scholarly journals A Web-Based Lifestyle Intervention Aimed at Improving Cognition in Patients With Cancer Returning to Work in an Outpatient Setting: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
A Josephine Drijver ◽  
Jaap C Reijneveld ◽  
Linda M P Wesselman ◽  
Martin Klein
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Treatment ◽  
Cognitive Functioning ◽  
Lifestyle Intervention ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Web Based ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Returning To Work

BACKGROUND A high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning. OBJECTIVE This study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work. METHODS The study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors. RESULTS Recruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals. CONCLUSIONS This is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible. CLINICALTRIAL Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/22670

scholarly journals A Web-Based Lifestyle Intervention Aimed at Improving Cognition in Patients With Cancer Returning to Work in an Outpatient Setting: Protocol for a Randomized Controlled Trial

10.2196/22670 ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. e22670
Author(s):  
A Josephine Drijver ◽  
Jaap C Reijneveld ◽  
Linda M P Wesselman ◽  
Martin Klein
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Treatment ◽  
Cognitive Functioning ◽  
Lifestyle Intervention ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Web Based ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Returning To Work

Background A high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning. Objective This study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work. Methods The study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors. Results Recruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals. Conclusions This is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible. Trial Registration Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407 International Registered Report Identifier (IRRID) DERR1-10.2196/22670

scholarly journals Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity. A mixed-method, single-arm feasibility study for RESTART- a randomized controlled trial

2020 ◽  
Author(s):  
Trygve Deraas ◽  
Laila Hopstock ◽  
André Henriksen ◽  
Bente Morseth ◽  
Anne Sofie Sand ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Lifestyle Intervention ◽  
Feasibility Study ◽  
Mixed Method ◽  
Intervention Program ◽  
Controlled Trial ◽  
Lifestyle Changes ◽  
Randomized Controlled ◽  
Exercise Induced

Abstract Background: Physical inactivity and obesity are global public health challenges. Older adults are important to target for prevention and management of disease and chronic conditions. However, many individuals struggle with maintaining increased physical activity (PA) and improved diet. This feasibility study provides the foundation for the RESTART trial, a randomized controlled trial (RCT) to test a complex intervention to facilitate favourable lifestyle changes older adults can sustain. The primary objective of this study was to investigate study feasibility (recruitment, adherence, side-effects and logistics) using an interdisciplinary approach.Methods: This mixed-method one-year prospective single-arm feasibility study was conducted in Tromsø, Norway from September 2017. We invited by mail randomly selected participants from the 7 th survey of the Tromsø Study (2015-16) aged 55-75 years with sedentary lifestyle, obesity and elevated cardiovascular risk. Participants attended a six-month complex lifestyle intervention program, comprising instructor-led high-intensive exercise and nutritionist- and psychologist-led counselling, followed by a six-month follow-up. All participants used a Polar activity tracker for daily activity monitoring during the intervention. Participants were interviewed three times throughout the study. Primary outcome was study feasibility measures.Results: We invited potential participants (n=75) by mail of which 27 % (n=20) agreed to participate. Telephone screening excluded four participants, and altogether 16 participants completed baseline screening.The intervention and test procedures of primary and secondary outcomes were feasible and acceptable for the participants. There were no exercise-induced injuries, indicating that the intervention program is safe. Participants experienced that the dietary and psychological counselling were delivered too early in the intervention and in too close proximity to the start of the exercise program. Minor logistic improvements were implemented throughout the intervention period.Conclusion: This study indicates that it is feasible to conduct a full-scale RCT of a multi- component randomised intervention trial, based on the model of the present study. No drop-outs due to exercise-induced injury indicates that the exercises were safe. While minor improvements in logistics were implemented during the intervention, we will improve recruitment and adherence strategies, rearrange schedule of intervention contents (exercise, diet and psychology) as well as improving the content of the dietary and behavioural counselling to maximize outcome effects in the RESTART protocol.

scholarly journals Interactive web-based lifestyle intervention and metabolic syndrome: findings from the Red Ruby (a randomized controlled trial)

