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Background: Opt2Move is a theory-guided moderate and vigorous physical activity (MVPA) promotion trial that uses multiphase optimization strategy (MOST) methodology to evaluate the individual and combined effects of four intervention components in a full factorial experiment among young adult cancer survivors (YACS; N = 304). All participants will receive the core mHealth MVPA intervention, which includes a Fitbit and standard self-monitoring Opt2Move smartphone application. YACS will be randomized to one of 16 conditions to receive between zero and four additional components each with two levels (yes v. no): E-Coach, buddy, general mindfulness, and MVPA-specific mindfulness. Objective: The primary aim is to determine the individual and combined effects of the components on MVPA post-intervention (12-weeks) and at 24-week follow-up. The secondary aim is to examine how changes in MVPA are associated with patient-reported outcomes, light-intensity activity, sedentary time, and sleep duration and quality. Potential mediators and moderators of component effects will also be examined. Results: Results will support the selection of a package of intervention components optimized to maximize MVPA to be tested in a randomized controlled trial. Conclusion: Opt2Move represents the first systematic effort to use MOST to design an optimized, scalable mHealth MVPA intervention for YACS and will lead to an improved understanding of how to effectively change YACS' MVPA and ultimately, improve health and disease outcomes.
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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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BACKGROUND: Moderate to vigorous physical activity (MVPA) interventions improve patient-reported outcomes (PROs) of physical and psychological health among breast cancer survivors (BCS); however, the effects of specific intervention components on PROs are unknown. PURPOSE: To use the Multiphase Optimization Strategy (MOST) to examine overall effects of the Fit2Thrive MVPA promotion intervention on PROs in BCS and explore whether there are intervention component-specific effects on PROs. METHODS: Physically inactive BCS [n = 269; Mage = 52.5 (SD = 9.9)] received a core intervention (Fitbit + Fit2Thrive smartphone app) and were randomly assigned to one of 32 conditions in a full factorial experiment of five components ("on" vs. "off"): (i) support calls, (ii) deluxe app, (iii) text messages, (iv) online gym, and (v) buddy. Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires assessed anxiety, depression, fatigue, physical functioning, sleep disturbance and sleep-related impairment at baseline, post-intervention (12-week), and 24-week follow-up. Main effects for all components at each time point were examined using an intention to treat mixed-effects model. RESULTS: All PROMIS measures except sleep disturbance significantly improved (p's < .008 for all) from baseline to 12-weeks. Effects were maintained at 24-weeks. The "on" level of each component did not result in significantly greater improvements on any PROMIS measure compared to the "off" level. CONCLUSIONS: Participation in Fit2Thrive was associated with improved PROs in BCS, but improvements did not differ for "on" vs. "off" levels for any component tested. The low-resource Fit2Thrive core intervention is a potential strategy to improve PROs among BCS. Future studies should test the core in an RCT and examine various intervention component effects in BCS with clinically elevated PROs.
Assuntos
Neoplasias da Mama , Sobreviventes de Câncer , Humanos , Feminino , Neoplasias da Mama/terapia , Sobreviventes de Câncer/psicologia , Sobreviventes/psicologia , Ansiedade , Medidas de Resultados Relatados pelo PacienteRESUMO
Despite the known benefits of moderate-to-vigorous physical activity (MVPA) for breast and endometrial cancer survivors, most are insufficiently active, interventions response is heterogeneous, and MVPA programming integration into cancer care is limited. A stepped care approach, in which the least resource-intensive intervention is delivered first and additional components are added based on individual response, is one strategy to enhance uptake of physical activity programming. However, the most effective intervention augmentation strategies are unknown. In this singly randomized trial of post-treatment, inactive breast and endometrial cancer survivors (n = 323), participants receive a minimal intervention including a Fitbit linked with their clinic's patient portal and, in turn, the electronic health record (EHR) with weekly feedback delivered via the portal. MVPA progress summaries are sent to participants' oncology team via the EHR. MVPA adherence is evaluated at 4, 8, 12, 16 and 20 weeks; non-responders (those meeting ≤80% of the MVPA goal over previous 4 weeks) at each timepoint are randomized once for the remainder of the 24-week intervention to one of two "step-up" conditions: (1) online gym or (2) coaching calls, while responders continue with the minimal Fitbit+EHR intervention. The primary outcome is ActiGraph-measured MVPA at 24 and 48 weeks. Secondary outcomes include symptom burden and functional performance at 24 and 48 weeks. This trial will inform development of an effective, scalable, and tailored intervention for survivors by identifying non-responders and providing them with the intervention augmentations necessary to increase MVPA and improve health outcomes. Clinical Trials Registration # NCT04262180.