Protocol for a pilot randomized controlled trial of a mobile health exercise intervention for older patients with myeloid neoplasms (GO-EXCAP 2).
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ABSTRACT: Introduction
We have shown the Exercise for Cancer Patients (EXCAP©®) exercise program improved physical function and symptoms and reduced inflammatory markers in patients with cancer. However, adherence to exercise was lower in older adults compared to their younger counterparts. We then leveraged a mobile app to deliver EXCAP©® and adapted the intervention [Geriatric-Oncology (GO)-EXCAP] for older patients with myeloid neoplasms. In this pilot randomized trial, the primary goal is to determine effect sizes. We propose to assess the preliminary efficacy of GO-EXCAP compared to a behavioral placebo control on physical function, patient-reported outcomes (fatigue, mood, and quality of life), and inflammatory markers in 100 patients aged ≥60 years with myeloid neoplasms receiving outpatient chemotherapy.Methods
GO-EXCAP consists of the EXCAP©® exercise prescription (daily home-based progressive aerobic walking and resistance exercises with rated perceived exercise of 5-8), EXCAP©® kit (i.e., activity tracker, resistance bands, print manual, bag), a mobile app, and an in-person or virtual session with the exercise physiologist to deliver exercise prescription. The intervention will last for three cycles of chemotherapy (approximately 12 weeks). The primary outcome measure will be physical function (Short Physical Performance Battery). Secondary outcome measures include fatigue (Brief Fatigue Inventory), mood (Center for Epidemiologic Studies Depression Scale), and quality of life (Functional Assessment of Cancer Therapy-Leukemia). Exploratory outcome measures include inflammatory markers.Discussion
Older adults with myeloid neoplasms receiving outpatient chemotherapy serve as an ideal model for studying an individually tailored mobile health exercise intervention in vulnerable older patients receiving cancer treatments to prevent physical function decline and improve symptoms.
SUBMITTER: Loh KP
PROVIDER: S-EPMC9058183 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
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Protocol for a pilot randomized controlled trial of a mobile health exercise intervention for older patients with myeloid neoplasms (GO-EXCAP 2).
Loh Kah Poh KP Sanapala Chandrika C Janelsins Michelle M Klepin Heidi D HD Schnall Rebecca R Culakova Eva E Sohn Michael B MB Vertino Paula P Susiarjo Martha M Jensen-Battaglia Marielle M Becker Michael W MW Liesveld Jane J Mendler Jason H JH Huselton Eric E Lin Po-Ju PJ Mustian Karen K
Journal of geriatric oncology 20211221 4
<h4>Introduction</h4>We have shown the Exercise for Cancer Patients (EXCAP<sup>©®</sup>) exercise program improved physical function and symptoms and reduced inflammatory markers in patients with cancer. However, adherence to exercise was lower in older adults compared to their younger counterparts. We then leveraged a mobile app to deliver EXCAP<sup>©®</sup> and adapted the intervention [Geriatric-Oncology (GO)-EXCAP] for older patients with myeloid neoplasms. In this pilot randomized trial, th ...[more]
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Project description:Many older patients with myeloid neoplasms experience treatment-related toxicities. We previously demonstrated that a home-based, progressive aerobic walking and resistance exercise program (EXCAP) improved physical and psychological outcomes in patients with cancer. However, older patients have more difficulty adhering to exercise than younger patients. Reasons may include low motivation, difficulty with transportation, and limited access to exercise professionals. To improve exercise adherence, we integrated a mobile app with EXCAP (GO-EXCAP) and assessed its feasibility and usability in a single-arm pilot study among older patients with myeloid neoplasms undergoing outpatient chemotherapy. GO-EXCAP intervention lasts for 2 cycles of treatment, and the primary feasibility metric was data reporting on the app. Usability was evaluated via the system usability scale (SUS). Patients were interviewed at mid and postintervention to elicit their feedback, and deductive thematic analysis was applied to the transcripts. Twenty-five patients (mean age, 72 years) were recruited. Recruitment and retention rates were 64% and 88%, respectively. Eighty-two percent (18/22) of patients entered some exercise data on the app at least half of the study days, excluding hospitalization (a priori, we considered 70% as feasible). Averaged daily steps were 2848 and 3184 at baseline and after intervention, respectively. Patients also performed resistance exercises 26.2 minutes per day, 2.9 days per week at low intensity (rate of perceived exertion 3.8/10). Usability was above average (SUS, 70.3). In qualitative analyses, 3 themes were identified, including positive experience with the intervention, social interactions, and flexibility. The GO-EXCAP intervention is feasible and usable for older patients with myeloid neoplasms undergoing outpatient chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT04035499.
