Feasibility and preliminary effects of the Fit2ThriveMB pilot physical activity promotion intervention on physical activity and patient reported outcomes in individuals with metastatic breast cancer.

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.

A Framework for Integrating Telehealth Equitably across the cancer care continuum.

The COVID-19 pandemic placed a spotlight on the potential to dramatically increase the use of telehealth across the cancer care continuum, but whether and how telehealth can be implemented in practice in ways that reduce, rather than exacerbate, inequities are largely unknown. To help fill this critical gap in research and practice, we developed the Framework for Integrating Telehealth Equitably (FITE), a process and evaluation model designed to help guide equitable integration of telehealth into practice. In this manuscript, we present FITE and showcase how investigators across the National Cancer Institute's Telehealth Research Centers of Excellence are applying the framework in different ways to advance digital and health equity. By highlighting multilevel determinants of digital equity that span further than access alone, FITE highlights the complex and differential ways structural determinants restrict or enable digital equity at the individual and community level. As such, achieving digital equity will require strategies designed to not only support individual behavior but also change the broader context to ensure all patients and communities have the choice, opportunity, and resources to use telehealth across the cancer care continuum.

Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment.

Northwestern University's Center for Scalable Telehealth Cancer Care (STELLAR) is 1 of 4 Cancer Moonshot Telehealth Research Centers of Excellence programs funded by the National Cancer Institute to establish an evidence base for telehealth in cancer care. STELLAR is grounded in the Institute of Medicine's vision that quality cancer care includes not only disease treatment but also promotion of long-term health and quality of life (QOL). Cigarette smoking, insufficient physical activity, and overweight and obesity often co-occur and are associated with poorer treatment response, heightened recurrence risk, decreased longevity, diminished QOL, and increased treatment cost for many cancers. These risk behaviors are prevalent in cancer survivors, but their treatment is not routinely integrated into oncology care. STELLAR aims to foster patients' long-term health and QOL by designing, implementing, and sustaining a novel telehealth treatment program for multiple risk behaviors to be integrated into standard cancer care. Telehealth delivery is evidence-based for health behavior change treatment and is well suited to overcome access and workflow barriers that can otherwise impede treatment receipt. This paper describes STELLAR's 2-arm randomized parallel group pragmatic clinical trial comparing telehealth-delivered, coach-facilitated multiple risk behavior treatment vs self-guided usual care for the outcomes of reach, effectiveness, and cost among 3000 cancer survivors who have completed curative intent treatment. This paper also discusses several challenges encountered by the STELLAR investigative team and the adaptations developed to move the research forward.

Increasing physical activity among older adults with gynecologic cancers: a qualitative study.

PURPOSE: The purpose of this study was to gain an understanding of older gynecologic cancer patients' preferences and opinions related to physical activity during chemotherapy, including interventions to promote physical activity. METHODS: Gynecologic cancer patients 60 years or older receiving chemotherapy at a single institution within the last 12 months completed questionnaires and a semi-structured interview asking about their preferences for physical activity interventions aimed at promoting physical activity while receiving treatment. RESULTS: Among the 30 gynecologic cancer patients surveyed and interviewed, a majority agreed with the potential usefulness of a physical activity intervention during chemotherapy (67%) and most reported they would be willing to use an activity tracker during chemotherapy (73%). They expressed a preference for an aerobic activity intervention such as walking, indicated a desire for education from their clinical team on the effects physical activity can have on treatment symptoms, and stated a need for an intervention that could be accessed from anywhere and anytime. Additionally, they emphasized a need for an intervention that considered their treatment symptoms as these were a significant barrier to physical activity while on chemotherapy. CONCLUSION: In this study of older gynecologic cancer patients receiving chemotherapy, most were open to participating in a virtually accessible and symptom-tailored physical activity intervention to promote physical activity during chemotherapy.

StandUPTV: Preparation and optimization phases of a mHealth intervention to reduce sedentary screen time in adults.

Recreational sedentary screen time (rSST) is the most prevalent sedentary behavior for adults outside of work, school, and sleep, and is strongly linked to poor health. StandUPTV is a mHealth trial that uses the Multiphase Optimization Strategy (MOST) framework to develop and evaluate the efficacy of three theory-based strategies for reducing rSST among adults. This paper describes the preparation and optimization phases of StandUPTV within the MOST framework. We identified three candidate components based on previous literature: (a) rSST electronic lockout (LOCKOUT), which restricts rSST through electronic means; (b) adaptive prompts (TEXT), which provides adaptive prompts based on rSST behaviors; and (c) earning rSST through increased moderate-vigorous physical activity (MVPA) participation (EARN). We also describe the mHealth iterative design process and the selection of an optimization objective. Finally, we describe the protocol of the optimization randomized controlled trial using a 23 factorial experimental design. We will enroll 240 individuals aged 23-64 y who engage in >3 h/day of rSST. All participants will receive a target to reduce rSST by 50% and be randomized to one of 8 combinations representing all components and component levels: LOCKOUT (yes vs. no), TEXT (yes vs. no), and EARN (yes vs. no). Results will support the selection of the components for the intervention package that meet the optimization objective and are acceptable to participants. The optimized intervention will be tested in a future evaluation randomized trial to examine reductions in rSST on health outcomes among adults.

