Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial.
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ABSTRACT:
SUBMITTER: Graetz I
PROVIDER: S-EPMC6054536 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
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Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial.
Graetz Ilana I McKillop Caitlin N CN Stepanski Edward E Vidal Gregory A GA Anderson Janeane N JN Schwartzberg Lee S LS
Journal of cancer survivorship : research and practice 20180228 4
<h4>Purpose</h4>For postmenopausal women with hormone receptor-positive breast cancer, long-term use of aromatase inhibitors (AIs) significantly reduces the risk of cancer recurrence and improves survival. Still, many patients are nonadherent due to adverse side effects. We conducted a pilot randomized controlled trial to test the use of a web-based application (app) designed with and without weekly reminders for patients to report real-time symptoms and AI use outside of clinic visits with buil ...[more]
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Project description:BackgroundPatients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient's quality of life.ObjectiveThis study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored.MethodsThis study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project.ResultsAt the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews.ConclusionsThis protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect.Trial registrationClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830.International registered report identifier (irrid)DERR1-10.2196/49549.
| S-EPMC10905362 | biostudies-literature
Project description:PURPOSE:Aromatase inhibitors (AIs) are a potentially life-saving treatment for breast cancer survivors, yet poor adherence to treatment is a prevalent problem. A common adverse effect of AI treatment is arthralgia, which is identified by survivors as a major reason for treatment discontinuation. Women who experience arthralgia on AIs often report feeling they have aged rapidly while on the treatment. In the present study, we examined whether arthralgia-associated ageing perceptions predicted non-adherence. PATIENTS AND METHODS:We conducted a prospective cohort study among women with stage I-III breast cancer, who were on an AI and completed the Penn Arthralgia Aging Scale within 2 years of AI initiation. Adherence data were abstracted from medical charts by trained raters. Cox proportional hazard analysis was used to determine the relationship between ageing perceptions and time to non-adherence. All analyses included adjustments for joint pain severity. RESULTS:Among 509 participants, 144 (28.3%) were non-adherent. As hypothesised, women with high levels of ageing perceptions were at greater risk of non-adherence than women with low levels of ageing perceptions (adjusted hazard ratio [HR], 1.71; 95% confidence interval [CI], 1.10-2.67; p = .02). High levels of depressive symptoms were also uniquely associated with increased risk of non-adherence (adjusted HR, 1.63; 95% CI, 1.03-2.59; p = .04). CONCLUSION:Perceptions of ageing related to arthralgia and depressive symptoms predicted non-adherence to AIs. These findings suggest that interventions that address negative beliefs about ageing due to AI-related arthralgia and depressive mood can potentially improve rates of adherence to AIs.
| S-EPMC5803454 | biostudies-other
Project description:BackgroundHypertension control remains a significant challenge in reducing the cardiovascular disease burden worldwide. Community peer-support groups have been identified as a promising strategy to improve medication adherence and blood pressure (BP) control.ObjectivesThe study aimed to evaluate the feasibility and impact of adherence clubs to improve BP control in Southeast Nigeria.MethodsThis was a mixed-methods research involving a formative (pre-implementation) research, pilot study and process evaluation. Hypertensive patients in two communities were recruited into peer-support adherence clubs under the leadership of role-model patients to motivate and facilitate medication adherence, BP monitoring, and monthly medication delivery for six months. The primary outcome was medication adherence measured using visual analogue scale (VAS), with BP level at six months as a key secondary outcome.ResultsWe recruited a total of 104 participants. The mean age was 56.8 (SD-10.7) years, 72 (69.2%) were women, mean BP was 146.7 (SD-20.1)/86.9 (SD-11.2) mmHg, and the mean percentage of medication adherence on the VAS was 41.4% (SD-11.9%). At six months, 67 patients were assessed; self-reported adherence on the VAS increased to 57.3% (SD-25.3%) (mean difference between baseline and follow-up of 15.5%, p < 0.0001), while the mean BP decreased to 132.3 (SD-22.0)/82.9 (SD-12.2) mmHg (mean difference of 13.0 mmHg in systolic BP, p < 0.0001 and of 3.6 mmHg in diastolic BP, p = 0.02). Five in-depth interviews and four focus groups discussions were conducted as part of the qualitative analyses of the study. The participants saw hypertension as a big issue, with many unaware of the diagnosis, and they accepted the CLUBMEDS differential service delivery (DSD) model concept in hypertension.ConclusionsThe study demonstrates that the implementation of adherence clubs for hypertension control is feasible and led to a statistically significant and clinically meaningful improvement in self-reported medication adherence, resulting in BP reduction. Upscaling the intervention may be needed to confirm these findings.
