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Supporting women's health outcomes after breast cancer treatment comparing a text message intervention to usual care: the EMPOWER-SMS randomised clinical trial.

ABSTRACT: The aim of this study is to evaluate the efficacy, feasibility and acceptability of a co-designed lifestyle-focused text message intervention (EMPOWER-SMS) for breast cancer survivors' self-efficacy, quality of life (QOL), mental (anxiety, depression, stress) and physical (endocrine therapy medication adherence, physical activity, BMI) health. Single-blind randomised controlled trial (1:1) comparing EMPOWER-SMS to usual care at 6-months (intention-to-treat). public Breast Cancer Institute (Sydney, Australia). adult (> 18 years) females, < 18-months post-active breast cancer treatment (stage I-III), owned a mobile phone, written informed consent. Self-Efficacy for Managing Chronic Disease Scale at 6 months. Process data: message delivery analytics, cost, and post-intervention survey. Participants (N = 160; mean age ± SD 55.1 ± 11.1 years) were recruited 29th-March-2019 to 7th-May-2020 and randomised (n = 80 EMPOWER-SMS: n = 80 control). Baseline mean self-efficacy was high (I: 7.1 [95%CI 6.6, 7.5], C: 7.4 [7, 7.8]). Six-month follow-up: no significant differences between groups for self-efficacy (I: 7.6 [7.3, 7.9], C: 7.6 [7.3, 7.9], adjusted mean difference 0 (95%CI 0.4, 0.4), QOL, mental health, physical activity, or BMI. Significantly less EMPOWER-SMS participants missed ≥ 1 endocrine therapy medication doses compared to control (I: 3/42[7.1%], C: 8/47[17.0%], Adjusted RR 0.13 [95%CI 0.02, 0.91]). Text messages were delivered successfully (7925/8061, 98.3%), costing $13.62USD/participant. Participants strongly/agreed EMPOWER-SMS was easy-to-understand (64/64; 100%), useful (58/64; 90.6%), motivating for lifestyle change (43/64; 67.2%) and medication adherence (22/46; 47.8%). EMPOWER-SMS was feasible, inexpensive, acceptable for delivering health information to breast cancer survivors between medical appointments, with minor improvements in medication adherence. Text messages offer a feasible strategy for continuity-of-care between medical appointments.

SUBMITTER: Singleton AC

PROVIDER: S-EPMC9034445 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.

Project description:BackgroundImproved access to sexual and reproductive health (SRH) services and information is essential for supporting adolescents and youth in making informed decisions and optimizing each young person's outcomes related to their SRH, health and well-being and countries' current and future social and economic development. Mobile phones offer opportunities for young people to privately access SRH content and to be linked to SRH services. The objective of this study was to develop the content for an SMS (short message service or "text message") platform jointly with adolescents and youth in three regions in Peru (Lima, Ayacucho and Loreto) as part of the ARMADILLO (Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes) Study.MethodsContent development was done in three stages. During Stage 1, we held community consultations with 13-17 year old adolescents, 18-24 year old youth and professionals who work with young people through the education and health sectors ("adult advisers") to identify and rate SRH topics of interest through group free- and guided-brainstorming activities and an individual written sharing activity. During Stage 2, the team developed the preliminary domains, sub-domains and content for the SMS platform. During Stage 3, we held focus groups with adolescents to validate the SMS content, including both individual scoring of and group feedback for each SMS. Group feedback asked about their general impressions and understanding and their thoughts about the language and usefulness of the SMS.ResultsA total of 172 adolescents and youth ages 13-24 and 20 adult advisers participated. Adolescents and youth brainstormed and rated SRH topics and sub-topics that led to the initial structure for the SMS platform, with 9 domains, 25 sub-domains and 146 draft SMS. Adolescents provided high scores for the SMS, with all sub-domains receiving average scores of 3.0 or higher (out of 4.0) for the SMS included. Adolescents also provided suggestions to optimize content, including improvements to unclear messages, resulting in SMS with adolescent-friendly content in simple, straightforward language. This process also revealed that adolescents lacked knowledge and had misconceptions related to contraceptive methods.ConclusionThis study details the systematic process used to develop relevant and accessible SRH information through a participatory approach. We document critical information about what young people know and how they think, enabling us to understand their perspective and literally speak their language. Results also provide future directions for programmatic, research and policy efforts with young people, in particular around gender norms, interpersonal violence, and access to SRH information and services, in similar settings.

