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Development and Feasibility of a Mobile Health-Supported Comprehensive Intervention Model (CIMmH) for Improving the Quality of Life of Patients With Esophageal Cancer After Esophagectomy: Prospective, Single-Arm, Nonrandomized Pilot Study.

ABSTRACT: BACKGROUND:Patients with esophageal cancer often experience clinically relevant deterioration of quality of life (QOL) after esophagectomy owing to malnutrition, lack of physical exercise, and psychological symptoms. OBJECTIVE:This study aimed to evaluate the feasibility, safety, and efficacy of a comprehensive intervention model using a mobile health system (CIMmH) in patients with esophageal cancer after esophagectomy. METHODS:Twenty patients with esophageal cancer undergoing the modified McKeown surgical procedure were invited to join the CIMmH program with both online and offline components for 12 weeks. The participants were assessed before surgery and again at 1 and 3 months after esophagectomy. QOL, depressive symptoms, anxiety, stress, nutrition, and physical fitness were measured. RESULTS:Of the 20 patients, 16 (80%) completed the program. One month after esophagectomy, patients showed significant deterioration in overall QOL (P=.02), eating (P=.005), reflux (P=.04), and trouble with talking (P<.001). At the 3-month follow-up, except for pain (P=.02), difficulty with eating (P=.03), dry mouth (P=.04), and trouble with talking (P=.003), all other QOL dimensions returned to the preoperative level. There were significant reductions in weight (P<.001) and BMI (P=.02) throughout the study, and no significant changes were observed for physical fitness measured by change in the 6-minute walk distance between baseline and the 1-month follow-up (P=.22) or between baseline and the 3-month follow-up (P=.52). Depressive symptoms significantly increased 1 month after surgery (P<.001), while other psychological measures did not show relevant changes. Although there were declines in many measures 1 month after surgery, these were much improved at the 3-month follow-up, and the recovery was more profound and faster than with traditional rehabilitation programs. CONCLUSIONS:The CIMmH was feasible and safe and demonstrated encouraging efficacy testing with a control group for enhancing recovery after surgery among patients with esophageal cancer in China. TRIAL REGISTRATION:Chinese Clinical Trial Registry (ChiCTR-IPR-1800019900); http://www.chictr.org.cn/showprojen.aspx?proj=32811.

SUBMITTER: Cheng C

PROVIDER: S-EPMC7463393 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Development and Feasibility of a Mobile Health-Supported Comprehensive Intervention Model (CIMmH) for Improving the Quality of Life of Patients With Esophageal Cancer After Esophagectomy: Prospective, Single-Arm, Nonrandomized Pilot Study.

Cheng Chao C Ho Rainbow Tin Hung RTH Guo Yan Y Zhu Mengting M Yang Weixiong W Li Yiran Y Liu Zhenguo Z Zhuo Shuyu S Liang Qi Q Chen Zhenghong Z Zeng Yu Y Yang Jiali J Zhang Zhanfei Z Zhang Xu X Monroe-Wise Aliza A Yeung Sai-Ching SC

Journal of medical Internet research 20200818 8

<h4>Background</h4>Patients with esophageal cancer often experience clinically relevant deterioration of quality of life (QOL) after esophagectomy owing to malnutrition, lack of physical exercise, and psychological symptoms.<h4>Objective</h4>This study aimed to evaluate the feasibility, safety, and efficacy of a comprehensive intervention model using a mobile health system (CIMmH) in patients with esophageal cancer after esophagectomy.<h4>Methods</h4>Twenty patients with esophageal cancer underg ...[more]

PMID: 32808933

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Project description:BackgroundHealth behavior and weight management interventions for cancer survivors have the potential to prevent future cancer recurrence and improve long-term health; however, their translation can be limited if the intervention is complex and involves high participant burden. Mobile health (mHealth) offers a delivery modality to integrate interventions into daily life routines.ObjectiveThe objective of this study was to evaluate the effects of a one-group trial with a pre-post evaluation design on engagement (use and acceptability), physiological (weight), behavioral (diet and physical activity), and other secondary outcomes.MethodsThe 10-week intervention consisted of mHealth components (self-monitoring of selected diet behaviors via daily text messages, wireless devices to automatically track weight and steps) and 4 motivational interviewing-based technology-assisted phone sessions with a nonprofessionally trained counselor. Participants were overweight breast cancer survivors who had completed treatment and owned a smartphone. Weight was measured objectively; diet and physical activity were measured with brief self-reported questionnaires.ResultsTen women participated; they had a mean age of 59 years (SD 6), 50% belonged to a racial or ethnic minority group, 50% had some college or less, and 40% reported using Medicaid health insurance. Engagement was high: out of 70 days in total, the mean number of days recording steps via the wristband pedometer was 64 (SD 7), recording a weight via the scale was 45 (SD 24), and responding to text messages was 60 (SD 13); 100% of participants completed all 4 calls with the counselor. Most (90%) were very likely to participate again and recommend the program to others. Mean weight in pounds decreased (182.5 to 179.1, mean change -3.38 [SD 7.67]), fruit and vegetable daily servings increased (2.89 to 4.42, mean change 1.53 [SD 2.82]), and self-reported moderate physical activity increased in metabolic equivalent of task (MET) minutes per week (2791 to 3336, mean change 545 [SD 1694]).ConclusionsFindings support the conduct of a fully powered trial to evaluate the efficacy of mHealth as a feasible intervention modality for breast cancer survivors. Future research should employ accelerometer-based physical activity assessment and consider development of an all-in-one app to integrate devices, messaging, and educational content and other mHealth approaches to support behavioral counselors conducting weight management interventions.Trial registrationClinicalTrials.gov NCT02387671; https://clinicaltrials.gov/ct2/show/NCT02387671 (Archived by WebCite at http://www.webcitation.org/6hGEuttbZ).

