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Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT).

ABSTRACT: BACKGROUND:There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. METHODS:This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3?months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12?months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. DISCUSSION:This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination. TRIAL REGISTRATION:The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

SUBMITTER: Lidington E

PROVIDER: S-EPMC6961395 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT).

Lidington Emma E McGrath Sophie E SE Noble Jillian J Stanway Susannah S Lucas Amanda A Mohammed Kabir K van der Graaf Winette W Husson Olga O

Trials 20200115 1

<h4>Background</h4>There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management.<h4>Methods</h4>This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use ...[more]

PMID: 31941539

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Project description:INTRODUCTION:Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acute treatment phase, this is rarely available in subsequent phases. Internet interventions for breast cancer survivors could provide additional psychological support, as they are easily accessible and may be effective. However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population. This trial aims to test whether Optimune, a novel Internet intervention we developed for that purpose, leads to improvements in quality of life and relevant lifestyle habits over the course of 3 to 6 months. METHODS:This randomized controlled trial (RCT) will include 360 female breast cancer survivors who have completed the active tumour eradication phase. Participants will be recruited from various settings, including web-based advertisements and Internet forums in German-speaking countries. The main inclusion criteria are a breast cancer diagnosis less than 5 years ago and completion of acute treatment at least 1 month ago, as verified by discharge letter from an oncology treatment centre. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to Optimune after a delay of 3 months (CAU/wait list control), or (2) a treatment group that may also use CAU and will receive 12-month access to Optimune immediately after randomization. The three primary endpoints are quality of life, physical activity and diet quality, assessed with the World Health Organization Quality of Life Questionnaire, the International Physical Activity Questionnaire and the Food Quality Questionnaire, at 3 months post-baseline; secondary outcomes include cancer-related fatigue, emotional stress, depression, anxiety, fear of progression, insomnia, usefulness of the programme and negative treatment effects. Online assessments are conducted at baseline (T0), 3 months (T1) and 6 months (T2). DISCUSSION:Results of this RCT are expected to extend the body of knowledge with regard to the effectiveness of CBT-based Internet interventions for female breast cancer survivors. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03643640. Registered on 23 August 2018.

Project description:Young children are prone to low levels of physical activity in childcare. Researchers have identified that preschoolers tend to be more active outdoors than indoors, with higher activity levels occurring during the first 10 minutes of outdoor playtime. Additionally, interventions incorporating either staff training or the inclusion of play equipment have been effective at increasing children's activity in this setting. As such, the overarching objective of the Supporting Physical Activity in the Childcare Environment (SPACE) intervention is to improve the physical activity levels of preschoolers during childcare hours, utilizing a combination of the above components. The purpose of this manuscript is to provide a detailed account of the protocol, innovative methods, and evaluation plans used in the implementation of the SPACE study; in an effort to support the development of further research in this field.The SPACE study, a cluster randomized controlled trial, involves 22 childcare centres randomly allocated to either the experimental (n = 11) or the control (n = 11) group. Childcare centres receiving the intervention will adopt an 8-week physical activity intervention with the following components: 1. shorter, more frequent bouts of outdoor playtime (4 × 30 min periods rather than 2 × 60 min periods); 2. new portable play equipment (e.g., obstacle course, balls); and, 3. staff training (1 × 4 hr workshop). Actical accelerometers will be used to assess total physical activity with measurements taken at baseline (i.e., week 0), immediately post-intervention (i.e., week 8), and at 6- and 12-month follow-up. As secondary objectives, we aim to evaluate the effectiveness of the intervention on preschoolers': a) sedentary time; b) standardized body mass index scores (percentiles); c) health-related quality of life; and childcare providers' physical activity-related knowledge and self-efficacy to implement physical activity.The SPACE study aims to increase the low levels of physical activity observed within childcare centres. The findings of this work may be useful to policy makers and childcare providers to consider modifications to the current childcare curriculum and associated outdoor play time.ISRCTN70604107 (October 8, 2014).

