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Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors.

ABSTRACT: Breast cancer is the most commonly diagnosed non-skin cancer in women and the leading cause of death among Hispanic women living in the United States. Relative to non-Hispanic white women, Hispanic women report poorer health related quality of life (HRQoL) after treatment. Although eHealth interventions delivered via Smartphones are a viable approach to addressing supportive care accessibility issues while also integrating multidisciplinary approaches for improving HRQoL, few eHealth interventions have been developed that specifically target Hispanic breast cancer survivors (BCS). This manuscript describes the methodology of a multi-site, randomized controlled behavioral trial investigating the feasibility and preliminary efficacy of a Smartphone application aimed at improving HRQoL and cancer-specific distress among Hispanic BCS. Participants will be randomized to receive the intervention application, My Guide (psychoeducation & self-management program), or the health education control condition application, My Health (health education), for six weeks. All participants will also receive weekly telecoaching to enhance adherence to both control and intervention conditions. We will measure the study's primary outcomes, general and disease-specific HRQoL and cancer-specific distress, at three time points: prior to, immediately after the intervention, and eight weeks after initial application use. My Guide may have the potential to improve HRQoL, and to address issues of limited access to supportive care among Hispanic women recovering from breast cancer treatment.

SUBMITTER: Yanez BR

PROVIDER: S-EPMC6040887 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors.

Yanez Betina R BR Buitrago Diana D Buscemi Joanna J Iacobelli Francisco F Adler Rachel F RF Corden Marya E ME Perez-Tamayo Alejandra A Guitelman Judy J Penedo Frank J FJ

Contemporary clinical trials 20171202

Breast cancer is the most commonly diagnosed non-skin cancer in women and the leading cause of death among Hispanic women living in the United States. Relative to non-Hispanic white women, Hispanic women report poorer health related quality of life (HRQoL) after treatment. Although eHealth interventions delivered via Smartphones are a viable approach to addressing supportive care accessibility issues while also integrating multidisciplinary approaches for improving HRQoL, few eHealth interventio ...[more]

PMID: 29198729

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Project description:BackgroundThe number of older adult gamers who play mobile games is growing worldwide. Earlier studies have reported that digital games provide cognitive, physical, and socioemotional benefits for older adults. However, current mobile games that understand older adults' gameplay experience and reflect their needs are very scarce. Furthermore, studies that have analyzed older adults' game experience in a holistic manner are rare.ObjectiveThe purpose of this study was to suggest mobile game design guidelines for adults older than 50 years from a holistic gaming experience perspective. Adopting a human-centric approach, this study analyzes middle-aged and older adults' gameplay experience and suggests practical design guides to increase accessibility and satisfaction.MethodsWe organized a living laboratory project called the "Intergenerational Play Workshop." In this workshop, 40 middle-aged and older adults (mean age 66.75 years, age range 50-85 years) played commercial mobile games of various genres with young adult partners for 1 month (8 sessions). Using a convergent parallel mixed-method design, we conducted a qualitative analysis of dialogue, game diaries, and behavioral observations during the workshop and a quantitative analysis of the satisfaction level of the game elements for the mobile games that they played.ResultsThis project was active from April 2019 to December 2021, and the data were collected at the workshops from July 1 to August 28, 2019. Based on the identified themes of positive and negative experiences from the qualitative data, we proposed 45 design guides under 3 categories: (1) cognitive and physical elements, (2) psychological and socioemotional elements, and (3) consumption contextual elements. Our empirical research could reaffirm the proposals from previous studies and provide new guidelines for improving the game design. In addition, we demonstrate how existing commercial games can be evaluated quantitatively by using the satisfaction level of each game's elements and overall satisfaction level.ConclusionsThe final guidelines were presented to game designers to easily find related information and enhance the overall understanding of the game experience of middle-aged and older adults.

Project description:BackgroundAlmost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that (1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment and (2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer.MethodsWe designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: (1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers' and to published guidelines, (2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and (3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically distributed study sites.DiscussionThis study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed.Trial registrationCliniclTrials.gov NCT03445559. Prospectively registered on February 26, 2018.