| S-EPMC8932363 | biostudies-literature
Project description:ObjectiveTo examine the feasibility and usability of EnergyPoints™, an innovative mobile health app that teaches and guides people with cancer to implement daily acupressure to self-manage their fatigue and sleep disturbances.Methods and interventionThe study used an integrated agile, human-centered approach. Adults (age 18 years and over) with cancer experiencing at least moderate fatigue, and living in the Greater New York City community, were recruited from social media, patient advocacy groups, and referrals. Twenty participants (in 3 sprints of 3, 5, and 12) were video-recorded thinking aloud while using the app for the first time. They then used the app at home to self-administer acupressure (twice daily for 1 week) while continuously wearing a fitness tracker. Each participant completed an exit interview and modified Computer System Usability Questionnaire post-participation.ResultsParticipants were ages 40 to 76 years and 65% female; 65% were non-Hispanic white. Mean pass rates per ritual exceeded 80%. Users completed (totally or partially) greater than 90% of stimulating acupressure and 70% of relaxing acupressure rituals. Sprint 3 SPs totally completed at least 1 ritual 87% of the time. The majority agreed or strongly agreed the app was easy to use (90%), easy to learn (85%), easy to understand (75%), and effective in helping perform self-acupressure (85%). In an analysis of ease of completing 5 key tasks, all successfully completed the tasks; 3 users required some assistance. Of 654 usability statements, those coded as personal experience/context (197), content related to acupressure learning (105), and content related to the onboarding/profile (71) were most frequent. The design team integrated recommendations into the app before the next sprint.ConclusionsFindings supported feasibility and usability, as well as acceptability, and led to significant alterations and improvements. EnergyPoints™ offers an opportunity to mainstream acupressure and help cancer survivors self-manage their symptoms.
| S-EPMC10826379 | biostudies-literature
Project description:PurposeThis study aimed to evaluate the preliminary effectiveness of an educational intervention using a web-app to improve knowledge of breast cancer risk factors and symptoms and adherence to healthy eating and physical activity among women without breast cancer diagnosis in Asturias (Spain).MethodsA pragmatic randomized pilot trial was conducted to evaluate the impact of a web-app-based intervention for women without breast cancer diagnosis. Women in the intervention group participated in a 6-month intervention web-app based on the Behaviour Change Wheel Model. The web-app includes information about breast cancer risk factors, early detection, physical activity and diet.ResultsTwo hundred and eighty-fifth women aged 25-50 were invited to join the study. Two hundred and twenty-four were randomly assigned to either the intervention group (IG = 134) or control group (CG = 90) according to their place of residence. Adherence among women in the IG increased significantly from pre- to post-intervention for eight of the 12 healthy behaviors and for the identification of six risk factors and six symptoms compared to women in the CG and, among whom adherence only increased for two behaviors, the identification of one risk factor and 0 symptoms. The intervention significantly improved the mean number of risk factors + 1.06 (p < 0.001) and symptoms + 1.18 (p < 0.001) identified by women in the IG.ConclusionsThe preliminary results of this study suggest that an educational intervention using a web-app and based on the Behaviour Change Wheel model could be useful to improve knowledge of breast cancer risk factors and symptoms and to improve adherence to a healthy diet and physical activity in women without a previous breast cancer diagnosis.
