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PURPOSE: Physical activity research among patients with metastatic breast cancer (MBC) is limited. This study examined the feasibility and potential benefits of Fit2ThriveMB, a tailored mHealth intervention. METHODS: Insufficiently active individuals with MBC (n = 49) were randomized 1:1 to Fit2ThriveMB (Fit2ThriveMB app, Fitbit, and weekly coaching calls) or Healthy Lifestyle attention control (Cancer.Net app and weekly calls) for 12 weeks. Fit2ThriveMB aimed to increase daily steps via an algorithm tailored to daily symptom rating and step goal attainment. The primary outcome was feasibility defined as ≥ 80% completion rate. Secondary feasibility metrics included meeting daily step goal and wearing the Fitbit ≥ 70% of study days, fidelity, adherence to intervention features and safety. Secondary outcomes included physical activity, sedentary time, patient reported outcomes (PROs), health-related quality of life (QOL) and social cognitive theory constructs. A subsample (n = 25) completed functional performance tests via video conferencing. RESULTS: The completion rate was 98% (n = 1 died). No related adverse events were reported. Fit2ThriveMB participants (n = 24) wore the Fitbit 92.7%, met their step goal 53.1%, set a step goal 84.6% and used the app 94.1% of 84 study days. Intent-to-treat analyses indicated trends toward improvements in activity, QOL, and some PROs, social cognitive theory constructs, and functional performance tests favoring the Fit2ThriveMB group. Significant effects favoring Fit2ThriveMB were observed for self-efficacy and goal-setting. However, some PROs and functional performance improvements favored the control group (p-values > 0.05). CONCLUSIONS: Fit2ThriveMB is feasible and safe for patients with MBC and warrants further evaluation in randomized controlled trials with larger sample sizes. Registration Clinicaltrials.gov NCT04129346, https://clinicaltrials.gov/ct2/show/NCT04129346.
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Increased moderate and vigorous physical activity (MVPA) is associated with better health outcomes in breast cancer survivors; yet, most are insufficiently active. Smartphone applications (apps) to promote MVPA have high scalability potential, but few evidence-based apps exist. The purpose is to describe the testing and usability of Fit2Thrive, a MVPA promotion app for breast cancer survivors. A user-centered, iterative design process was utilized on three independent groups of participants. Two groups of breast cancer survivors (group 1 n = 8; group 2: n = 14) performed app usability field testing by interacting with the app for ≥3 days in a free-living environment. App refinements occurred following each field test. The Post-Study System Usability Questionnaire (PSSUQ) and the User Version Mobile Application Rating Scale (uMARS) assessed app usability and quality on a 7- and 5-point scale, respectively, and women provided qualitative written feedback. A third group (n = 15) rated potential app notification content. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed using a directed content analysis. The PSSUQ app usability score (M1= 3.8; SD = 1.4 vs. M2= 3.2; SD = 1.1; lower scores are better) and uMARS app quality score (M1 = 3.4; SD = 1.3 vs. M2= 3.4; SD = 0.6; higher scores are better) appeared to improve in Field Test 2. Group 1 participants identified app "clunkiness," whereas group 2 participants identified issues with error messaging/functionality. Group 3 "liked" 53% of the self-monitoring, 71% of the entry reminder, 60% of the motivational, and 70% of the goal accomplishment notifications. Breast cancer survivors indicated that the Fit2Thrive app was acceptable and participants were able to use the app. Future work will test the efficacy of this app to increase MVPA.
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Neoplasias de la Mama , Supervivientes de Cáncer , Aplicaciones Móviles , Ejercicio Físico , Femenino , Humanos , Teléfono InteligenteRESUMEN
BACKGROUND: The benefits of moderate to vigorous physical activity (MVPA) for breast cancer survivors are well established. However, most are insufficiently active. Fit2Thrive used the Multiphase Optimization Strategy methodology to determine the effect of 5 intervention components on MVPA in this population. METHODS: Two hundred sixty-nine participants (mean age, 52.5 years; SD, 9.9 years) received a core intervention (the Fit2Thrive self-monitoring app and Fitbit) and were randomly assigned to 5 intervention components set to on/off in a full factorial experiment: support calls, deluxe app, buddy, online gym, and text messages. The intervention was delivered over 12 weeks with a 12-week follow-up. MVPA was measured via accelerometry at the baseline (T1), at 12 weeks (T2), and at 24 weeks (T3). The main effects and interaction effects at each time point were examined for all components. RESULTS: Trial retention was high: 91.8% had valid accelerometer data at T2 or T3. Across all conditions, there were significant increases in MVPA (+53.6 min/wk; P < .001) and in the proportion of survivors meeting MVPA guidelines (+22.3%; P < .001) at T2 that were maintained but attenuated at T3 (MVPA, +24.6 min/wk; P < .001; meeting guidelines, +12.6%; P < .001). No individual components significantly improved MVPA, although increases were greater for the on level versus the off level for support calls, buddy, and text messages at T2 and T3. CONCLUSIONS: The Fit2Thrive core intervention (the self-monitoring app and Fitbit) is promising for increasing MVPA in breast cancer survivors, but the components provided no additional increases in MVPA. Future research should evaluate the core intervention in a randomized trial and determine what components optimize MVPA behaviors in breast cancer survivors.
