Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial.

INTRODUCTION: Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response. METHODS AND ANALYSIS: The research is a randomised controlled trial among breast cancer survivors aged 18-74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale. ETHICS AND DISSEMINATION: The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04088708.

Impact of the COVID-19 Pandemic on Physical Activity among Mostly Older, Overweight Black Women Living in the Rural Alabama Black Belt.

Despite well-documented global declines in physical activity (PA) during the COVID-19 pandemic, little is known regarding the specific impact among underserved, rural Alabama counties. This is concerning as this region was already disproportionately burdened by inactivity and related chronic diseases and was among the hardest hit by COVID-19. Thus, the current study examined the effect of COVID-19 on PA in four rural Alabama counties. An ancillary survey was administered between March 2020 and August 2021 to the first cohort (N = 171) of participants enrolled in a larger PA trial. Main outcomes of this survey included the perceived impact of COVID-19 on PA, leisure-time PA, and social cognitive theory (SCT) constructs at 3 months. Almost half of the participants reported being less active during the pandemic (49.7%) and endorsed that COVID-19 made PA more difficult (47.4%), citing concerns such as getting sick from exercising outside of the home (70.4%) and discomfort wearing a face mask while exercising (58%). Perceived COVID-19 impact on PA was significantly associated with education, household dependents, and gender (p's < 0.05). More women, parents, and college graduates reported that the COVID-19 pandemic made PA more difficult. Overall, there were no significant associations between PA, SCT constructs, or perceived COVID-19 impact on PA scores at 3 months. While the pandemic made PA difficult for many participants, these barriers were not associated with leisure-time PA levels or related theoretical mechanisms of action, which bodes well for the success of our ongoing intervention efforts and the resiliency of these communities.

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.

Exercise during chemotherapy: Friend or foe?

BACKGROUND: A higher chemotherapy completion rate is associated with better outcomes including treatment efficacy and overall survival. Exercise may have the potential to improve relative dose intensity (RDI) by reducing the frequency and severity of chemotherapy-related toxicities. We examined the association between exercise adherence and RDI and possible clinical- and health-related fitness predictors of RDI. METHODS: Chemotherapy records were extracted from the electronic medical record for patients enrolled in the ENACT trial (n = 105). Chemotherapy completion was assessed using average RDI. A threshold of 85% was established for "high" versus "low" RDI. Logistic regression analyses were used to estimate the associations between the clinical- and health-related fitness predictors of RDI. RESULTS: Patients with breast cancer (BC) had a significantly higher average RDI (89.8% ± 17.6%) compared with gastrointestinal cancer (GI) (76.8% ± 20.9%, p = 0.004) and pancreatic cancer (PC) (65.2% ± 20.1%, p < 0.001). Only 25% of BC patents required a dose reduction compared to 56.3% of GI and 86.4% of PC patients. Cancer site was significantly associated with RDI. Compared with BC, patients with GI (ß = -0.12, p = 0.03) and PC (ß = -0.22, p = 0.006) achieved significantly lower RDI. Every 2.72 unit increase in overall exercise adherence led to a significant 7% decrease in RDI (p = 0.001) in GI patients. Metastatic GI patients had a 15% RDI increase for every 2.72 unit increase in exercise adherence (p = 0.04). CONCLUSION: Exercise is a supportive therapy that has potential to enhance chemotherapy tolerance and completion. The relationship between exercise adherence and RDI is influenced by factor such as cancer site and treatment type. Special attention must be paid to how exercise is prescribed to ensure that exercise adherence does not negatively affect RDI. Cancer site, exercise dosage, and multimodal interventions to address toxicities are key areas identified for future research.

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.

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.

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.

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study.

BACKGROUND: Internet-based lifestyle programs are increasingly being used to deliver health behavior change interventions to survivors of cancer. However, little is known about website use in this population or its association with healthy lifestyle changes. OBJECTIVE: The aim of this study is to describe lifestyle intervention website use (log-ins, time on website, and page views) among survivors of cancer and patterns of use by participant characteristics. In addition, associations were explored between website use and changes in healthy lifestyle knowledge and practice. METHODS: A total of 35 survivors of cancer were recruited between August 2017 and 2018 to participate in a 2-week, single-arm pilot test of the SurvivorSHINE lifestyle intervention website. Knowledge and practices related to healthy diet and physical activity behaviors were measured at baseline and follow-up. Website use (eg, time spent on the website, frequency of log-ins, and page views) were collected from the SurvivorSHINE administrative site during the intervention period. Patterns of use were examined by participants' gender and race. Correlations between website use and changes in healthy lifestyle knowledge, physical activity, diet, and weight were explored. Mann-Whitney U tests were used to compare demographic factors on website use. RESULTS: Participants logged into the SurvivorSHINE intervention website an average of 3.2 (SD 2) times over the 2-week period and spent a total average of 94 (SD 56) minutes viewing the website during the intervention. Examining website activity, 1905 page views were logged. The User Profile (344 page views) and Home sections (301 page views) were the most frequently visited components. No associations were observed between the frequency of log-ins or the total time on the website, improvements in knowledge related to healthy lifestyles, or changes in body weight or dietary intake. However, the total time on the website was positively correlated with improvements in accelerometer-measured physical activity (r=0.74; P=.02) and self-reported physical activity (r=0.35; P=.04). CONCLUSIONS: Survivors of cancer demonstrated clear interest in a diet and exercise intervention website, as evidenced by their frequency of log-ins, page views on numerous features, and total viewing time. Moreover, increased website use was correlated with improvements in physical activity.