| S-EPMC9278283 | biostudies-literature
Project description:IntroductionOlder patients with myeloid neoplasms (MN) receiving outpatient chemotherapy are at risk of experiencing treatment-related toxicities such as functional decline. A mobile health (mHealth) exercise intervention may ameliorate these toxicities. This qualitative study aimed to inform the design of a mHealth exercise intervention for this population.MethodsThis was a qualitative study of thirteen patients aged ≥60 years receiving hypomethylating agents for MN. EXCAP©® is a home-based walking and progressive resistance exercise program. We combined EXCAP©® with a mobile app; the combination (GO-EXCAP Mobile App) has not been previously tested. A brief verbal description about the intervention was provided to the participants but they did not perform it. Participants were interviewed and inductive thematic analysis was used to analyze the data.ResultsMean age was 71.6 (SD 8.5). Three themes were identified: 1) Perceptions of the intervention feasibility, 2) Ways to leverage the app to deliver the exercise intervention, and 3) Personalized exercise goals. Walking and resistance exercises were perceived to be feasible. Patients were comfortable initiating the intervention in cycle 2 of chemotherapy, with exercise increments occurring from week 2-4 of the cycle. Ways to leverage the app to deliver EXCAP©® include 1) Video feature for exercise demonstration and interactions, and 2) Exercise data and symptom surveys to be communicated to the exercise physiologist and primary oncology team. Preservation of existing function and activity was an important goal to participants.ConclusionsOur findings provide insights about the preferences of older adults with MN for a mHealth exercise intervention.
| S-EPMC8260435 | biostudies-literature
Project description:PurposeExercise may ameliorate treatment-related symptoms, but older adults have lower exercise adherence compared to their younger counterparts due to treatment-related symptoms.MethodsWe recruited older patients with myeloid neoplasms receiving chemotherapy to a pilot study of a mobile health exercise intervention. Participants entered their steps and resistance data into the app daily, and symptom data twice a week, over an 8-12 week period. In this proof-of-concept analysis, we used a linear mixed-effects model to assess the association of symptoms from the previous week with exercise adherence in the current week among older adults with myeloid neoplasms.ResultsMean age was 74.3 (SD = 5.0) years (N = 7). At baseline, patients on average walked 2564 daily steps (SD = 1816), which increased to 2967 (SD = 3448) post-intervention. Patients on average performed 3.5 (SD = 2.6) days of resistance training weekly, with mean duration of 21.5 min (SD = 11.6) and rated perceived exertion of 3.68 (SD = 1.78) on a 0-10 scale. Lower average steps in the current week was associated with greater interference with daily activities from pain (β = - 203.13, p = 0.05), memory (β = - 492.29, p = 0.09), numbness (β = - 353.57, p = 0.07), and sadness (β = - 403.03, p = 0.09) in the previous week. Similarly, lower average resistance minutes in the current week were associated with greater pain, sadness, and anxiety in the previous week.ConclusionsWe found that greater pain, sadness, and anxiety were associated with lower exercise adherence. Symptom monitoring and management in older adults with myeloid neoplasms receiving chemotherapy can promote exercise adherence and in turn improve symptoms.Trial registrationClinicalTrials.gov Identifier: NCT04035499. Registered 7/29/2019.
| S-EPMC10883479 | biostudies-literature
Project description:BackgroundAdolescence and young adulthood are critical times of initiation and progression to daily use of tobacco. However, it is difficult to recruit young adults to traditional smoking cessation and retention rates are typically low. Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse. Given the popularity of smartphones among young adults and the considerably higher download rates of commercially developed apps compared to research-based apps, there is a need to design pragmatic studies that evaluate commercial tobacco cessation apps. The aims of this pilot study are to assess the impact on tobacco cessation of using a smartphone app compared with usual care and to generate feasibility data to inform a future fully powered clinical trial.MethodsWe will conduct an open randomized controlled trial with parallel groups. Participants will be selected from hospitalized patients and must be aged 18-30 years, interested in cessation, smoked > 5 cigarettes/day over the past 30 days, and own an Apple or Android smartphone. Participants who are eligible will be randomized to either a smartphone experimental group or patient-initiated follow up (usual care). As this study seeks to assess feasibility, the primary data will include (1) recruitment rates, (2) retention rates, and (3) adherence, measured through user engagement with the app.DiscussionThis pilot trial will be the first to evaluate a commercially available smartphone app for tobacco cessation in a hospitalized setting. Data generated by this study can be used for larger fully powered trials such as comparative effectiveness studies against apps developed by academics or health scientists based on behavioral theories, or cost-effectiveness analyses of mobile interventions.Trial registrationClinicalTrials.gov, NCT03538678 . Registered on 28 May 2018.