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Neoplasias de la Mama , Supervivientes de Cáncer , Ejercicio Físico , Acelerometría , Adulto , Neoplasias de la Mama/rehabilitación , Femenino , Humanos , Persona de Mediana Edad , Aplicaciones Móviles , Monitoreo Ambulatorio , Autocuidado , TecnologíaRESUMEN
OBJECTIVE: Although physical activity is associated with better health outcomes in breast cancer survivors (BCS), activity often declines during cancer treatment. Social cognitive theory (SCT) constructs have been associated with physical activity in post-treatment BCS, but little is known about the relation between these constructs and physical activity during chemotherapy. METHODS: BCS (n = 67; Mage = 48.6 [SD = 10.3]) undergoing chemotherapy wore accelerometers and completed prompts in the morning and at night assessing same-day and next-day exercise self-efficacy, physical and psychological outcome expectations, and goal-setting for 10 consecutive days (3 days pre-, day of, and 6 days post-chemotherapy dose) at three time points (beginning, middle, and end of chemotherapy). Separate mixed models assessed between- and within-person associations of each of the SCT constructs associations with same- and next-day moderate to vigorous physical activity (MVPA) and light physical activity (LPA), independently. RESULTS: Within-person differences in all SCT variables were statistically significantly related to same-day MVPA (p's < 0.001) and LPA (p's < 0.001). Every one-point increase in SCT construct related to an increase in MVPA ranging from (a) 3.70 (self-efficacy) to 8.02 (physical outcome expectations) minute increase in MVPA and (b) 12.72 (self-efficacy) to 20.38 (physical outcome expectations) increase in LPA that day. No same-day between-person effects nor any next-day effects were significant. CONCLUSION: MVPA and LPA were related to same-day within-person differences in SCT variables. Interventions targeted at increasing or mitigating chemotherapy-related declines in daily within-person changes in SCT constructs could help to increase physical activity among BCS during chemotherapy.
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Neoplasias de la Mama , Supervivientes de Cáncer , Neoplasias de la Mama/tratamiento farmacológico , Supervivientes de Cáncer/psicología , Cognición , Ejercicio Físico/psicología , Femenino , Humanos , Persona de Mediana Edad , AutoeficaciaRESUMEN
BACKGROUND: Increased incidence and life expectancy have resulted in a growing population of patients with metastatic breast cancer, and these patients experience high rates of morbidity and premature mortality. Increased physical activity (PA) is consistently associated with improved health and disease outcomes among early-stage survivors. However, there is a paucity of research on PA in patients with metastatic breast cancer, and existing PA interventions have exhibited low feasibility because of their focus on intense PA and/or requirement of on-site visits. Mobile health (mHealth)-based PA interventions may be particularly useful for patients with metastatic breast cancer because they allow for remote monitoring, which facilitates individual tailoring of PA recommendations to patients' abilities and may minimize participant burden. However, no studies have examined mHealth PA interventions in patients with metastatic breast cancer. OBJECTIVE: We aim to address these critical research gaps by testing a highly tailored technology-based intervention to promote PA of any intensity (ie, light, moderate, or vigorous) by increasing daily steps in patients with metastatic breast cancer. The primary aim of this study is to test the feasibility and acceptability of the Fit2ThriveMB intervention. We will also examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom burden, quality of life, and functional performance. METHODS: The Fit2ThriveMB trial is a two-arm pilot randomized controlled trial that will compare the effects of a smartphone-delivered, home-based PA intervention and an attention-control education condition on PA and quality of life in low-active female patients with metastatic breast cancer. A subsample (n=25) will also complete functional performance measures. This innovative trial will recruit 50 participants who will be randomized into the study's intervention or control arm. The intervention will last 12 weeks. The Fit2ThriveMB intervention consists of a Fitbit, coaching calls, and the Fit2ThriveMB smartphone app that provides self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app notifications, and a group message board. Assessments will occur at baseline and post intervention. RESULTS: The Fit2ThriveMB study is ongoing. Data collection ended in February 2021. CONCLUSIONS: Data from this study will provide the preliminary effect sizes needed to assemble an intervention that is to be evaluated in a fully powered trial. In addition, these data will provide essential evidence to support the feasibility and acceptability of using a technology-based PA promotion intervention, a scalable strategy that could be easily integrated into care, among patients with metastatic breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT04129346; https://clinicaltrials.gov/ct2/show/NCT04129346. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24254.