Project description:Importance: Reducing poststroke sedentary behavior is important for reducing recurrent stroke risk, yet interventions to achieve this are scant.Objective: To assess the feasibility of, and estimate change in sedentary behavior over time associated with, a behavioral intervention.Design: Single-arm delayed baseline with postintervention and 8-wk follow-up assessment.Setting: Community based.Participants: Ambulatory, community-dwelling people with chronic stroke and reported ?6 hr daily sitting time (N = 21).Intervention: Activating Behavior for Lasting Engagement (ABLE) was delivered by an occupational therapist 3×/wk for 4 wk. ABLE involves activity monitoring, activity scheduling, self-assessment, and collaborative problem solving.Outcomes and measures: Feasibility (participant safety, adherence, satisfaction, and reliable intervention delivery) was assessed against preestablished benchmarks. Changes over time in sedentary behavior (assessed with an ActivPAL micro3 device) and participation (Stroke Impact Scale-Participation subscale) were described.Results: ABLE was safe (0 serious adverse events), adhered to (11.95 sessions/participant), and reliably delivered (90.00%-97.50% adherence). Participant satisfaction was unmet (Client Satisfaction Questionnaire-8, M = 28.75, SD = 3.84). ABLE was associated with a mean group reduction in prolonged sitting of 54.95 min (SD = 81.10) at postintervention and 14.08 (SD = 58.95) at follow-up. ABLE was associated with a negligible mean group increase over time in participation at postintervention (M = 1.48%, SD = 8.52) and follow-up (M = 1.33%, SD = 15.38).Conclusions and relevance: The ABLE intervention is feasible and may be associated with within-group reduction in sedentary behavior over time. Further refinement is indicated.What this article adds: The ABLE intervention uses engagement in meaningful daily activities to reduce sedentary behavior after stroke. These findings suggest that ABLE can be delivered safely and consistently. Further research is required to enhance participant satisfaction and determine the effects of ABLE on stroke survivors' sedentary behavior.

Project description:BackgroundThere is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups.ObjectiveThis study aims to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, which incorporates evidence-based practices such as cognitive behavioral therapy and acceptance and commitment therapy. A total of 3 brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, are evaluated. The primary aim is to determine the feasibility of the study methods and interventions in preparation for a definitive randomized controlled trial.MethodsThe study used a fully remote, parallel, multi-arm, external pilot randomized controlled trial, with 3 intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included 4 self-report measures of mental health and well-being, completed at baseline (time point 0 [t0]), postintervention (time point 1 [t1]), and the 1-month follow-up (time point 2 [t2]). Secondary outcomes were analyzed via linear mixed-effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated.ResultsData were collected between January and March of 2021. A total of 383 working adult participants meeting trial eligibility were randomized, of whom 356 (93%) were retained at t2. Objective engagement data showed that 67.8% (196/289) of participants randomized to an intervention arm completed their intervention. Overall, 87.1% (203/233) of participants reported being satisfied or very satisfied with their intervention and rated the quality of their intervention as good or excellent. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43 (95% CI 0.23-0.64). All the improvements were maintained at t2.ConclusionsThe study methods were feasible, and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments were noted. Preliminary efficacy findings suggest that the study interventions may result in improved mental health outcomes when offered to working adults.Trial registrationISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011.