Project description:BackgroundExtending contact with participants after the end of an initial weight loss intervention has been shown to lead to maintained weight loss and related behavioral change. Mobile phone text messaging (short message service, SMS) offers a low-cost and efficacious method to deliver extended contact. In this rapidly developing area, formative work is required to understand user perspectives of text message technology. An extended contact intervention delivered by text messages following an initial telephone-delivered weight loss intervention in breast cancer survivors provided this opportunity.ObjectiveThe aim of this study was to qualitatively explore women's perceptions of participation in an extended contact intervention using text messaging to support long-term weight loss, physical activity, and dietary behavioral change.MethodsFollowing the end of an initial 6-month randomized controlled trial of a telephone-delivered weight loss intervention (versus usual care), participants received a 6-month extended contact intervention via tailored text messages. Participant perceptions of the different types of text messages, the content, tailoring, timing, and frequency of the text messages, and the length of the intervention were assessed through semistructured interviews conducted after the extended contact intervention. The interviews were transcribed verbatim and analyzed with key themes identified.ResultsParticipants (n=27) were a mean age of 56.0 years (SD 7.8) and mean body mass index of 30.4 kg/m2 (SD 4.2) and were at a mean of 16.1 months (SD 3.1) postdiagnosis at study baseline. Participants perceived the text messages to be useful behavioral prompts and felt the messages kept them accountable to their behavioral change goals. The individual tailoring of the text message content and schedules was a key to the acceptability of the messages; however, some women preferred the support and real-time discussion via telephone calls (during the initial intervention) compared with the text messages (during the extended contact intervention).ConclusionsText message support was perceived as acceptable for the majority of women as a way of extending intervention contact for weight loss and behavioral maintenance. Text messages supported the maintenance of healthy behaviors established in the intervention phase and kept the women accountable to their goals. A combination of telephone calls and text message support was suggested as a more acceptable option for some of the women for an extended contact intervention.

Project description:BackgroundHealth care providers are increasingly screening patients for unmet social needs (eg, food, housing, transportation, and social isolation) and referring patients to relevant community-based resources and social services. Patients' connection to referred services is often low, however, suggesting the need for additional support to facilitate engagement with resources. SMS text messaging presents an opportunity to address barriers related to contacting resources in an accessible, scalable, and low-cost manner.ObjectiveIn this multi-methods pilot study, we aim to develop an automated SMS text message-based intervention to promote patient connection to referred social needs resources within 2 weeks of the initial referral and to evaluate its feasibility and patient acceptability. This protocol describes the intervention, conceptual underpinnings, study design, and evaluation plan to provide a detailed illustration of how SMS technology can complement current social needs screening and referral practice patterns without disrupting care.MethodsFor this pilot prospective cohort study, this SMS text message-based intervention augments an existing social needs screening, referral, and navigation program at a federally qualified health center. Patients who received at least one referral for any identified unmet social need are sent 2 rounds of SMS messages over 2 weeks. The first round consists of 5-10 messages that deliver descriptions of and contact information for the referred resources. The second round consists of 2 messages that offer a brief reminder to contact the resources. Participants will evaluate the intervention via a survey and a semistructured interview, informed by an adapted technology acceptance model. Rapid qualitative and thematic analysis will be used to extract themes from the responses. Primary outcomes are implementation feasibility and patient acceptability. Secondary outcomes relate to intervention effectiveness: self-reported attempt to connect and successful connection to referred resources 2 weeks after the initial referral encounter.ResultsThe study received regulatory approval in May 2021, and we anticipate enrolling 15-20 participants for this initial pilot.ConclusionsThis protocol presents detailed implementation methods about a novel automated SMS intervention for social care integration within primary care. By sharing the study protocol early, we intend to facilitate the development and adoption of similar tools across different clinical settings, as more health care providers seek to address the unmet social needs of patients. Study findings will provide practical insights into the design and implementation of SMS text message-based interventions to improve social and medical care coordination.International registered report identifier (irrid)DERR1-10.2196/37316.

Project description:BACKGROUND:Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop. METHODS/DESIGN:This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size, and held on a secure server. All participants receive a National Health Service (NHS) leaflet aimed at helping them to stop smoking. Intervention group women also receive the 12-week MiQuit programme of tailored, supportive, interactive text message, self-help cessation support. Women are followed up by telephone 4 weeks after randomisation and at 36 weeks gestation. The study aims to recruit 400 women, and with this sample we will be able to estimate trial centres' recruitment rates to within +/-1% (margin of error?=?half width of 95% confidence interval); individual trial groups' ascertainment of rates for smoking outcomes between 4 weeks after randomisation until approximately 36 weeks gestation to within +/-4%, and across both groups, the combined cessation rate at 36 weeks +/-3%. DISCUSSION:Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02043509 Registered 14 January 2014.

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Supporting women's health outcomes after breast cancer treatment comparing a text message intervention to usual care: the EMPOWER-SMS randomised clinical trial.

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