Effects of mindful physical activity on perceived exercise exertion and other physiological and psychological responses: results from a within-subjects, counter-balanced study.

Background: Most adults are insufficiently active. Mindfulness training may increase moderate to vigorous physical activity (MVPA) adoption and adherence. However, physiological and psychological factors underlying these effects are not well understood. This study examined the effects of an acute bout of MVPA, mindfulness training, and combined MVPA and mindfulness training on physiological and psychological outcomes. Methods: Healthy adults (N = 29, Mage = 28.6) completed 20-min counterbalanced conditions: (a) mindfulness training (MIND); (b) moderate intensity walking (PA), and (c) moderate intensity walking while listening to MVPA-specific guided mindfulness training (PAMIND). Heart rate (HR), Rating of Perceived Exertion (RPE), Feeling Scale (FS) and Blood Pressure (BP) were measured at rest, at regular intervals during each condition, and post-condition. Mindfulness, state anxiety, and self-efficacy were assessed pre- and post-condition. Results: Average and peak HR, systolic BP (SBP), and RPE were significantly higher, and average and peak FS were significantly lower during the PA and PAMIND conditions compared to MIND (p < 0.001). Average RPE was significantly higher for PA compared to PAMIND (p < 0.001). Heart rate, feeling scale, body and mental events mindfulness, and self-efficacy for walking increased from pre to post (all p's < 0.001) for all conditions. Time by condition interactions were significant for change in heart rate, mental events mindfulness, and state anxiety from pre- to post-condition. Conclusion: The physiological response to MVPA and PAMIND were similar. However, RPE was rated lower in the PAMIND condition, which could have implications for MVPA adoption and maintenance. Future work should further explore RPE combining MVPA and mindfulness training.

Associations between Symptoms and Exercise Barriers in Breast Cancer Survivors.

Despite exercise benefits for cancer survivor health, most breast cancer survivors do not meet exercise recommendations. Few studies have examined associations between psychosocial symptoms and exercise barriers in this population. To improve physician exercise counseling by identifying survivors with high barriers in a clinical setting, associations between breast cancer symptoms (fatigue, mood, sleep quality) and exercise barriers were investigated. Physically inactive survivors (N = 320; average age 55 ± 8 years, 81% White, 77% cancer stage I or II) completed a baseline survey for a randomized physical activity trial and secondary analyses were performed. Potential covariates, exercise barriers interference score, Fatigue Symptom Inventory, Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index were assessed. Based on multiple linear regression analyses, only HADS Global (B = 0.463, p < 0.001) and number of comorbidities (B = 0.992, p = 0.01) were independently associated with total exercise barriers interference score, explaining 8.8% of the variance (R2 = 0.088, F(2,317) = 15.286, p < 0.001). The most frequent barriers to exercise for survivors above the HADS clinically important cut point included procrastination, routine, and self-discipline. These results indicate greater anxiety levels, depression levels, and comorbidities may be independently associated with specific exercise barriers. Health professionals should consider mood and comorbidities when evaluating survivors for exercise barriers, and tailoring exercise counseling.

Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial.

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.

A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol.

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.

Breast cancer survivors' exercise preferences change during an exercise intervention are associated with post-intervention physical activity.

PURPOSE: Exercise program preferences are important for designing physical activity (PA) interventions; yet may change following an intervention. Further, the relationship between preferences and PA behavior change is unclear. This study evaluated exercise program preferences among breast cancer survivors (BCS) before and after a behavioral intervention and associations between program preferences and PA change. METHODS: BCS were randomized to the BEAT Cancer intervention (n = 110) or written materials (n = 112). Questionnaires assessed exercise program preferences. Minutes per week of moderate-to-vigorous PA (MVPA) were accelerometer-measured and self-reported at baseline (M0), post-intervention (M3), and 3-month follow-up (M6). RESULTS: At M0, the majority of intervention group participants preferred exercising with others (62%) yet shifted to preferring exercising alone (59%) at M3 (p < 0.001). Furthermore, preferring exercising with others at M0 was associated with greater increases in self-reported MVPA between M0 and M6 (124.2 ± 152 vs. 53.1 ± 113.8, p = 0.014). BCS preferring facility-based exercise decreased after the BEAT Cancer intervention (14% vs. 7%, p = 0.039) and preferring exercising at home/had no preference at M0 had greater improvements in accelerometer-measured MVPA from M0 to M3 (74.3 ± 118.8 vs. -2.3 ± 78.4, p = 0.033) and M0 to M6 (44.9 ± 112.8 vs. 9.3 ± 30.4, p = 0.021). Exercise program preferences regarding mode of counseling, training supervision, and type of exercise changed from M0 to M3 but were not associated with changes in MVPA. CONCLUSION: Findings suggest BCS exercise program preferences may change after an intervention and be associated with changes in MVPA. Understanding the role of PA preferences will better inform the design and success of PA behavior change interventions. ClinicTrials.gov, ClinicalTrials.gov number: NCT00929617.