Project description:BACKGROUND:Patients with frozen shoulder show limited shoulder mobility often accompanied by pain. Common treatment methods include physiotherapy, pain medication, administration of corticosteroids, and surgical capsulotomy. Frozen shoulder often lasts from months to years and mostly affects persons in the age group of 40 to 70 years. It severely reduces the quality of life and the ability to work. OBJECTIVE:The objective of this study was to evaluate the feasibility of a mobile health (mHealth) intervention that supports patients affected by "stage two" frozen shoulder. Patients were supported with app-based exercise instructions and tools to monitor their training compliance and progress. These training compliance and progress data supplement the patients' oral reports to the physiotherapists and physicians and can assist them in therapy adjustment. METHODS:In order to assess the feasibility of the mHealth intervention, a pilot study of a newly developed app for frozen shoulder patients was conducted with 5 patients for 3 weeks. The main function of the app was the instruction for exercising at home. Standardized questionnaires on usability such as System Usability Scale (SUS) and USE (Usefulness, Satisfaction, and Ease of use), and Technology Acceptance Model-2 (TAM-2) were completed by the study participants at the end of the study. Additionally, a nonstandardized questionnaire was completed by all patients. The correctness of the exercises as conducted by the patients was assessed by a physiotherapist at the end of the study. The mobility of the shoulder and pain in shoulder movement was assessed by a physiotherapist at the start and the end of the study. RESULTS:The pilot study was successfully conducted, and the app was evaluated by the patients after 3 weeks. The results of the standardized questionnaires showed high acceptance (TAM-2) and high usability (SUS) of the developed app. The overall usability of the system as assessed by the SUS questionnaire was very good (an average score of 88 out of 100). The average score of the TAM-2 questionnaire on the intention to further use the app was 4.2 out of 5, which indicated that most patients would use the app if further available. The results of the USE questionnaires highlighted that the patients learned how to use the app easily (an average score of 4.2 out of 5) and were satisfied with the app (an average score of 4.7 out of 5). The frequency of app usage and training was very high based on patient reports and verified by analysis of the usage data. The patients conducted the exercises almost flawlessly. CONCLUSIONS:Our results indicate the feasibility of the mHealth intervention, as the app was easy to use and frequently used by the patients. The app supported the patients' physiotherapy by providing clear exercising instructions.

Project description:BackgroundDuring the COVID-19 pandemic, rehabilitation providers and consumers adopted telehealth practices at unprecedented rates. Multiple prepandemic studies demonstrate the feasibility and comparable efficacy between in-clinic and remote treatment for certain impairments caused by stroke, such as upper extremity weakness and impaired motor function. However, less guidance has been available regarding gait assessment and treatment. Despite this limitation, safe and effective gait treatment is fundamental to optimizing health and well-being after stroke and should be considered a treatment priority, including during the COVID-19 pandemic.ObjectiveThis study explores the feasibility of using telehealth to deliver gait treatment using a wearable gait device, the iStride device, to stroke survivors during the 2020 pandemic. The gait device is used to treat hemiparetic gait impairments caused by stroke. The device alters the user's gait mechanics and creates a subtle destabilization of the nonparetic limb; therefore, supervision is required during its usage. Before the pandemic, treatment with the gait device had been provided in person to appropriate candidates using a combination of physical therapists and trained personnel. However, upon the emergence of the COVID-19 pandemic, in-person treatment was halted in adherence to pandemic guidelines. This study investigates the feasibility of 2 remote delivery treatment models with the gait device for stroke survivors.MethodsParticipants were recruited during the first half of 2020 after the onset of the pandemic and included 5 individuals with chronic stroke (mean age 72 years; 84 months post stroke). Four participants were previous gait device users who transitioned to the telehealth delivery model to continue their gait treatment remotely. The fifth participant performed all study-related activities, from recruitment through follow-up, remotely. The protocol included virtual training for the at-home care partner, followed by 3 months of remote treatment with the gait device. Participants were instructed to wear gait sensors during all treatment activities. To assess feasibility, we monitored the safety of the remote treatment, compliance with protocol activities, acceptability of the telehealth treatment delivery, and preliminary efficacy of the gait treatment. Functional improvement was measured using the 10-Meter Walk Test, the Timed Up and Go Test, and the 6-Minute Walk Test, and quality of life was assessed using the Stroke-Specific Quality of Life Scale.ResultsNo serious adverse events occurred, and participants rated high acceptance of the telehealth delivery. Protocol compliance averaged 95% of treatment sessions, 100% of assessments, and 85% of sensor usage during treatment. After 3 months of treatment, the average improvement in each functional outcome exceeded the minimal clinically important difference or minimal detectable change value.ConclusionsRemote treatment delivery with the gait device appeared feasible with care partner support. Gait treatment using telehealth may be useful to offset negative immobility impacts for those requiring or preferring remote care during the pandemic or otherwise.Trial registrationClinicalTrials.gov NCT04434313; https://clinicaltrials.gov/ct2/show/NCT04434313.

Dataset Information

Development and Feasibility of a Mobile Health-Supported Comprehensive Intervention Model (CIMmH) for Improving the Quality of Life of Patients With Esophageal Cancer After Esophagectomy: Prospective, Single-Arm, Nonrandomized Pilot Study.

Publications

Development and Feasibility of a Mobile Health-Supported Comprehensive Intervention Model (CIMmH) for Improving the Quality of Life of Patients With Esophageal Cancer After Esophagectomy: Prospective, Single-Arm, Nonrandomized Pilot Study.

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