Project description:BackgroundPatients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. There is a need to improve the quality of locoregional and systemic decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. We are now conducting a randomized controlled trial (RCT) of an online decision tool-called iCanDecide, which we expect will help patients with these difficult decisions. Furthermore, the results of this RCT will be highly relevant to future breast cancer patients making these decisions and to their clinicians.MethodsThis is a two-arm randomized controlled trial with the target of 222 participants per arm. Participants are recruited from 25 surgical practices (total 40 surgeons) and 2 medical oncology practices (total 2 oncologists) in Michigan, Georgia, Tennessee, and California. Participants are newly-diagnosed female breast cancer patients between 21 and 84 years, with stage I-II invasive breast cancer or ductal carcinoma in situ (DCIS) and who are eligible for and considering either mastectomy or lumpectomy with radiation, and who may be eligible for adjuvant systemic treatment.The RCT tests an interactive, tailored website, called iCanDecide (intervention arm), compared to a static version of the website (control arm). The static control arm is designed to include the same basic content as the intervention version, but without tailoring and interactive features. The primary outcome includes the rate of making a high-quality decision. The hypothesis is that patients randomized to the interactive version of iCanDecide will have higher rates of high quality decisions (informed and values-concordant), and will appraise their decision-making process more positively, for both surgical and systemic treatment.DiscussionThe goal of this study is to evaluate the impact of the iCanDecide interactive website on decision-making for locoregional and systemic breast cancer treatments. The results of this study will be important for future breast cancer patients and their clinicians as we determine how to better individualize decision making across this complex treatment landscape.

Project description:BackgroundAlzheimer's disease and related dementias (ADRD) impact a woman's life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers. Making decisions about mammography screening for women with ADRD is stressful. There are no data that suggest that breast cancer screening helps women with ADRD live longer or better. Decision aids may improve the quality of decision-making about mammography for ADRD patients and may inform family caregivers about the risks, benefits, and need for decision-making around mammography screening.Methods/designThe Decisions about Cancer Screening in Alzheimer's Disease (DECAD) trial, a randomized controlled clinical trial, will enroll 426 dyads of older women with ADRD (≥75 years) and a family caregiver from clinics and primary-care practices in Indiana to test a novel, evidence-based decision aid. This decision aid includes information about the impact of ADRD on life expectancy, the benefit of mammograms, and the impact on the quality of life for older women with ADRD. Dyads will be randomized to receive the decision aid or active control information about home safety. This trial will examine the effect on the caregiver's decisional conflict (primary outcome) and the caregiver's decision-making self-efficacy (secondary outcome). A second follow-up at 15 months will include a brief, semi-structured interview with the caregiver regarding the patient's experience with mammograms and decision-making about mammograms. At the same time, a review of the patient's electronic medical record (EMR) will look at discussions about mammography with their primary-care physician and mammogram orders, receipt, results, and burden (e.g., additional diagnostic procedures due to false-positive results, identification of an abnormality on the screening exam but further work-up declined, and identification of a clinically unimportant cancer). A third follow-up at 24 months will extract EMR data on mammogram orders, occurrences, results, and the burden of mammograms.DiscussionWe hypothesize that caregivers who receive the decision aid will have lower levels of decisional conflict and higher levels of decision-making self-efficacy compared to the control group. We also hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD.Trial registrationClinical Trials Register, NCT03282097 . Registered on 13 September 2017.

Project description:Background:Half of all patients with diabetes develop diabetic peripheral neuropathy (DPN), a complication leading to reduced mobility and quality of life. Although there are no proven pharmacologic approaches to reduce DPN risk or slow its progression, evidence suggests that physical activity may improve symptoms and enhance peripheral nerve regeneration. Objective:The aim of the study will be to determine the impact of an intense lifestyle intervention on neuropathy progression and quality of life in individuals with DPN. Design:The study will be a randomized controlled trial. Setting:The study will be conducted at 2 academic medical centers. Participants:The participants will be 140 individuals with type 2 diabetes and mild to moderate DPN. Intervention:The intervention group will receive 18 months of supervised exercise training, actigraphy-based counseling to reduce sedentary behavior, and individualized dietary counseling. Control group participants will receive diet and activity counseling at baseline and at 9 months. Measurements:The primary outcomes are neuropathy progression as measured by intraepidermal nerve fiber density in a distal thigh skin biopsy and the Norfolk Quality of Life-Diabetic Neuropathy score. Secondary outcomes include pain, gait, balance, and mobility measures. Limitations:Due to the combined intervention approach, this protocol will not be able to determine which intervention components influence outcomes. There also may be difficulty with participant attrition during the 18-month study intervention. Conclusions:The Activity for Diabetic Polyneuropathy (ADAPT) protocol resulted from a collaboration between physical therapists and neurologist researchers that includes as primary outcomes both a quality-of-life measure (NQOL-DN) and a physiologic biomarker (IENFD). It has the potential to demonstrate that an intensive lifestyle intervention may be a sustainable, clinically effective approach for people with DPN that improves patient outcomes and can have an immediate impact on patient care and future clinical trials.