Project description:BackgroundIndividuals with physical disabilities experience higher rates of chronic health conditions than individuals without physical disabilities. Self-management programs that use health coaching are effective at eliciting health behavior change in health outcomes such as goal setting, adherence, and health care use. Additionally, web-based resources such as telehealth-based technologies, including SMSS text messaging, web-based applications, and educational multimedia content, can complement health coaching to improve health-related behaviors and the use of health services. The complexity of studies using these resources requires a fidelity protocol to ensure that health behavior studies are administered properly.ObjectiveThe My Health, My Life, My Way fidelity protocol provides methods, strategies, and procedures of a multifaceted telehealth program for individuals with permanent physical disabilities and chronic health conditions. This health behavior study is a randomized controlled trial with four study arms: (1) scheduled coaching calls with gamified rewards, (2) no scheduled coaching calls with gamified rewards, (3) scheduled coaching calls with fixed rewards, and (4) no scheduled coaching calls with fixed rewards. To guide the fidelity protocol developed, we used the National Institutes of Health Behavior Change Consortium framework (NIH BCC).MethodsThe fidelity intervention protocol was developed by using the 5 primary domains provided by the NIH BCC: study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Following the NIH BCC guidelines and implementing social cognitive theory, this study is designed to ensure that all study arms receive equal treatment across conditions and groups. Health coaches and providers will be trained to deliver consistent health coaching, and thus participants will receive appropriate attention. Educational content will be developed to account for health literacy and comprehension of the material. Multiple fidelity intervention steps such as coaching call logs, regular content review, and participant progress monitoring will translate to participants using the skills learned in their daily lives. Different monitoring steps will be implemented to minimize differences among the 4 treatment groups.ResultsMy Health, My Life, My Way has been approved by the institutional review board and will begin enrollment in January 2024 and end in December 2024, with results reported in early 2025.ConclusionsIntervention fidelity protocols are necessary to ensure that health behavior change studies can be implemented in larger real-world settings. The My Health, My Life, My Way fidelity protocol has used the guidelines by the NIH BCC to administer a telehealth intervention combined with health coaching for individuals with physical disabilities and chronic health conditions. This fidelity protocol can be used as a complementary resource for other researchers who conduct similar research using telehealth technologies and health coaching in real-world settings.Trial registrationClinicalTrials NCT05481593; https://clinicaltrials.gov/study/NCT05481593.International registered report identifier (irrid)PRR1-10.2196/53410.

Project description:BackgroundMy Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds.ObjectiveThis study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy).MethodsWe are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians).ResultsThis study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment.ConclusionsThis randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points.Trial registrationClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333.International registered report identifier (irrid)DERR1-10.2196/25955.

Project description:Sleep difficulties, particularly symptoms of insomnia and circadian disruption, are among the primary complaints of gynecologic cancer survivors before, during, and after treatment. Moreover, difficulty sleeping has been linked to poorer health-related quality of life and elevated symptom burden in this population. Although leading behavioral sleep interventions have demonstrated efficacy among cancer survivors, up to 50% of survivors are non-adherent to these treatments, likely because these interventions require labor-intensive behavior and lifestyle changes. Therefore, there is a need for more effective and acceptable approaches to diminish sleep disturbance among cancer survivors. This manuscript describes the methodology of a two-part study guided by the Multiphase Optimization Strategy (MOST) framework to identify a streamlined behavioral sleep intervention for gynecologic cancer survivors. Three candidate intervention components previously shown to decrease sleep disturbance will be evaluated, including sleep restriction, stimulus control, and systematic bright light exposure. Participants will be adult women with a history of non-metastatic gynecologic cancer who have completed primary treatment and who report current poor sleep quality. Fifteen participants will be recruited for Part 1 of the study, which will utilize qualitative methods to identify barriers to and facilitators of intervention adherence. Results will inform changes to the delivery of the candidate intervention components to promote adherence in Part 2, where 80 participants will be recruited and randomized to one of eight conditions reflecting every possible combination of the three candidate intervention components in a full factorial design. Participants will complete assessments at baseline, post-intervention, and 3-months post-intervention. Part 2 results will identify the combination of candidate intervention components that yields the most efficacious yet efficient 6-week intervention for diminishing sleep disturbance. This is the first known study to apply the MOST framework to optimize a behavioral sleep intervention and will yield a resource-efficient treatment to diminish sleep disturbance, improve health-related quality of life, and decrease symptom burden among gynecologic cancer survivors. ClinicalTrials.gov Identifier: NCT05044975.

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Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors.

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Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors.

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