| S-EPMC9877062 | biostudies-literature
Project description:BackgroundDuring the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit.ObjectivesThe primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention.MethodsWe used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception.ResultsThe median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06).ConclusionsWe have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system.Trial registrationClinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk).
| S-EPMC5654734 | biostudies-literature
Project description:BackgroundLong-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence.MethodsIn this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an "App" group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an "App+Feedback" group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a "Usual Care" group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence.DiscussionA successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient care experience.Trial registrationNCT03592771. Prospectively registered on July 19, 2018.
| S-EPMC6924011 | biostudies-literature
Project description:Nonadherence to hormonal therapy is common and is associated with increased copayment amount. We investigated the change in adherence after the introduction of generic aromatase inhibitors (AIs) in 2010. Using deidentified pharmacy and claims data from OptumInsight, we identified women older than 50 years on brand-name AIs (BAIs) and/or generic AIs (GAIs) for early breast cancer between January 1, 2007 and December 31, 2012. Clinical, demographic, and financial variables were evaluated. Adherence was defined as a medication possession ratio (MPR) 80% or greater. We identified 5511 women, 2815 (51.1%) on BAI, 1411 (25.6%) on GAI, and 1285 (23.3%) who switched from BAI to GAI. The median 30-day copayment was higher for BAI ($33.3) than for GAI ($9.04). In a multivariable Cox-proportional hazard analysis, women who took GAI were less likely to discontinue therapy (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.57 to 0.84) compared with BAI. Discontinuation was positively associated with a higher monthly copayment of $15 to $30 (HR = 1.21, 95% CI = 1.01 to 1.44) and more than $30 (HR = 1.49, 95% CI = 1.23 to 1.80) compared with less than $15. In a multivariable logistic regression analysis, adherence (medication possession ratio ≥ 80%) was positively associated with GAI use (odds ratio = 1.53, 95% CI = 1.22 to 1.91) compared with BAI and inversely associated with increased monthly copayment. In addition, adherence was associated with a high annual income of more than $100k/year (odds ratio = 1.58, 95% CI = 1.17 to 2.11). Higher prescription copayment amount was associated with nonadherence and discontinuation of AIs. After controlling for copayment, discontinuation was higher and adherence was lower with Brand AIs. Because nonadherence is associated with worse survival, efforts should be directed towards reducing out-of-pocket costs for these life-saving medications.
| S-EPMC4271034 | biostudies-literature
Project description:BackgroundThe efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations.ObjectiveThis study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes.MethodsWe block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records.ResultsA total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication.ConclusionsOur feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.
| S-EPMC6746066 | biostudies-literature
Project description:BackgroundSupportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application that facilitates symptom screening and access to supportive care clinical practice guidelines (CPGs) for children and adolescents receiving cancer treatments. Objective was to develop SPARK family member web pages for pediatric patient family members accessing: (1) proxy symptom screening and symptom reports, and (2) care recommendations for symptom management based on CPGs.MethodsSPARK family member web pages were developed and included access to symptom screening and care recommendations sections. Care recommendations for fatigue and mucositis were created. These were iteratively refined based upon cognitive interviews with English-speaking family members ≥16 years of age until less than two participants incorrectly understood sections as adjudicated by two independent raters.ResultsA total of 100 family members were enrolled who evaluated the SPARK family member web pages (n = 40), fatigue care recommendation (n = 30) and mucositis prevention care recommendation (n = 30). Among the last 10 participants, none said that the SPARK family member web pages were hard or very hard to use, one incorrectly understood one web page, none said either care recommendation was hard to understand and none were incorrect in their understanding of the care recommendations.ConclusionsWe successfully developed SPARK web pages for use by family members of pediatric patients receiving cancer treatments. We also developed a process for translating CPG recommendations designed for healthcare professionals to lay language. The utility of SPARK family member web pages after clinical implementation could be a focus for future research.
| S-EPMC7519510 | biostudies-literature