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Leila Jahangiry ◽  
Davoud Shojaeizadeh ◽  
Mahdieh Abbasalizad Farhangi ◽  
Mehdi Yaseri ◽  
Kazem Mohammad ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Randomized Controlled Trial ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled

scholarly journals Telehealth versus Self-Directed Lifestyle Intervention to Promote Healthy Blood Pressure: A Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Mohamed Taher ◽  
Christina Yule ◽  
Heather Bonaparte ◽  
Sara Kwiecien ◽  
Charlotte Collins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Healthy Eating Index ◽  
Dietary Quality ◽  
Web Based ◽  
Randomized Controlled

Introduction: Weight loss, consumption of a Dietary Approaches to Stop Hypertension (DASH) dietary pattern, reduced sodium intake, and increased physical activity have been shown to lower blood pressure. Use of web-based tools and telehealth to deliver lifestyle counseling could be potentially scalable solutions to improve blood pressure through behavioral modification though limited data exists to support these approaches in clinical practice. Methods and analysis: This randomized controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour systolic blood pressure in patients with body mass index ≥ 25 kg/m2 and 24-hour SBP 120-160 mmHg. All participants receive personalized recommendations to improve dietary quality based on a web-based food frequency questionnaire, access to an online comprehensive weight management program, and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 3-months in 24-hour systolic blood pressure. Secondary outcomes include changes from baseline in Healthy Eating Index-2015 score, weight, waist circumference, and physical activity. Ethics and dissemination: The study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations. Trial registration number: ClinicalTrials.gov Identifier NCT03700710

A randomized controlled trial of a novel artificial-intelligence based smartphone application to optimize the management of cancer-related pain.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 76-76 ◽  
Author(s):  
Mihir M. Kamdar ◽  
Amanda Jayne Centi ◽  
Nils Fischer ◽  
Kamal Jethwani
Keyword(s):  
Artificial Intelligence ◽  
Randomized Controlled Trial ◽  
Cancer Pain ◽  
Cancer Treatment ◽  
Usual Care ◽  
Healthcare Utilization ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Patients With Cancer ◽  
Randomized Controlled

76 Background: Cancer pain affects 70-90% of advanced malignancy patients, resulting in impaired quality of life and increased healthcare utilization. Novel care delivery models are needed to optimize care for patients dealing with cancer-related pain in between clinic visits. ePAL is a smartphone application(app) that regularly monitors pain and uses artificial intelligence(AI) to differentiate urgent from non-urgent issues to intercede in real time. The purpose of this randomized controlled trial was to determine ePAL's impact on pain severity, attitudes toward cancer treatment, and healthcare utilization in patients with cancer pain. Methods: MGH Palliative Care Clinic Patients with pain from metastatic, solid-organ cancer (n=112) were recruited and randomized to either a control group (n=56) that received usual care or an intervention group (n=56) that used the ePAL app in addition to usual care for 8 weeks. The app assessed pain 3 times/week and questionnaires about pain (BPI), attitudes towards cancer treatment(BQ-II), and general anxiety(GAD-7) were given at 0, 4, and 8 weeks. A repeated measures mixed model approach assessed how outcome measures changed over time. Models controlled for baseline differences at enrollment and random slopes in addition to baseline depression score, age and sex(alpha=0.05). Results: Pain severity (BPI) and negative attitudes toward cancer pain treatment (BQ-II) decreased significantly for those using the app compared to controls(coeff. -0.09, 95% CI: -0.17, -0.007, p=0.034 and coeff. -0.037, 95% CI: -0.072, -0.001, p=0.042 respectively). Anxiety scores increased for those using ePAL compared to controls (coeff. 0.21, 95% CI: 0.039, 0.37, p=0.015). Over 8-weeks, ePAL users had 40% fewer inpatient hospital admissions compared to controls (n=15 vs. n=25, p=0.048). Conclusions: To our knowledge, this is the first mobile app to utilize AI and clinical algorithms to significantly decrease pain and reduce overall inpatient hospitalizations in patients with cancer-related pain. Clinical trial information: NCT02069743.

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