Project description:Diabetes is predicted to increase in incidence by 42% from 1995 to 2025. Although most adults with diabetes seek care from primary care practices, adherence to treatment guidelines in these settings is not optimal. Many practices lack the infrastructure to monitor patient adherence to recommended treatment and are slow to implement changes critical for effective management of patients with chronic conditions. Supporting Practices to Adopt Registry-Based Care (SPARC) will evaluate effectiveness and sustainability of a low-cost intervention designed to support work process change in primary care practices and enhance focus on population-based care through implementation of a diabetes registry.SPARC is a two-armed randomized controlled trial (RCT) of 30 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN). Participating practices (including control groups) will be introduced to population health concepts and tools for work process redesign and registry adoption at a meeting of practice-level implementation champions. Practices randomized to the intervention will be assigned study peer mentors, receive a list of specific milestones, and have access to a physician informaticist. Peer mentors are clinicians who successfully implemented registries in their practices and will help champions in the intervention practices throughout the implementation process. During the first year, peer mentors will contact intervention practices monthly and visit them quarterly. Control group practices will not receive support or guidance for registry implementation. We will use a mixed-methods explanatory sequential design to guide collection of medical record, participant observation, and semistructured interview data in control and intervention practices at baseline, 12 months, and 24 months. We will use grounded theory and a template-guided approach using the Consolidated Framework for Implementation Research to analyze qualitative data on contextual factors related to registry adoption. We will assess intervention effectiveness by comparing changes in patient-level hemoglobin A1c scores from baseline to year 1 between intervention and control practices.Findings will enhance our understanding of how to leverage existing practice resources to improve diabetes care in primary care practices by implementing and using a registry. SPARC has the potential to validate the effectiveness of low-cost implementation strategies that target practice change in primary care.NCT02318108.

Project description:Translation of knowledge and skills from classroom settings to clinical practice is a major challenge in healthcare training, especially for behavioral interventions. For example, screening, brief intervention, and referral to treatment (SBIRT) is a highly-promoted approach to identifying and treating individuals at risk for alcohol or drug problems, yet effective, routine use of SBIRT has lagged.The objective of this paper is to describe the development, pilot testing, and trial protocol of a mobile app based on the theory of planned behavior (TPB) to promote SBIRT skill translation and application.Intended for use after classroom training occurs, the mobile app has three primary functions designed to increase behavioral intent to deliver SBIRT: (1) review skills (ie, address knowledge and beliefs about SBIRT), (2) apply skills with patients (ie, build confidence and perceived behavioral control), and (3) report performance data (ie, increase accountability and social norms and/or influence). The app includes depression and anxiety screening tools due to high comorbidity with substance use. A randomized controlled trial (RCT) is in progress among health and social service learners (N=200) recruited from 3 universities and 6 different training programs in nursing, social work, internal medicine, psychiatry, and psychology. Participants are randomized to SBIRT classroom instruction alone or classroom instruction plus app access prior to beginning their field placement rotations. TPB-based data are collected via Qualtrics or via the mobile app pre-post and SBIRT utilization, weekly for 10 weeks. Key outcomes include the frequency of and self-reported confidence in delivery of SBIRT.Beta testing with advanced practice nursing students (N=22) indicated that the app and its associated assessment tools were acceptable and useful. The system usability scale (SUS) mean was 65.8 (n=19), which indicated that the SBIRT app was acceptable but could benefit from improvement. Indeed, modifications were implemented prior to starting the trial. Enrollment of trial participants began in September 2016. Results are expected by December 2017.This report describes the process of TPB-based app development and testing, and the protocol for a RCT to determine the effectiveness of the app in enhancing skill translation. If effective, this approach could improve SBIRT implementation, fidelity, and clinical outcomes.

Project description:BackgroundHeart failure (HF) is the leading cause of hospitalization among older adults in the United States. There are substantial racial and geographic disparities in HF outcomes, with patients living in southern US states having a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight monitoring and physical activity, are extremely important in improving HF outcomes; however, patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) have become a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable and scalable and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also becoming increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes.ObjectiveThis randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors.MethodsA total of 200 participants with HF, aged ≥45 years, will be recruited and randomized into 2 groups: the SCDG playing group (intervention group) and sensor-only group (control group). Both groups will receive a weight scale, physical activity tracker, and accompanying app, whereas only the intervention group will play the SCDG. This design, thereby, assesses the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention. They will also complete a third posttest at 24 weeks to assess the maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight monitoring and physical activity) and distal outcomes (HF hospitalization, quality of life, and functional status) between baseline and weeks 6, 12, and 24. The primary outcome measured will be days with weight monitoring, for which this design provides at least 80% power to detect differences between the 2 groups.ResultsRecruitment began in the fall of 2022, and the first patient was enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in quarter 1 of 2025. Publication of complete results and data from this study is expected in 2026.ConclusionsThis project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF.Trial registrationClinicalTrials.gov NCT05056129; https://clinicaltrials.gov/ct2/show/NCT05056129.International registered report identifier (irrid)DERR1-10.2196/45801.

Dataset Information

Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT).

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Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT).

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