Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial.

INTRODUCTION: Type 2 diabetes is prevalent among US adults. Lifestyle interventions that modify health behaviours prevent or delay progression to diabetes among individuals at high risk. Despite the well-documented influence of individuals' social context on their health, evidence-based type 2 diabetes prevention interventions do not systematically incorporate participants' romantic partners. Involving partners of individuals at high risk for type 2 diabetes in primary prevention may improve engagement and outcomes of programmes. The randomised pilot trial protocol described in this manuscript will evaluate a couple-based lifestyle intervention to prevent type 2 diabetes. The objective of the trial is to describe the feasibility of the couple-based intervention and the study protocol to guide planning of a definitive randomised clinical trial (RCT). METHODS AND ANALYSIS: We used community-based participatory research principles to adapt an individual diabetes prevention curriculum for delivery to couples. This parallel two-arm pilot study will include 12 romantic couples in which at least one partner (ie, 'target individual') is at risk for type 2 diabetes. Couples will be randomised to either the 2021 version of the CDC's PreventT2 curriculum designed for delivery to individuals (six couples), or PreventT2 Together, the adapted couple-based curriculum (six couples). Participants and interventionists will be unblinded, but research nurses collecting data will be blinded to treatment allocation. Feasibility of the couple-based intervention and the study protocol will be assessed using both quantitative and qualitative measures. ETHICS AND DISSEMINATION: This study has been approved by the University of Utah IRB (#143079). Findings will be shared with researchers through publications and presentations. We will collaborate with community partners to determine the optimal strategy for communicating findings to community members. Results will inform a subsequent definitive RCT. TRIAL REGISTRATION NUMBER: NCT05695170.

Longitudinal Sedentary Time and Symptoms in Breast Cancer Patients during Chemotherapy Using Ecological Momentary Assessment.

PURPOSE: To examine the relationship between daily fluctuations in symptoms and sedentary behavior (SB) during chemotherapy (CT) for breast cancer. METHODS: Breast cancer patients ( N = 68, M age = 48.5 ± 10.4 yr) undergoing CT wore an activity monitor on their hip to assess daily SB and completed prompts assessing symptoms (affect, anxiety, depression, fatigue, pain, and physical and cognitive functioning) for 10 consecutive days (3 d pre-CT, day of, and 6 d post-CT) at the beginning, middle and end cycles of CT. Mixed models assessed the bidirectional between-person (BP) and within-person (WP) associations of current day symptoms with minutes of SB measured on 1) the same day and 2) the next day, controlling for relevant covariates. RESULTS: Within person same-day results revealed a significant association between affect, anxiety, fatigue, physical functioning, pain, and cognitive functioning and same-day SB. Worse than average symptom ratings on a given day were associated with more SB that day. There was a significant WP relationship between previous-day anxiety, depression, and physical function and next-day SB (i.e., worse than average symptom ratings the previous day were associated with more SB the next day). Within person same-day results revealed a significant association between same-day SB and affect, anxiety, fatigue, pain, physical functioning, and cognitive functioning. The WP relationships were significant for previous-day SB and next-day affect and pain (i.e., higher than average SB associated with lower ratings). Relationships persisted when controlling for moderate-to-vigorous physical activity. There were no significant BP results. CONCLUSIONS: Higher symptom ratings were associated with increased SB and higher SB was associated with worse symptoms. Future work should identify SB reduction intervention approaches tailoring to daily symptom burden during CT for breast cancer.

Using ecological momentary assessment to understand associations between daily physical activity and symptoms in breast cancer patients undergoing chemotherapy.

PURPOSE: Understanding real-time relationships between physical activity (PA) and symptoms during chemotherapy (CT) could have important implications for intervention. This study used ecological momentary assessment to examine the relationship between objective PA and symptoms during CT. METHODS: Breast cancers patients (n = 67; Mage = 48.6 (SD = 10.3)) participated in data collection at three time points during CT: beginning, middle, and end. At each time point, participants answered four prompts assessing symptoms and wore an accelerometer for 10 days (3 days pre-CT, day of CT, and 6 days post-CT). Multilevel linear regression models examined the between- and within-person associations between moderate to vigorous (MVPA) and light-intensity physical activity (LPA) and same and next-day symptom ratings controlling for covariates. RESULTS: On days when individuals engaged in more LPA or MVPA, separately, they reported improved affect, anxiety, fatigue, physical functioning (walking and activities of daily living), pain, and cognition that day (p < 0.001 for all). Findings were consistent for next-day symptom ratings with the exception that only previous day LPA was related to next-day fatigue and neither LPA nor MVPA were related to next-day cognition (p < 0.001 for all). No between-person effects were found. CONCLUSIONS: Within person higher than usual PA on a given day, regardless of intensity, is associated with improved symptoms ratings on the current and next day. IMPLICATIONS FOR CANCER SURVIVORS: Encouraging breast cancer patients undergoing CT to engage in daily PA could help manage CT-associated symptoms.

Social cognitive variables and physical activity during chemotherapy for breast cancer: An intensive longitudinal examination.

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.

User-centered development of a smartphone application (Fit2Thrive) to promote physical activity in breast cancer survivors.

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.

Optimization of a technology-supported physical activity promotion intervention for breast cancer survivors: Results from Fit2Thrive.

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.

A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial.

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.