| S-EPMC6390617 | biostudies-literature
Project description:BackgroundObjective monitoring of self-directed physical activity (PA) is a common approach used in both fitness and health settings to promote exercise behavior, but adherence has been poor. Newer mobile health (mHealth) technologies could be a cost-effective approach to broadening accessibility and providing support for PA behavior change; yet, the optimal method of delivery of such interventions is still unclear.ObjectiveThis study aimed to determine the feasibility and acceptability of an mHealth exercise intervention delivered in combination with objective monitoring in 3 ways: health education emails, asynchronous exercise videos, or synchronous videoconference exercise classes.MethodsPhysically inactive (<30 min/wk) adults (cisgender women aged 31.5, SD 11.3 years, cisgender men aged 34.1, SD 28.9 years, and nonbinary individuals aged 22.0, SD 0 years) were randomized (1:1:1) to 8 weeks of increasing PA behavioral support: level 1 (health education+objective monitoring, n=26), level 2 (asynchronous contact, level 1+prerecorded exercise videos, n=30), or level 3 (synchronous contact, level 1+videoconference group exercise, n=28). Participants used a heart rate monitor during exercise and a mobile app for interaction. Primary outcomes were feasibility (accrual, retention, and adherence) and acceptability (user experience survey). Secondary outcomes assessed at baseline and 8 weeks included resting heart rate, self-reported PA, and quality of life. The exercise dose was evaluated throughout the intervention.ResultsBetween August 2020 and August 2021, 204 adults were screened for eligibility. Out of 135 eligible participants, 84 (62%) enrolled in the study. Retention was 50% (13/26) in level 1, 60% (18/30) in level 2 and 82% (23/28) in level 3, while adherence was 31% (8/26) in level 1, 40% (12/30) in level 2 and 75% (21/28) in level 3. A total of 83% (70/84) of the study sample completed the intervention, but low response rates (64%, 54/84) were observed postintervention at week-8 assessments. Program satisfaction was highest in participants receiving exercise videos (level 2, 80%, 8/10) or exercise classes (level 3, 80%, 12/15), while only 63% (5/8) of level 1 reported the program as enjoyable. Level 3 was most likely to recommend the program (87%, 13/15), compared to 80% (8/10) in level 2 and 46% (5/8) in level 1. Self-reported PA significantly increased from baseline to intervention in level 3 (P<.001) and level 2 (P=.003), with no change in level 1. Level 3 appeared to exercise at higher doses throughout the intervention.ConclusionsOnly the videoconference exercise class intervention met feasibility criteria, although postintervention response rates were low across all groups. Both videoconference and prerecorded videos had good acceptability, while objective monitoring and health education alone were not feasible or acceptable. Future studies are needed to examine the effectiveness of videoconference exercise interventions on health-related outcomes during nonpandemic times and how asynchronous interventions might maximize adherence.Trial registrationClinicalTrials.gov NCT05192421; https://clinicaltrials.gov/study/NCT05192421.
| S-EPMC11346126 | biostudies-literature
Project description:IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men's access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40-69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594-17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.
