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.

Dietary Barriers Appear to Influence the Effects of a Dyadic Web-Based Lifestyle Intervention on Caloric Intake and Adiposity: A Mediation Analysis of the DUET Trial.

Mechanisms that explain behavior change within web-based lifestyle interventions are not well-studied. This secondary analysis explores whether the effects of the DUET web-based lifestyle intervention on diet, physical activity, and/or adiposity are mediated through changes in self-efficacy, social support, and perceived barriers (key constructs of social cognitive theory). Data on mediators, diet quality, caloric intake, moderate-to-vigorous physical activity (MVPA), weight, and waist circumference (WC) were analyzed from 112 cancer survivors and their partners enrolled in the DUET intervention. Mediation analyses were performed using Mplus to execute regression analyses and determine associations. Mediation analyses supported an effect of the intervention on caloric intake (-3.52, 95% CI [-8.08 to -0.84]), weight (-1.60, CI [-3.84 to -0.47]), and WC (-0.83, CI [-1.77 to -0.18]), interpreting these negative associations as intervention induced reductions in dietary barriers. Higher social support was significantly and positively associated with, but not a mediator for, improvements in self-reported and accelerometry-measured MVPA (b = 0.69, CI [0.19, 1.24]) and (b = 0.55, CI [0.15, 1.00]), respectively. Self-efficacy did not appear to mediate the intervention's effects. Findings suggest that the effects of the DUET intervention on diet and adiposity stem from reducing perceived barriers to a healthful, low-calorie diet.

Implementation of the Web-Enabled Cancer & Aging Resilience Evaluation (WeCARE) in an outpatient oncology setting.

INTRODUCTION: Although geriatric assessments (GAs) are recommended for use in older adults with cancer, their integration into oncology practice remain suboptimal. Here, we report our experience integrating web-enabled GA (WeCARE) into oncology practice as an augmented delivery method and provider interface format to overcome implementation barriers. MATERIALS AND METHODS: Older patients (≥60 years) with a gastro-intestinal (GI) malignancy presenting for an initial visit to medical oncology clinic at a single institution between December 7, 2021 and October 10, 2022 were contacted by staff two days in advance of their visits and sent a link to the WeCARE GA, rather than the paper version used previously. Results were directly embedded into the medical record. We describe our initial implementation outcomes and the results of a provider usability survey. RESULTS: Of 266 eligible patients, 221 (83.1%) were successfully contacted by telephone and 200 (75.2%) completed the WeCARE prior to their appointment. More than one phone call was required to make contact for 35.7% of patients, with a mean duration of phone conversation of 2.8 min. Most patients preferred email delivery to text (63% vs 31%); 4.5% were unable to access surveys due to inadequate technology, and 25.7% brought up additional logistical concerns. Among GI oncology providers surveyed, all six found the WeCARE tool and dashboard acceptable, appropriate, and feasible. However, only a third of providers often or always used the dashboard to inform treatment decisions and guide interventions. DISCUSSION: With nearly three-quarters of patients completing the WeCARE prior to their visits with minimal staff support and time required, this method of administration may be a viable format to overcome barriers to GA implementation. Additional work is needed to integrate the results meaningfully into clinical practice.

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.

Physical Activity among Colorectal Cancer Patients and Survivors in Egypt.

INTRODUCTION: Understanding physical activity (PA) levels is important when developing tertiary cancer prevention interventions, especially in Egypt where colorectal cancer (CRC) is more often diagnosed at later stages and at a younger age of onset (≤40 years). METHODS: We assessed PA levels among CRC patients and survivors in Alexandria, Egypt. All participants completed two self-reported PA assessments: Global Physical Activity Questionnaire (GPAQ) and Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants could opt to wear an accelerometer for seven days. Results were compared against WHO recommendations of ≥150 minutes or ≥600 metabolic equivalents of tasks (METs) of moderate-to-vigorous PA weekly. RESULTS: Of 86 participants enrolled, all completed the surveys and 29 agreed to accelerometer use. Prevalence of meeting PA recommendations was 62.8% based on the GPAQ, 14.0% based on GLTEQ, and 41% based on accelerometer. Based on the GPAQ, very few respondents reported vigorous occupational, vigorous recreational, or moderate recreational activity (median = 0 with interquartile range [IQR] of 0 - 0 weekly minutes for all three) while most activity resulted from moderate occupational and transportation (median [IQR] of 60 [0-840] and 60 [0-187.5] weekly minutes, respectively). Participants meeting PA recommendations were less likely to be married (p = 0.043) according to GPAQ and more likely to be female (p=0.047) and early cancer stage (p=0.007) by GLTEQ. CONCLUSION: Non-leisure free-living PA is a major contributor to meeting PA recommendations while leisure-time PA is a potential target for future interventions that increase PA in this population.

Microbiome diversity in African American, European American, and Egyptian colorectal cancer patients.

