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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: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: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:Background:Robot-assisted minimally invasive esophagectomy (RAMIE) reduces postoperative respiratory complications and enables meticulous mediastinal lymphadenectomy. However, whether adding a robotic abdominal procedure to a robotic thoracic procedure can result in better outcomes is unclear. We examined outcomes after total-RAMIE (T-RAMIE) and compared them with the outcomes after hybrid-RAMIE (H-RAMIE). Methods:Total of 227 patients who underwent robotic esophagectomy for esophageal cancer were included. T-RAMIE was defined as esophagectomy performed robotically in both the thoracic and abdominal cavities. Laparotomy was used instead of the robotic procedure in H-RAMIE. T-RAMIE was performed in 144 patients (63.4%), and propensity score matching produced 49 matched pairs from each group. Early and long-term clinical outcomes between the two groups were compared. Results:T-RAMIE was mostly performed for upper or mid-thoracic squamous cell carcinoma (n=119, 82.6%) and cervical anastomosis, and three-field lymphadenectomy was performed in 113 (78.5%) and 54 (37.5%) patients, respectively. One laparotomy conversion was necessary because of severe obesity. The propensity-matched analysis demonstrated that T-RAMIE showed a comparable 90-day mortality rate with H-RAMIE (0% vs. 6.1%, P=0.083). The incidence rates of total (63.3% vs. 63.3%; P=1.000), abdominal (8.2% vs. 14.3%; P=0.366), and respiratory complications (10.2% vs. 10.2%; P=1.000) were not different between two groups. The number of harvested abdominal lymph nodes was similar (12.4±9.0 vs. 12.3±8.9; P=0.992). Median follow-up duration for T-RAMIE and H-RAMIE was 16.3 and 23.5 months, respectively. Two-year overall survival rate (86.2% in T-RAMIE vs. 77.6% in H-RAMIE; P=0.150) and recurrence-free survival (76.6% in T-RAMIE vs. 62.2% in H-RAMIE; P=0.280) were comparable between the two groups. Conclusions:In this matched analysis, T-RAMIE and H-RAMIE showed comparable early outcomes and long-term survival. The low tendencies of early mortality and conversion rate of T-RAMIE suggest that it might be a safe alternative to open stomach mobilization and abdominal lymphadenectomy.

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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