| S-EPMC7200044 | biostudies-literature
Project description:BackgroundFrailty, a common geriatric syndrome, predisposes older adults to functional decline. No medications can alter frailty's trajectory, but nutritional interventions may aid in supporting independence.ObjectiveThis paper presents a pilot randomized controlled trial to investigate the feasibility and efficacy of a mobile health intervention, "Olitor," designed to enhance adherence to the Mediterranean diet among older adults with frailty, requiring no external assistance.MethodsThe study sample consisted of 15 participants aged 66-77 (mean 70.5, SD 3.96) years randomized into intervention (n=8; 8 females; mean 72.4, SD 4.8 years) and control groups (n=7; 6 females, 1 male; mean 70.0, SD 3.9 years). The intervention involved a patient-facing mobile app called "Olitor" and a secure web-based administrative dashboard. Participants were instructed to use the app at least weekly for 3 months, which provided feedback on their food choices, personalized recipe recommendations, and an in-app messaging feature. Using Mann-Whitney tests to compare change scores and Hedges g statistics to estimate effect sizes, the primary efficacy outcomes were adherence to the Mediterranean diet score and insulin resistance measures. Secondary outcomes included retention as a measure of feasibility, engagement level and user app quality ratings for acceptability, and additional metrics to evaluate efficacy. Models were adjusted for multiple comparisons.ResultsThe findings demonstrated a significant improvement in the Mediterranean diet adherence score in the intervention group compared to the control (W=50.5; adjusted P=.04) with median change scores of 2 (IQR 2-4.25) and 0 (IQR -0.50 to 0.50), respectively. There was a small and insignificant reduction in homeostasis model assessment of insulin resistance measure (W=23; adjusted P=.85). Additionally, there were significant increases in legume intake (W=54; adjusted P<.01). The intervention's effect size was large for several outcomes, such as Mediterranean diet adherence (Hedges g=1.58; 95% CI 0.34-2.67) and vegetable intake (Hedges g=1.14; 95% CI 0.08-2.21). The retention rate was 100%. The app's overall quality rating was favorable with an average interaction time of 12 minutes weekly.ConclusionsThis pilot study revealed the potential of the mobile intervention "Olitor" in promoting healthier eating habits among older adults with frailty. It demonstrated high retention rates, significant improvement in adherence to the Mediterranean diet, and increased intake of recommended foods. Insulin resistance showed a minor nonsignificant improvement. Several secondary outcomes, such as lower extremity function and Mediterranean diet knowledge, had a large effect size. Although the app's behavior change features were similar to those of previous digital interventions, the distinctive focus on theory-informed mechanistic measures involved in behavioral change, such as self-regulation, self-efficacy, and expected negative outcomes, may have enhanced its potential. Further investigations in a more diverse and representative population, focusing on individuals with impaired insulin sensitivity, are warranted to validate these preliminary findings.Trial registrationClinicalTrials.gov NCT05236712; https://clinicaltrials.gov/study/NCT05236712.
| S-EPMC10687683 | biostudies-literature
Project description:Introduction: Previous studies have shown an improvement in the access to treatment for patients with first-episode psychosis (FEP), specifically young patients, through mobile app-based interventions. The aim of this study is to test the effectiveness of a mobile app-based intervention to improve community functioning in adolescents with FEP. Mobile app-based interventions could increase quality of life and disease awareness, which improve adherence to treatment and reduce the frequency of relapses and rehospitalizations in adolescents with FEP. Methods: This article describes a mobile app treatment and the pilot trial protocol for patients with FEP. We will perform a single-blind randomized clinical trial (RCT) including patients with FEP aged 14-19 years recruited from Gregorio Marañón Hospital, Madrid, Spain. Patients will be randomly assigned to an intervention group, which will receive treatment as usual plus five modules of a psychological intervention through the mobile app (psychoeducation, recognition of symptoms and prevention of relapses, problem solving, mindfulness, and contact wall), or to a control group (standard care). The effectiveness of the intervention will be assessed by means of an extensive battery of clinical tests at baseline and at 3 months of follow-up. The primary outcome is reduction in psychotic and depressive symptoms; secondary outcomes comprise adherence, awareness, use of drugs, and quality of life. Data will be analyzed on an intention-to-treat (ITT) basis. Mixed model repeated-measures analysis will be used to explore the following effect: group × time interaction between the control group and the intervention group for clinical and functional variables during the follow-up period. Discussion: This is an innovative study for the assessment of a psychological intervention through a mobile app for patients with FEP during the critical period. This pilot RCT is intended to be a precursor to larger studies, which in turn could facilitate dissemination of mobile app therapy for patients with FEP. Ethics and Dissemination: The local ethics committee approved the study protocol. All participants must sign the informed consent, to participate. After finalizing the study, the results will be published. Trial registration: NCT03161249. NCT clinicaltrials.gov. Date of registration in primary registry 02 May 2017. clinicaltrials.gov.
| S-EPMC6370739 | biostudies-literature
Project description:BackgroundThe COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app.ObjectiveThe objectives of this study are (1) to evaluate the feasibility of a brief mindfulness-based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants.MethodsWe followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers' Sense of Efficacy Scale (TSES), the Self-Compassion Scale-Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations.ResultsParticipants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry.ConclusionsThis study aims to determine the feasibility and efficacy of the BM-MA, a digital mental health intervention developed using an existing mindfulness-based app, and assess its potential for widespread use.Trial registrationChinese Clinical Trial Registry ChiCTR2300068085; https://tinyurl.com/2d2x4bxk.International registered report identifier (irrid)DERR1-10.2196/56693.
| S-EPMC11541156 | biostudies-literature
Project description:BackgroundApproximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.ObjectiveThis paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.MethodsA two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).ResultsRecruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).ConclusionsIf the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.International registered report identifier (irrid)RR1-10.2196/18071.
| S-EPMC7532454 | biostudies-literature