Purpose: Although there is an established role for microbiome dysbiosis in the pathobiology of colorectal cancer (CRC), CRC patients of various race/ethnicities demonstrate distinct clinical behaviors. Thus, we investigated microbiome dysbiosis in Egyptian, African American (AA), and European American (EA) CRC patients. Patients and methods: CRCs and their corresponding normal tissues from Egyptian (n = 17) patients of the Alexandria University Hospital, Egypt, and tissues from AA (n = 18) and EA (n = 19) patients at the University of Alabama at Birmingham were collected. DNA was isolated from frozen tissues, and the microbiome composition was analyzed by 16S rRNA sequencing. Differential microbial abundance, diversity, and metabolic pathways were identified using linear discriminant analysis (LDA) effect size analyses. Additionally, we compared these profiles with our previously published microbiome data derived from Kenyan CRC patients. Results: Differential microbiome analysis of CRCs across all racial/ethnic groups showed dysbiosis. There were high abundances of Herbaspirillum and Staphylococcus in CRCs of Egyptians, Leptotrichia in CRCs of AAs, Flexspiria and Streptococcus in CRCs of EAs, and Akkermansia muciniphila and Prevotella nigrescens in CRCs of Kenyans (LDA score >4, adj. p-value <0.05). Functional analyses showed distinct microbial metabolic pathways in CRCs compared to normal tissues within the racial/ethnic groups. Egyptian CRCs, compared to normal tissues, showed lower l-methionine biosynthesis and higher galactose degradation pathways. Conclusions: Our findings showed altered mucosa-associated microbiome profiles of CRCs and their metabolic pathways across racial/ethnic groups. These findings provide a basis for future studies to link racial/ethnic microbiome differences with distinct clinical behaviors in CRC.

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors.

Objective: To facilitate replication and future intervention design of web-based multibehavior lifestyle interventions, we describe the rationale, development, and content of the AiM, Plan, and act on LIFestYles (AMPLIFY) Survivor Health intervention which provides healthy eating and exercise behavior change support for older cancer survivors. The intervention promotes weight loss, improvements in diet quality, and meeting exercise recommendations. Methods: The Template for Intervention Description and Replication (TIDieR) checklist was used to provide a comprehensive description of the AMPLIFY intervention, consistent with CONSORT recommendations. Results: A social cognitive theory web-based intervention founded on the core components of efficacious print and in-person interventions was conceptualized and developed through an iterative collaboration involving cancer survivors, web design experts, and a multidisciplinary investigative team. The intervention includes the AMPLIFY website, text and/or email messaging, and a private Facebook group. The website consists of: (1) Sessions (weekly interactive e-learning tutorials); (2) My Progress (logging current behavior, receiving feedback, setting goals); (3) Tools (additional information and resources); (4) Support (social support resources, frequently asked questions); and (5) Home page. Algorithms were used to generate fresh content daily and weekly, tailor information, and personalize goal recommendations. An a priori rubric was used to facilitate intervention delivery as healthy eating only (24 weeks), exercise only (24 weeks), or both behaviors concurrently over 48 weeks. Conclusions: Our TIDieR-guided AMPLIFY description provides pragmatic information helpful for researchers designing multibehavior web-based interventions and enhances potential opportunities to improve such interventions.

Assessing the built environment, programs, and policies that support physical activity opportunities in the rural Deep South.

Disparities in physical activity (PA) exist in rural regions and prior research suggests environmental features and community resources likely contribute. It is important to identify the opportunities and barriers that influence activity to appropriately inform PA interventions in such areas. Thus, we assessed the built environment, programs and policies related to PA opportunity in six rural Alabama counties that were purposively selected to inform a PA randomized controlled trial. Assessments were conducted August 2020-May 2021 using the Rural Active Living Assessment. Town characteristics and recreational amenities were captured using the Town Wide Assessment (TWA). PA programs and policies were examined with the Program and Policy Assessment. Walkability was evaluated using the Street Segment Assessment (SSA). Using the scoring system (0-100), the overall TWA score was 49.67 (range: 22-73), indicating few schools within walking distance (≤5 miles of the town's center) and town-wide amenities (e.g., trails, water/recreational activities) for PA. The Program and Policy Assessment showed a paucity of programming and guidelines to support activity (overall average score of 24.67, [range: 22-73]). Only one county had a policy requiring walkways/bikeways in new public infrastructure projects. During assessment of 96 street segments, few pedestrian-friendly safety features [sidewalks (32%), crosswalks (19%), crossing signals (2%), and public lighting (21%)] were observed. Limited opportunities for PA (parks and playgrounds) were identified. Barriers such as few policies and safety features (crossing signals, speed bumps) were indicated as factors that should be addressed when developing PA interventions and informing future policy efforts.

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.

Results of DUET: A Web-Based Weight Loss Randomized Controlled Feasibility Trial among Cancer Survivors and Their Chosen Partners.