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BACKGROUND: Increased activity is beneficial during chemotherapy, but treatment-related symptoms may be a barrier. This study examines the relationship between daily fluctuations in symptoms and activity during chemotherapy. METHODS: Women undergoing chemotherapy for breast cancer [n = 67; M age = 48.6 (SD = 10.3)] wore an accelerometer 24 hours/day and received four text prompts/day to rate symptoms for 10 consecutive days at the beginning, middle, and end of chemotherapy. Mixed-effects models were used to examine the between and within-person relationships between symptom ratings on a given day and moderate to vigorous physical activity (MVPA) and light physical activity (LPA) on that day and the following day controlling for relevant covariates and using the Bonferroni correction for multiple comparisons. RESULTS: For MVPA and LPA, within-person associations were statistically significant for same day affect, fatigue, pain, walking, activities of daily living (ADL) physical function, and cognitive function. Previous day anxiety was associated with next day LPA. Every one point worse symptom rating than an individual's overall average was associated with: (i) between 1.49 (pain) and 4.94 (fatigue) minutes less MVPA and between 4.48 (pain) and 24.72 (ADL physical function) minutes less LPA that day, and (ii) 11.28 minutes less LPA the next day. No between-person effects were significant for MVPA or LPA. CONCLUSIONS: Daily within-person variations in symptoms were associated with MVPA and LPA during chemotherapy for breast cancer. IMPACT: Future work should explore relationships between symptoms and activity further and identify whether tailoring to symptoms enhances efficacy of physical activity promotion interventions during chemotherapy.
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Acelerometría/métodos , Neoplasias de la Mama/tratamiento farmacológico , Ejercicio Físico/fisiología , Femenino , Humanos , Estudios Longitudinales , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Bone marrow mesenchymal stem cell (BMSC)-derived small extracellular vesicles (sEV) but not fibroblast sEV provide retinal ganglion cell (RGC) neuroprotection both in vitro and in vivo, with miRNAs playing an essential role. More than 40 miRNAs were more abundant in BMSC-sEV than in fibroblast-sEV. The purpose of this study was to test the in vitro and in vivo neuroprotective and axogenic properties of six candidate miRNAs (miR-26a, miR-17, miR-30c-2, miR-92a, miR-292, and miR-182) that were more abundant in BMSC-sEV than in fibroblast-sEV. Adeno-associated virus 2 (AAV2) expressing a combination of three of the above candidate miRNAs were added to heterogenous adult rat retinal cultures or intravitreally injected into rat eyes one week before optic nerve crush (ONC) injury. Survival and neuritogenesis of ßIII-tubulin+ RGCs was assessed in vitro, as well as the survival of RBPMS+ RGCs and regeneration of their axons in vivo. Retinal nerve fiber layer thickness (RNFL) was measured to assess axonal density whereas positive scotopic threshold response electroretinography amplitudes provided a readout of RGC function. Qualitative retinal expression of PTEN, a target of several of the above miRNAs, was used to confirm successful miRNA activity. AAV2 reliably transduced RGCs in vitro and in vivo. Viral delivery of miRNAs in vitro showed a trend towards neuroprotection but remained insignificant. Delivery of selected combinations of miRNAs (miR-17-5p, miR-30c-2 and miR-92a; miR-92a, miR-292 and miR-182) before ONC provided significant therapeutic benefits according to the above measurable endpoints. However, no single miRNA appeared to be responsible for the effects observed, whilst positive effects observed appeared to coincide with successful qualitative reduction in PTEN immunofluorescence in the retina. Viral delivery of miRNAs provides a possible neuroprotective strategy for injured RGCs that is conducive to therapeutic manipulation.