Relationships between Obesity, Exercise Preferences, and Related Social Cognitive Theory Variables among Breast Cancer Survivors.

Breast cancer survivors with obesity have an increased risk of cancer recurrence, second malignancy, and comorbidities. Though physical activity (PA) interventions are needed, investigation of the relationships between obesity and factors influencing PA program aspects among cancer survivors remain understudied. Thus, we conducted a cross-sectional study examining associations amongst baseline body mass index (BMI), PA program preferences, PA, cardiorespiratory fitness, and related social cognitive theory variables (self-efficacy, exercise barriers interference, social support, positive and negative outcome expectations) from a randomized controlled PA trial with 320 post-treatment breast cancer survivors. BMI was significantly correlated with exercise barriers interference (r = 0.131, p = 0.019). Higher BMI was significantly associated with preference to exercise at a facility (p = 0.038), lower cardiorespiratory fitness (p < 0.001), lower walking self-efficacy (p < 0.001), and higher negative outcome expectations (p = 0.024), independent of covariates (comorbidity score, Western Ontario and McMaster Universities osteoarthritis index score, income, race, education). Those with class I/II obesity reported a higher negative outcome expectations score compared with class III. Location, walking self-efficacy, barriers, negative outcome expectations, and fitness should be considered when designing future PA programs among breast cancer survivors with obesity.

Physical activity intervention benefits persist months post-intervention: randomized trial in breast cancer survivors.

PURPOSE: Determine durable effects of the 3-month Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) physical activity (PA) behavior change intervention 12 months post-baseline (i.e., 9 months after intervention completion). METHODS: This 2-arm multicenter trial randomized 222 post-primary treatment breast cancer survivors to BEAT Cancer (individualized exercise and group education) vs. usual care (written materials). Assessments occurred at baseline, 3, 6, and 12 months, with the 12 months assessment reported here. Measures included PA (accelerometer, self-report), cardiorespiratory fitness, muscle strength, body mass index, Functional Assessment of Cancer Therapy (FACT), SF-36, fatigue, depression, anxiety, satisfaction with life, Pittsburgh Sleep Quality Index (PSQI), lower extremity joint dysfunction, and perceived memory. RESULTS: Adjusted linear mixed-model analyses demonstrated statistically significant month 12 between-group differences favoring BEAT Cancer for weekly minutes of moderate-to-vigorous self-report PA (mean between-group difference (M) = 44; 95% confidence interval (CI) = 12 to 76; p = .001), fitness (M = 1.5 ml/kg/min; CI = 0.4 to 2.6; p = .01), FACT-General (M = 3.5; CI = 0.7 to 6.3; p = .014), FACT-Breast (M = 3.6; CI = 0.1 to 7.1; p = .044), social well-being (M = 1.3; CI = 0.1 to 2.5; p = .037), functional well-being (M = 1.2; CI = 0.2 to 2.3; p = .023), SF-36 vitality (M = 6.1; CI = 1.4 to 10.8; p = .011), fatigue (M = - 0.7; CI = - 1.1 to - 0.2; p = .004), satisfaction with life (M = 1.9; CI = 0.3 to 3.5; p = .019), sleep duration (M = - 0.2; CI = - 0.4 to - 0.03, p = .028), and memory (M = 1.1; CI = 0.2 to 2.1; p = .024). CONCLUSIONS: A 3-month PA intervention resulted in statistically significant and clinically important benefits compared to usual care at 12 months. IMPLICATIONS FOR CANCER SURVIVORS: Three months of individualized and group PA counseling causes benefits detectable 9 months later. TRIAL REGISTRATION: ClinicalTrials.gov NCT00929617 ( https://clinicaltrials.gov/ct2/show/NCT00929617 ; registered June 29, 2009).

Breast Cancer Survivors' Exercise Preferences Change During an Exercise Intervention and are associated with Post-Intervention Physical Activity.

