potential effectiveness and feasibility of GlycoLeap, a mobile lifestyle management program for people with T2DM, as an add-on to standard care.MethodsThis single-arm feasibility study recruited 100 patients with T2DM and glycated hemoglobin (HbA1c) levels of ≥7.5% from a single community health care facility in Singapore. All participants were given access to a 6-month mobile lifestyle management program, GlycoLeap, comprising online lessons and the Glyco mobile phone app with a health coaching feature. The GlycoLeap program was evaluated using 4 relevant dimensions of the RE-AIM framework: (1) reach (percentage who consented to participate out of all patients approached), (2) effectiveness (percentage point change in HbA1c [primary outcome] and weight loss [secondary outcome]), (3) implementation (program engagement as assessed by various participatory metrics), and (4) maintenance (postintervention user satisfaction surveys to predict the sustainability of GlycoLeap). Participants were assessed at baseline and at follow-up (≥12 weeks after starting the intervention).ResultsA total of 785 patients were approached of whom 104 consented to participate, placing the reach at 13.2%. Four were excluded after eligibility screening, and 100 patients were recruited. Program engagement (implementation) started out high but decreased with time for all evaluated components. Self-reported survey data suggest that participants monitored their blood glucose on more days in the past week at follow-up compared to baseline (P<.001) and reported positive changes to their diet due to app engagement (P<.001) (implementation). Primary outcome data were available for 83 participants. Statistically significant improvements were observed for HbA1c (-1.3 percentage points, P<.001) with greater improvements for those who logged their weight more often (P=.007) (effectiveness). Participants also had a 2.3% reduction in baseline weight (P<.001) (effectiveness). User satisfaction was high with 74% (59/80) and 79% (63/80) of participants rating the app good or very good and claiming that they would probably or definitely recommend the app to others, respectively (maintenance).ConclusionsAlthough measures of program engagement decreased with time, clinically significant improvements in HbA1c were achieved with the potential for broader implementation. However, we cannot rule out that these improvements were due to factors unrelated to GlycoLeap. Therefore, we would recommend evaluating the effectiveness and cost effectiveness of GlycoLeap using a randomized controlled trial of at least 12 months.Trial registrationClinicalTrials.gov NCT03091517; https://clinicaltrials.gov/ct2/show/NCT03091517 (Archived by WebCite at http://www.webcitation.org/77rNqhwRn).

Project description:BackgroundOrthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual's capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual's capability, opportunity, and motivation.ObjectiveThis study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial.MethodsThis study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app.ResultsThis study was approved by the London - Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020.ConclusionsGiven the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity.Trial registrationClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739.International registered report identifier (irrid)PRR1-10.2196/18021.

Project description:BACKGROUND:Improving the quality of patient care through the use of mobile devices is one of the hot topics in the health care field. In unwanted situations like an accident, ambulances and rescuers often require a certain amount of time to arrive at the scene. Providing immediate cardiopulmonary resuscitation (CPR) to patients might improve survival. OBJECTIVE:The primary objective of this study was to evaluate the feasibility of an emergency and mutual-aid app model in Taiwan and to provide a reference for government policy. METHODS:A structured questionnaire was developed as a research tool. All questionnaires were designed according to the technology acceptance model, and a Likert scale was used to measure the degree of agreement or disagreement. Moreover, in-depth interviews were conducted with six experts from medical, legal, and mobile app departments. Each expert was interviewed once to discuss feasible countermeasures and suggestions. Statistical Package for the Social Sciences (SPSS version 19; IBM Corp, Armonk, New York) was used to perform all statistical analyses, including descriptive statistics, independent sample t-tests, variance analysis, and Pearson correlation analysis. RESULTS:We conducted this study between October 20, 2017, and November 10, 2017, at the Taipei Medical University Hospital. Questionnaires were distributed to medical personnel, visiting guests, family members, and volunteers. A total of 113 valid questionnaires were finally obtained after the exclusion of incomplete questionnaires. Cronbach ? values for self-efficacy (perceived ease of use), use attitude (perceived usefulness), and use willingness and frequency were above .85, meeting the criterion of greater than .70. We observed that the reliability of each subquestion was acceptable and the values for use attitude (perceive usefulness) and use willingness and frequency were more than .90. CONCLUSIONS:The findings suggest that perceived ease of use and perceived usefulness of the app model affect use willingness. However, perceived usefulness had an intermediary influence on use willingness. Experts in law, medical, and technology fields consider that an emergency and mutual-aid model can be implemented in Taiwan. Along with the development of an emergency and mutual-aid app model, we recommend an increase in the number of automated external defibrillators per region and promotion of correct knowledge about CPR in order to decrease morbidity and mortality.

Dataset Information

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial.

Publications

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets