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  Theme Issue (2018): Adolescent...

  Mar 26, 2019

  Improving the Youth HIV Prevention and Care Continuums: The Adolescent Medicine Trials Network for HIV/AIDS Interventions

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  Authors List:

  • Sonia Lee  
  • Bill G. Kapogiannis  
  • Susannah Allison  

  Abstract:

  Background: Epidemiologic and clinical information in the United States indicate that HIV transmission and acquisition among adolescents and young adults (youth) remain unchanged, without improvement. Interventions to prevent HIV transmission among youth are critically needed, as are interventions to improve adherence to all components of the continuum of care for youth living with HIV. Objective: The primary mission of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) is to conduct both independent and collaborative research that explores promising behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected and at-risk youth aged between 12 and 24. Methods: Through the ATN, the National Institutes of Health is supporting HIV interventional research for youth in the United States. Results: The ATN comprises 3 cooperative multiproject research programs and a coordinating center. Each program is led by a network hub and has well-defined research themes to assist, guide, and coordinate HIV research project activities. Conclusions: ATN activities encompass the full spectrum of research needs for youth, from HIV primary prevention for at-risk youth in the community to secondary and tertiary prevention with clinical management of HIV infection among youth living with HIV experiencing adherence challenges. International Registered Report Identifier (IRRID): DERR1-10.2196/12050

  • JMIR Res Protoc 2019;8(3):e12050

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  RCTs - Protocols/Proposals (eHealth)

  Mar 26, 2019

  Mobile Phone–Based Smoking-Cessation Intervention for Patients Undergoing Elective Surgery: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Marcus Bendtsen  
  • Catharina Linderoth  
  • Preben Bendtsen  

  Abstract:

  Background: Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)–based interventions can help individuals quit smoking. Objective: The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. Methods: A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change–enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments’ current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. Results: Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. Conclusions: Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. Trial Registration: ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008 International Registered Report Identifier (IRRID): PRR1-10.2196/12511

  • JMIR Res Protoc 2019;8(3):e12511

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  RCTs - Protocols/Proposals (funded,...

  Mar 26, 2019

  Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2...

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  Authors List:

  • Jessica E Bourne  
  • Jonathan P Little  
  • Mark R Beauchamp  
  • Julianne Barry  
  • Joel Singer  
  • Mary E Jung  

  Abstract:

  Background: Worldwide incidence of type 2 diabetes (T2D) is rapidly increasing. Given the numerous negative health consequences associated with T2D, prevention of this disease has become a priority. Lifestyle changes, including regular exercise, can reduce the onset of T2D in those at elevated risk. However, long-term adherence to exercise is often poor in this population. Existing lifestyle interventions targeting exercise are labor intensive and costly for staff and participants. Evidence-informed counseling delivered in a manner that reduces dependence on staff and facilitates self-regulatory skills could alleviate time and financial barriers while promoting independent exercise. Objective: This protocol outlines the design, recruitment, and proposed analysis of a brief, 2-week evidence-informed exercise counseling intervention combined with either high-intensity interval training (HIIT) or traditional moderate-intensity continuous training (MICT). Methods: Small Steps for Big Changes is a 2-arm randomized controlled trial that will examine the effectiveness of combining brief exercise counseling with HIIT or MICT on adherence to moderate and vigorous exercise over 1 year. Cardiorespiratory fitness will be assessed at baseline, post intervention (2 weeks), and at 6- and 12-month follow-up. Physical activity behavior will be examined at baseline, post intervention, and 3-, 6-, 9-, and 12-month follow-up. The impact of the intervention on psychosocial outcomes pertinent to exercise adherence will be examined. Results: Data collection was complete in March 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: The results of this brief intervention have the potential to inform future public health efforts designed to increase exercise in individuals at risk of T2D. Trial Registration: ClinicalTrials.gov NCT02164474; https://clinicaltrials.gov/ct2/show/NCT02164474 (Archived by WebCite at http://www.webcitation.org/74Hx1ipj6) International Registered Report Identifier (IRRID): DERR1-10.2196/11226

  • JMIR Res Protoc 2019;8(3):e11226

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  RCTs - Protocols/Proposals (funded,...

  Mar 25, 2019

  Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: Protocol for the Multicenter Randomized Hypertension and...

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  Authors List:

  • Stacie L Daugherty  
  • Suma Vupputuri  
  • Rebecca Hanratty  
  • John F Steiner  
  • Julie A Maertens  
  • Irene V Blair  
  • L Miriam Dickinson  
  • Laura Helmkamp  
  • Edward P Havranek  

  Abstract:

  Background: Medication nonadherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient’s ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies. Objective: The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat. Methods: The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients’ adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients’ prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes. Results: This study was funded by the National Heart, Lung, and Blood Institute. Enrollment and follow-up are ongoing and data analysis is expected to begin in late 2020. Planned enrollment is 1130 patients. On the basis of evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes. Conclusions: The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition—hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB). International Registered Report Identifier (IRRID): DERR1-10.2196/12498

  • JMIR Res Protoc 2019;8(3):e12498

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  Systematic Review Protocols

  Mar 25, 2019

  Digital Education for the Management of Chronic Wounds in Health Care Professionals: Protocol for a Systematic Review by the Digital Health Education...

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  Authors List:

  • Laura Martinengo  
  • Natalie Jia Ying Yeo  
  • Zheng Qiang Tang  
  • Kasturi D/O Markandran  
  • Bhone Myint Kyaw  
  • Lorainne Tudor Car  

  Abstract:

  Background: Digital education is “the act of teaching and learning by means of digital technologies.” Digital education comprises a wide range of interventions that can be broadly divided into offline digital education, online digital education, digital game-based learning, massive open online courses (MOOCs), psychomotor skills trainers, virtual reality environments, virtual patient simulations, and m-learning. Chronic wounds pose an immense economic and psychosocial burden to patients and the health care system, as caring for them require highly specialized personnel. Current training strategies face significant barriers, such as lack of time due to work commitments, distance from provider centers, and costs. Therefore, there is an increased need to synthesize evidence on the effectiveness of digital education interventions on chronic wounds management in health care professionals. Objective: Our main objective is to assess the effectiveness of digital education as a stand-alone approach or as part of a blended-learning approach in improving pre- and postregistration health care professionals’ knowledge, attitudes, practical skills, and behavior in the management of chronic wounds, as well as their satisfaction with the intervention. Secondary objectives are to evaluate patient-related outcomes, cost-effectiveness of the interventions, and any unfavorable or undesirable outcomes that may arise. Methods: This systematic review will follow the methodology as described in the Cochrane Handbook for Systematic Reviews of Interventions. As our systematic review is one of a series of reviews on digital education for health professionals’ education, we will use a previously developed search strategy. This search includes the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library), MEDLINE (Ovid), Embase (Ovid), Web of Science, the Educational Resource Information Centre (ERIC) (Ovid), PsycINFO (Ovid), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO), the ProQuest Dissertation and Theses database, and trial registries. Databases will be searched for studies published from January 1990 to August 2018. Two independent reviewers will screen the library for included studies. We will describe the screening process using a flowchart as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will extract the data using a previously developed, structured data extraction form. Included studies will be quality-assessed using the Risk of Bias tool from Cochrane. We will narratively summarize the data and, if possible, we will conduct a meta-analysis. We will use Cochrane’s RevMan 5.3 software for data analysis. Results: We have completed the screening of titles and abstracts for this systematic review and are currently selecting papers against our inclusion and exclusion criteria through full-text revision. We are expecting to complete our review by the end of April 2019. Conclusions: This systematic review will provide an in-depth analysis of digital education strategies to train health care providers in the management of chronic wounds. We consider this topic particularly relevant given the current challenges facing health care systems worldwide, including shortages of skilled personnel and a steep increase in the population of older adults as a result of a prolonged life expectancy. Trial Registration: PROSPERO CRD42018109971; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=109971 International Registered Report Identifier (IRRID): DERR1-10.2196/12488

  • JMIR Res Protoc 2019;8(3):e12488

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  RCTs - Protocols/Proposals (eHealth)

  Mar 22, 2019

  Enhanced Patient Activation in Cancer Care Transitions: Protocol for a Randomized Controlled Trial of a Tailored Electronic Health Intervention for Men With...

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  Authors List:

  • Mirjam Ekstedt  
  • Kristina Schildmeijer  
  • Camilla Wennerberg  
  • Lina Nilsson  
  • Carolina Wannheden  
  • Amanda Hellström  

  Abstract:

  Background: Prostate cancer has increased in incidence worldwide and is the leading cause of cancer death in 24 countries. The most common treatment is radical prostatectomy. However, surgery is associated with postoperative complications such as urinary incontinence and sexual dysfunction, causing decreased quality of life. If survivors are encouraged to be more active in self-care management, the symptom burden may decrease and quality of life may improve. An electronic health (eHealth) intervention based on motivational behavioral theory has been developed for this purpose. Objective: This study aimed to compare the effectiveness of standard care in combination with a tailored eHealth and mobile health self-management support system, electronic Patient Activation in Treatment at Home (ePATH), with standard care of adverse effects of prostate cancer treatment (urinary incontinence and sexual functioning) in men undergoing radical prostatectomy. The secondary aim was to test the effect on patient activation, motivation, overall well-being, and health literacy over time in and between groups. Methods: A pragmatic multicenter, block-randomized controlled trial with 2 study arms, standard care (control) and eHealth-assisted standard care (intervention), for patients undergoing radical prostatectomy. For 80% power, a sample of 242 men will need to be recruited. Results: Recruitment started in January 2018 and is expected to be completed by August 2019. Data collection will be completed in August 2020. The first cross-sectional results from this trial are anticipated to be published in January 2020. Conclusions: With the increasing number of prostate cancer survivors, attention should be paid to rehabilitation, psychosocial care, and support for endurance of self-care to reduce suffering from adverse treatment effects, poor quality of life, and depression because of postoperative complications. This project may increase knowledge of how patients can be supported to feel involved in their care and returning to as normal a life as possible. The anticipated effects of ePATH could improve health outcomes for individuals and facilitate follow-up for health care professionals. Trial Registration: International Standard Randomised Controlled Trial Number: 18055968; http://www.isrctn.com/ISRCTN18055968 (Archived by WebCite at http://www.isrctn.com/ISRCTN18055968). International Registered Report Identifier (IRRID): DERR1-10.2196/11625

  • JMIR Res Protoc 2019;8(3):e11625

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  RCTs - Protocols/Proposals (eHealth)

  Mar 22, 2019

  A Self-Regulation–Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Louise Poppe  
  • Ilse De Bourdeaudhuij  
  • Maïté Verloigne  
  • Laurent Degroote  
  • Samyah Shadid  
  • Geert Crombez  

  Abstract:

  Background: Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention “MyPlan 2.0” targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective: The aim of this paper is to thoroughly describe “MyPlan 2.0” and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behavior. Methods: A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients’ stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted. Results: The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019. Conclusions: This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time. International Registered Report Identifier (IRRID): DERR1-10.2196/12413

  • JMIR Res Protoc 2019;8(3):e12413

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  Grant Proposals (eHealth, funded)

  Mar 22, 2019

  Smartphone-Delivered Peer Physical Activity Counseling Program for Individuals With Spinal Cord Injury: Protocol for Development and Pilot Evaluation

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  Authors List:

  • Krista L Best  
  • François Routhier  
  • Shane N Sweet  
  • Emilie Lacroix  
  • Kelly P Arbour-Nicitopoulos  
  • Jaimie F Borisoff  

  Abstract:

  Background: Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to accrue health benefits. The Active Living Lifestyles program for individuals with SCI who use manual wheelchairs (ALLWheel) targets important psychological factors that are associated with LTPA uptake and adherence while overcoming some barriers associated with participation restrictions. Objective: The goal of the paper is to describe the protocol for the development and evaluation of the ALLWheel program for individuals with SCI who use manual wheelchairs. Methods: The first three stages of the Medical Research Council framework for developing and evaluating complex interventions (ie, preclinical, modeling, exploratory) are described. The preclinical phase will consist of scoping and systematic reviews and review of theory. The intervention will be modeled by expert opinions and consensus through focus groups and Delphi surveys with individuals with SCI, clinicians, and community partners. Finally, the feasibility and potential influence of the ALLWheel program on LTPA and psychological outcomes will be evaluated. Results: This project is funded by the Craig H Neilsen Foundation, the Fonds de Recherche du Québec–Santé, and the Canadian Disability Participation Project and is currently underway. Conclusions: Using peer trainers and mobile phone technology may help to cultivate autonomy-supportive environments that also enhance self-efficacy. Following a framework for developing and evaluating a novel intervention that includes input from stakeholders at all stages will ensure the final product (ie, a replicable intervention) is desirable to knowledge users and ready for evaluation in a randomized controlled trial. If effective, the ALLWheel program has the potential to reach a large number of individuals with SCI to promote LTPA uptake and adherence. International Registered Report Identifier (IRRID): RR1-10.2196/10798

  • JMIR Res Protoc 2019;8(3):e10798

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  Theme Issue (2018): Adolescent...

  Mar 22, 2019

  Community-Based, Point-of-Care Sexually Transmitted Infection Screening Among High-Risk Adolescents in Los Angeles and New Orleans: Protocol for a...

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  Authors List:

  • Chelsea Lee Shannon  
  • Maryann Koussa  
  • Sung-Jae Lee  
  • Jasmine Fournier  
  • Sue Ellen Abdalian  
  • Mary Jane Rotheram  
  • Jeffrey D Klausner  
  • Adolescent Medicine Trials Network CARES Team

  Abstract:

  Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents aged 15-24 years. Gay, bisexual, and transgender youth (GBTY), homeless youth, and youth with histories of drug use, mental health disorders, and incarceration are all at uniquely high risk for STIs. However, these adolescents often lack access to sexual health services. Objective: This study aims to use point-of-care STI tests in community-based settings to screen for and treat STIs in adolescents. Methods: We are recruiting 1500 HIV-uninfected youth and 220 HIV-infected youth from homeless shelters, GBTY organizations, and community health centers in Los Angeles, California and New Orleans, Louisiana. Study participants will receive STI screening every 4 months for 24 months. STI screening includes rapid HIV, syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae, and Hepatitis C virus testing. Trained paraprofessionals will conduct all STI testing. When a participant screens positive for an STI, they are either linked to a partner medical clinic or provided with same-day antibiotic therapy and expedited partner therapy. We will monitor STI prevalence among study participants as well as point-of-care test performance, linkage to care, and treatment outcomes. Results: The project was funded in 2016, and enrollment will be completed in 2019. Preliminary data analysis is currently underway. Conclusions: As STI rates continue to rise, it is important to improve access to screening and treatment services, particularly for high-risk adolescents. In this study, we aim to evaluate the use of point-of-care STI diagnostic tests in community-based organizations. We hope to determine the prevalence of STIs among these adolescents and evaluate the acceptability and feasibility of community-based STI screening and treatment. Trial Registration: ClinicalTrials.gov NCT03134833; https://clinicaltrials.gov/ct2/show/NCT03134833 International Registered Report Identifier (IRRID): DERR1-10.2196/10795

  • JMIR Res Protoc 2019;8(3):e10795

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  RCTs - Protocols/Proposals (non-eHealth)

  Mar 20, 2019

  The Effects of Positive Affect and Episodic Future Thinking on Temporal Discounting and Healthy Food Demand and Choice Among Overweight and Obese...

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  Authors List:

  • Sara M Levens  
  • Sara J Sagui-Henson  
  • Meagan Padro  
  • Laura E Martin  
  • Elisa M Trucco  
  • Nina A Cooperman  
  • Austin S Baldwin  
  • Angelos P Kassianos  
  • Noreen D Mdege  

  Abstract:

  Background: Unhealthy behaviors (eg, poor food choices) contribute to obesity and numerous negative health outcomes, including multiple types of cancer and cardiovascular and metabolic diseases. To promote healthy food choice, diet interventions should build on the dual-system model to target the regulation and reward mechanisms that guide eating behavior. Episodic future thinking (EFT) has been shown to strengthen regulation mechanisms by reducing unhealthy food choice and temporal discounting (TD), a process of placing greater value on smaller immediate rewards over larger future rewards. However, these interventions do not target the reward mechanisms that could support healthy eating and strengthen the impact of EFT-anchored programs. Increasing positive affect (PosA) related to healthy food choices may target reward mechanisms by enhancing the rewarding effects of healthy eating. An intervention that increases self-regulation regarding unhealthy foods and the reward value of healthy foods will likely have a greater impact on eating behavior compared with interventions focused on either process alone. Objective: This study aimed to introduce a protocol that tests the independent and interactive effects of EFT and PosA on TD, food choice, and food demand in overweight and obese adults. Methods: This protocol describes a factorial, randomized, controlled pilot study that employs a 2 (affective imagery: positive, neutral) by 2 (EFT: yes, no) design in which participants are randomized to 1 of 4 guided imagery intervention arms. In total, 156 eligible participants will complete 2 lab visits separated by 5 days. At visit 1, participants complete surveys; listen to the audio guided imagery intervention; and complete TD, food demand, and food choice tasks. At visit 2, participants complete TD, food demand, and food choice tasks and surveys. Participants complete a daily food frequency questionnaire between visits 1 and 2. Analyses will compare primary outcome measures at baseline, postintervention, and at follow-up across treatment arms. Results: Funding notification was received on April 27, 2017, and the protocol was approved by the institutional review board on October 6, 2017. Feasibility testing of the protocol was conducted from February 21, 2018, to April 18, 2018, among the first 32 participants. As no major protocol changes were required at the end of the feasibility phase, these 32 participants were included in the target sample of 156 participants. Recruitment, therefore, continued immediately after the feasibility phase. When this manuscript was submitted, 84 participants had completed the protocol. Conclusions: Our research goal is to develop novel, theory-based interventions to promote and improve healthy decision-making and behaviors. The findings will advance decision-making research and have the potential to generate new neuroscience and psychological research to further understand these mechanisms and their interactions. Trial Registration: ISRCTN Registry ISRCTN11704675; http://www.isrctn.com/ISRCTN11704675 (Archived by WebCite at http://www.webcitation.org/760ouOoKG) International Registered Report Identifier (IRRID): DERR1-10.2196/12265

  • JMIR Res Protoc 2019;8(3):e12265

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  Non-Randomized Study Protocols and...

  Mar 19, 2019

  Genetic Determinants of Ototoxicity During and After Childhood Cancer Treatment: Protocol for the PanCareLIFE Study

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  Authors List:

  • Eva Clemens  
  • Annelot JM Meijer  
  • Linda Broer  
  • Thorsten Langer  
  • Anne-Lotte LF van der Kooi  
  • André G Uitterlinden  
  • Andrica de Vries  
  • Claudia E Kuehni  
  • Maria L Garrè  
  • Tomas Kepak  
  • Jarmila Kruseova  
  • Jeanette F Winther  
  • Leontien C Kremer  
  • Eline van Dulmen-den Broeder  
  • Wim JE Tissing  
  • Catherine Rechnitzer  
  • Line Kenborg  
  • Henrik Hasle  
  • Desiree Grabow  
  • Ross Parfitt  
  • Harald Binder  
  • Bruce C Carleton  
  • Julianne Byrne  
  • Peter Kaatsch  
  • Antoinette am Zehnhoff-Dinnesen  
  • Oliver Zolk  
  • Marry M van den Heuvel-Eibrink  

  Abstract:

  Background: Survival rates after childhood cancer now reach nearly 80% in developed countries. However, treatments that lead to survival and cure can cause serious adverse effects with lifelong negative impacts on survivor quality of life. Hearing impairment is a common adverse effect in children treated with cisplatin-based chemotherapy or cranial radiotherapy. Ototoxicity can extend from high-tone hearing impairment to involvement of speech frequencies. Hearing impairment can impede speech and language and neurocognitive development. Although treatment-related risk factors for hearing loss following childhood cancer treatment have been identified, the individual variability in toxicity of adverse effects after similar treatment between childhood cancer patients suggests a role for genetic susceptibility. Currently, 12 candidate gene approach studies have been performed to identify polymorphisms predisposing to platinum-induced ototoxicity in children being treated for cancer. However, results were inconsistent and most studies were underpowered and/or lacked replication. Objective: We describe the design of the PanCareLIFE consortium’s work packages that address the genetic susceptibility of platinum-induced ototoxicity. Methods: As a part of the PanCareLIFE study within the framework of the PanCare consortium, we addressed genetic susceptibility of treatment-induced ototoxicity during and after childhood cancer treatment in a large European cohort by a candidate gene approach and a genome-wide association screening. Results: This study included 1124 survivors treated with cisplatin, carboplatin, or cranial radiotherapy for childhood cancer, resulting in the largest clinical European cohort assembled for this late effect to date. Within this large cohort we defined a group of 598 cisplatin-treated childhood cancer patients not confounded by cranial radiotherapy. The PanCareLIFE initiative provided, for the first time, a unique opportunity to confirm already identified determinants for hearing impairment during childhood cancer using a candidate gene approach and set up the first international genome-wide association study of cisplatin-induced direct ototoxicity in childhood cancer patients to identify novel allelic variants. Results will be validated in an independent replication cohort. Patient recruitment started in January 2015 and final inclusion was October 2017. We are currently performing the analyses and the first results are expected by the end of 2019 or the beginning of 2020.  Conclusions: Genetic factors identified as part of this pan-European project, PanCareLIFE, may contribute to future risk prediction models that can be incorporated in future clinical trials of platinum-based therapies for cancer and may help with the development of prevention strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/11868

  • JMIR Res Protoc 2019;8(3):e11868

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  RCTs - Protocols/Proposals (funded,...

  Mar 19, 2019

  Using Targeted mHealth Messages to Address Hypertension and Diabetes Self-Management in Cambodia: Protocol for a Clustered Randomized Controlled Trial

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  Authors List:

  • Annette L Fitzpatrick  
  • Maurits van Pelt  
  • Hen Heang  
  • Lesley Steinman  
  • Nicole Ide  
  • Chhorvann Chhea  
  • James P LoGerfo  

  Abstract:

  Background: Hypertension and diabetes represent the first and third highest contributors to global disability. While mobile health (mHealth) messaging programs have rapidly increased in low- and middle-income countries (LMIC), adaptations for specific patient health needs is a new approach to manage chronic conditions. Objective: The primary aim of this study is to develop and test an mHealth communication intervention using electronic data capture (by tablet) and voice messaging to improve hypertension and diabetes self-management in Cambodia. The secondary aim is to share results with the Cambodian Ministry of Health and development partners to inform health policy and develop strategies for hypertension and diabetes control. Methods: The study design is a cluster randomized controlled clinical trial randomizing each of 75 Community peer educators (PEs), trained and coordinated by MoPoTsyo Patient Information Center in Phnom Penh, into one of 3 groups of 25 (approximately 60 patients each) to receive either tablet+messages, tablet only, or no intervention (control). The total sample within each group includes 25 clusters and approximately 1500 patients located in 7 Operational Districts in rural regions or urban slums in Cambodia. The interventions (groups 1 and 2) were compared with usual PE monitoring without the tablet or mHealth messaging interventions. Focus groups and informant interviews were conducted to develop messages according to specific themes—medications adherence, laboratory testing, physician visits, obesity, smoking, and general lifestyle issues. Using the data received at monthly PE monitoring meetings, patients will receive specific messages based on their individual health challenges. Following the intervention completion, clinical and process outcomes will be compared with baseline metrics between groups. Results: PEs were randomized in July 2017, and the intervention was implemented in September 2017 through June 2018. Analyses are underway. Conclusions: This project is unique in its combination of electronic data transfer, which can be accessed immediately, with voice messages most relevant to individual patients’ needs. Positive results will indicate the value of using targeted messaging in patient-specific, self-management issues to improve hypertension and diabetes control. International Registered Report Identifier (IRRID): DERR1-10.2196/11614

  • JMIR Res Protoc 2019;8(3):e11614

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