Purpose Exercise program preferences are important for designing physical activity (PA) interventions; yet may change following an intervention. Further, the relationship between preferences and PA behavior change is unclear. This study evaluated exercise program preferences among breast cancer survivors (BCS) before and after a behavioral intervention and associations between program preferences and PA change. Methods BCS were randomized to the BEAT Cancer intervention (n = 110) or written materials (n = 112). Questionnaires assessed exercise program preferences. Minutes per week of moderate-to-vigorous PA (MVPA) were accelerometer-measured and self-reported at baseline (M0), post-intervention (M3), and 3-month follow-up (M6). Results At M0, the majority of intervention group participants preferred exercising with others (62%) yet shifted to preferring exercising alone (59%) at M3 ( p < 0.001). Furthermore, preferring exercising with others at M0 was associated with greater increases in self-reported MVPA between M0 and M6 (124.2 ± 152 vs. 53.1 ± 113.8, p = 0.014). BCS preferring facility-based exercise decreased after the BEAT Cancer intervention (14% vs. 7%, p = 0.039) and preferring exercising at home/had no preference at M0 had greater improvements in accelerometer-measured MVPA from M0 to M3 (74.3 ± 118.8 vs. -2.3 ± 78.4, p = 0.033) and M0 to M6 (44.9 ± 112.8 vs. 9.3 ± 30.4, p = 0.021). Exercise program preferences regarding mode of counseling, training supervision, and type of exercise changed from M0 to M3 but were not associated with changes in MVPA. Conclusion Findings suggest BCS exercise program preferences may change after an intervention and be associated with changes in MVPA. Understanding the role of PA preferences will better inform the design and success of PA behavior change interventions. ClinicTrials.gov, ClinicalTrials.gov number: NCT00929617.

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.

Moderators of physical activity and quality of life response to a physical activity intervention for breast cancer survivors.

PURPOSE: Moderate-to-vigorous physical activity (MVPA) can improve the quality of life (QoL) for breast cancer survivors (BCS), yet, most do not achieve 150 + weekly minutes of MVPA. This study investigated moderators of response to a physical activity (PA) behavior change intervention for BCS. METHODS: BCS (N = 222) were randomized to the 3-month intervention (BEAT Cancer) or usual care. Measurements occurred at baseline, post-intervention, and 3 months post-intervention. Measures included accelerometry, self-reported MVPA, and Functional Assessment of Cancer Therapy (FACT-General, FACT-Breast, physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), additional concerns (AC), and Trial Outcome Index (TOI)). RESULTS: Adjusted linear mixed-model analyses indicated individuals ≤ 24 months post-diagnosis and who were single reported smaller increases in weekly self-reported MVPA than those > 24 months (44.07 vs 111.93) and partnered (- 16.24 vs. 49.16 min), all p < 0.05. As for QoL, participants < 12 months post-diagnosis who received chemotherapy experienced smaller improvements than those ≥ 12 months in FACT-General, FACT-Breast, PWB, and SWB scores. Survivors with a history of chemotherapy had smaller improvements in FACT-General, FACT-Breast, PWB, SWB, TOI, and AC scores, all p < 0.05. CONCLUSION: These findings indicate that being < 2 years post-diagnosis, single, and prior chemotherapy may limit MVPA and QOL responses to a PA intervention. Further studies are needed to determine if and/or what additional PA supports and resources these subgroups of BCS might find beneficial and effective. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT00929617.

Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment.

BACKGROUND: Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States. The American Cancer Society (ACS) Nutrition and Physical Activity Guidelines are associated with longer survival among CRC survivors, but few report behaviors consistent with the guidelines. METHODS: The Tools To Be Fit study, based on the Multiphase Optimization Strategy (MOST) framework, is a full factorial experimental to optimize a remotely delivered 48-week diet and physical activity intervention for non-metastatic CRC survivors. The intervention includes a core component (booklet and personal report). CRC survivors (N = 400) are additionally randomly assigned to one of 16 combinations of four candidate components, each with 2 options: 1) text messaging (on/off); 2) self-monitoring modality (digital/paper); 3) health coaching (on/off); and 4) support person coaching (on/off). OUTCOMES: Our primary outcome is adherence to the ACS guidelines after 48 weeks using a score that includes physical activity from accelerometers, dietary intake from a food frequency questionnaire, and body mass index (BMI) measured by a technician. Secondary outcomes include the ACS score after 24 weeks and score components at 24 and 48 weeks. Exploratory outcomes include adherence and change in Social Cognitive Theory constructs. We will explore moderation by sociodemographic, clinical, and psychological/behavioral factors; and change in the ACS score in relation to change in levels of insulin, insulin sensitivity, inflammation, gut microbiome structure, fatigue, depression, and sleep disturbance. DISCUSSION: The proposed study aims to inform a randomized controlled trial to determine whether an optimized intervention reduces risk of recurrence among CRC survivors.

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.