An Interactive Voice Response System to Increase Physical Activity and Prevent Cancer in the Rural Alabama Black Belt: Design and Usability Study.

BACKGROUND: Increased physical activity (PA) levels are associated with reduced risk and improved survival for several cancers; however, most Americans engage in less than the recommended levels of PA. Using interactive voice response (IVR) systems to provide personalized health education and counseling may represent a high-reach, low-cost strategy for addressing physical inactivity and cancer disparities in disproportionately burdened rural regions. However, there has been a paucity of research conducted in this area to date. OBJECTIVE: The aim of this study is to design, develop, and test the usability of an IVR system aimed at increasing PA levels in the rural Alabama Black Belt. METHODS: A pilot version of the IVR system was used to assess initial feasibility and acceptability. Detailed exit interviews were conducted to elicit participant feedback, which helped inform the development of a substantially upgraded in-house IVR system. This refined IVR system was then subjected to a sequential explanatory mixed methods evaluation. Participating rural county coordinators and research staff (N=10) tested the usability of the IVR system features for 2 weeks and then completed the System Usability Scale and qualitative semistructured interviews. RESULTS: The study sample comprised mostly African American people, women, rural county coordinators, and research staff (N=10). Participants rated the IVR system with a mean score of 81 (SD 5) on the System Usability Scale, implying excellent usability. In total, 5 overarching themes emerged from the qualitative interviews: likes or dislikes of the intervention, barriers to or facilitators of PA, technical difficulties, quality of calls, and suggestions for intervention improvement. Message framing on step feedback, call completion incentives, and incremental goal-setting challenges were areas identified for improvement. The positive areas highlighted in the interviews included the personalized call schedules, flexibility to call in or receive a call, ability to make up for missed calls, narration, and PA tips. CONCLUSIONS: The usability testing and feedback received from the rural county coordinators and research staff helped inform a final round of refinement to the IVR system before use in a large randomized controlled trial. This study stresses the importance of usability testing of all digital health interventions and the benefits it can offer to the intervention.

Testing the acceptability and feasibility of a tablet-based supportive cancer platform for patients with metastatic breast cancer.

BACKGROUND: Although metastatic breast cancer (MBC) survival is improving, symptoms remain a significant burden. Returning to a cancer center for symptom management can be challenging. Technology-enabled supportive care platforms are worth exploration. METHODS: Seventeen patients with MBC were randomized to immediate or delayed start for a 3-month intervention that included daily tablet-based guideline-concordant self-care for pain, distress, fatigue, and sleep disturbance, as well as weekly calls with a patient navigator. The primary outcome was patient acceptability. We also assessed feasibility, patient satisfaction, and cost and compared between group differences for symptoms. RM-ANOVA examined between group differences over time. Hedges' d effect sizes quantified magnitude of differences in change between immediate and delayed start. RESULTS: Sixty-eight percent of patients approached accepted the tablet-based intervention. Patients interacted with the tablet 48% of possible days. Patient satisfaction ranged from 83 for walking to 49% for the psychological interventions. The cost of delivering Nurse AMIE for 3 months was $570.23. Small nonsignificant improvements were found for fatigue (d=0.24). Nonsignificant, but potentially clinically meaningful, moderate reductions were found for sleep (d=0.65) and distress (d=0.74). DISCUSSION: A tablet-based supportive care platform that offers guideline-concordant self-care for pain, fatigue, sleep, and distress was observed to be highly acceptable and feasible for patients with metastatic breast cancer. Patient satisfaction scores and initial evaluation of efficacy are promising, and the platform warrants further investigation. IMPLICATIONS FOR CANCER SURVIVORS: Technology-based self-care is a promising option to address symptoms in patients with metastatic breast cancer.

The exercise in all chemotherapy trial.

BACKGROUND: Multiple international organizations have called for exercise to become standard practice in the setting of oncology care. The feasibility of integrating exercise within systemic chemotherapy has not been investigated. METHODS: Patients slated to receive infusion therapy between April 2017 and October 2018 were screened for possible inclusion. The study goal was to establish the acceptability and feasibility of embedding an exercise professional into the chemotherapy infusion suite as a method of making exercise a standard part of cancer care. The exercise prescriptions provided to patients were individualized according to results of brief baseline functional testing. RESULTS: In all, 544 patients were screened, and their respective treating oncologists deemed 83% of them to be medically eligible to participate. After further eligibility screening, 226 patients were approached. Nearly 71% of these patients (n = 160) accepted the invitation to participate in the Exercise in All Chemotherapy trial. Feasibility was established because 71%, 55%, 69%, and 63% of the aerobic, resistance, balance, and flexibility exercises prescribed to patients were completed. Qualitative data also supported the acceptability and feasibility of the intervention from the perspective of patients and clinicians. The per-patient cost of the intervention was $190.68 to $382.40. CONCLUSIONS: Embedding an exercise professional into the chemotherapy infusion suite is an acceptable and feasible approach to making exercise standard practice. Moreover, the cost of the intervention is lower than the cost of other common community programs. Future studies should test whether colocating an exercise professional with infusion therapy could reach more patients in comparison with not colocating. LAY SUMMARY: Few studies have tested the implementation of exercise for patients with cancer by embedding an exercise professional directly into the chemotherapy infusion suite. The Exercise in All Chemotherapy trial shows that this approach is both acceptable and feasible from the perspective of clinicians and patients.

Understanding Nutritional Problems of Metastatic Breast Cancer Patients: Opportunities for Supportive Care Through eHealth.

BACKGROUND: Metastatic breast cancer patients are now living longer but cope with potential symptoms of metastatic disease and prolonged cancer treatment. Nutrition can play a vital role in managing these sequelae, and eHealth tools are emerging as promising delivery options for nutrition interventions. OBJECTIVE: To qualitatively assess nutritional problems and concerns of women with metastatic breast cancer and to explore how to address these problems within an existing eHealth platform. METHODS: Semistructured interviews were conducted with 21 women with metastatic breast cancer participating in an ongoing eHealth study. Interviews were audiotaped, transcribed verbatim, and analyzed using a team-based content analysis approach. RESULTS: Most respondents reported currently or previously experiencing nutritional problems due to adverse effects of cancer treatment or the disease itself; these were rarely addressed during routine clinical care. Five major themes emerged: (1) knowledge about nutrition, (2) nutrition information-seeking, (3) social aspects of nutrition, (4) nutrition interest, and (5) how to address nutrition with an eHealth platform. The respondents reported diverse experiences and perspectives regarding nutrition and diet in the context of metastatic breast cancer within each theme. CONCLUSION: Findings indicate the importance of providing women with metastatic breast cancer with information about nutrition that is tailored to their specific disease, as these patients report both nutritional problems and uncertainty regarding nutritional strategies. IMPLICATIONS FOR PRACTICE: These findings are a first step toward designing supportive care interventions that could fill the gap related to nutritional concerns not addressed during routine clinical care.

Effects of Resistance Training and Protein Supplementation in Breast Cancer Survivors.

PURPOSE: This study aimed to evaluate 12 wk of resistance training (RT; n = 16) and protein supplementation (RT + protein; n = 17) on muscular strength, body composition, and blood biomarkers of muscle (insulin-like growth factor 1 [IGF-1]), fat (adiponectin), and inflammation (human C-reactive protein [CRP]) in breast cancer survivors (BCS). METHODS: Thirty-three BCS (59 ± 8 yr) were measured pre- and posttraining for one-repetition maximum (1-RM) muscular strength (chest press and leg extension), body composition (lean mass [LM] and fat mass [FM]) via dual-energy x-ray absorptiometry, and serum concentrations of IGF-1, adiponectin, and CRP. RT consisted of 2 d·wk using 10 exercises for two sets of 10-12 repetitions and a third set to failure at ~65%-85% of 1-RM. RT + protein consumed 20 g of protein twice a day. ANOVA was used for analyses. Significance was set at P ≤ 0.05. RESULTS: Average RT intensity was 65%-81% of 1-RM and was not different between RT and RT + protein. There were no group-time interactions for strength, LM, FM, and biomarkers. Both groups significantly increased upper (+31 ± 18 kg) and lower (+19 ± 12 kg) body strength, LM (+0.9 ± 1.0 kg) and decreased FM (-0.5 ± 1.2 kg), and percent body fat (-1.0% ± 1.2%). Serum levels of IGF-1 significantly increased from baseline to 12 wk in both RT (102 ± 34 to 115 ± 33 ng·mL) and RT + protein (110 ± 40 to 119 ± 37 ng·mL); adiponectin and CRP did not change. CONCLUSIONS: Twelve weeks of RT at 65%-81% of 1-RM, 2 d·wk in BCS, was well tolerated and significantly improved strength, body composition, and IGF-1. Supplemental protein (40 g·d) did not induce a change in any variable. However, on the basis of food logs, reductions in total calories and dietary protein intake from whole foods resulted in only a net protein increase of 17 g·d for RT + protein, which may have influenced the results.