(1) Background: A healthful diet, regular physical activity, and weight management are cornerstones for cancer prevention and control. Yet, adherence is low in cancer survivors and others, calling for innovative solutions. Daughters, dUdes, mothers, and othErs fighting cancer Together (DUET) is a 6-month, online, diet-and-exercise, weight-loss intervention to improve health behaviors and outcomes among cancer survivor-partner dyads. (2) Methods: DUET was tested in 56 dyads (survivors of obesity-related cancers and chosen partners) (n = 112), both with overweight/obesity, sedentary behavior, and suboptimal diets. After baseline assessment, dyads were randomized to DUET intervention or waitlist control arms; data were collected at 3- and 6-months and analyzed using chi-square, t-tests, and mixed linear models (α < 0.05). (3) Results: Retention was 89% and 100% in waitlisted and intervention arms, respectively. Dyad weight loss (primary outcome) averaged -1.1 (waitlist) vs. -2.8 kg (intervention) (p = 0.044/time-by-arm interaction p = 0.033). Caloric intake decreased significantly in DUET survivors versus controls (p = 0.027). Evidence of benefit was observed for physical activity and function, blood glucose, and c-reactive protein. Dyadic terms were significant across outcomes, suggesting that the partner-based approach contributed to intervention-associated improvements. (4) Conclusions: DUET represents a pioneering effort in scalable, multi-behavior weight management interventions to promote cancer prevention and control, calling for studies that are larger in size, scope, and duration.

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.

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.

Studying the implementation of exercise oncology interventions: a path forward.

Introduction/Purpose: Extensive scientific evidence supports exercise benefits after a cancer diagnosis and the field now needs to focus on elucidating effective strategies for implementing exercise evidence-based interventions (EBIs) for cancer survivors. Methods: This paper brings together three implementation efforts to describe pragmatic observations and strategies when implementing exercise oncology EBIs in non-research settings. From these projects, we report on common implementation barriers and facilitators. We then mapped these observations and strategies on to the phases and processes described in the Exploration, Preparation, Implementation, and Sustainment (EPIS) Framework. Results: The first implementation project used key stakeholders' perspectives to develop a toolkit to implement BEAT Cancer (Better Exercise Adherence after Treatment for Cancer), a self-managed intervention led by fitness professionals. The second project adapted a physical activity behavior change intervention (Active Living after Cancer) for use in the broader community. The third project adapted an in-person exercise intervention in a community setting (Physical Activity and Lymphedema) into an out-patient rehabilitation setting, including home-based intervention elements (Strength After Breast Cancer). We retrospectively collated and operationalized the implementation strategies based on the Experts Recommending Implementation Change (ERIC) study. The most common implementation barriers were related to funding, organizational capacity and training, relationship building, patient referral, and engagement with patients. Conclusions: These implementation strategies provide initial starting points for the implementation of exercise oncology EBIs in clinical and community settings while also serving as examples for future implementation research to advance the translation of exercise oncology evidence.

Correction: Pekmezi et al. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients 2021, 13, 3472.

The authors would like to correct errors in their prior publication [...].

Comparative responsiveness and minimally important difference of Fatigue Symptom Inventory (FSI) scales and the FSI-3 in trials with cancer survivors.

BACKGROUND: Fatigue is a highly prevalent and disabling symptom in cancer survivors. Although many measures have been developed to assess survivors' fatigue, their ability to accurately capture change following intervention has rarely been assessed in post-treatment survivors. Ultra-brief fatigue measures are preferable in clinical practice but have limited evidence supporting their use with cancer survivors. We examined the psychometric properties of four Fatigue Symptom Inventory (FSI) measures, including the new FSI-3, in cancer survivors. Examined properties included responsiveness to change and minimally important differences (MIDs). METHODS: We analyzed data from three randomized controlled trials with post-treatment cancer survivors (N = 328). Responsiveness to change was evaluated by comparing standardized response means for survivors who reported their fatigue as being better, the same, or worse at 2-3 months. Responsiveness to intervention was assessed via effect sizes, and MIDs were estimated by using several methods. We also computed area under the curve (AUC) values to assess FSI measures' discriminative accuracy compared to an established cut-point. RESULTS: All FSI measures differentiated survivors who reported improvement at 2-3 months from those with stable fatigue, but did not uniformly differentiate worsening fatigue from stable fatigue. Measures showed similar levels of responsiveness to intervention, and MIDs ranged from 0.29 to 2.20 across FSI measures. AUC analyses supported the measures' ability to detect significant fatigue. CONCLUSIONS: Four FSI scales show similar responsiveness to change, and estimated MIDs can inform assessment of meaningful change in fatigue. The FSI-3 shows promise as an ultra-brief fatigue measure for survivors.

Cancer disparities in the context of rurality: risk factors and screening across various U.S. rural classification codes.

PURPOSE: Prior cancer research is limited by inconsistencies in defining rurality. The purpose of this study was to describe the prevalence of cancer risk factors and cancer screening behaviors across various county-based rural classification codes, including measures reflecting a continuum, to inform our understanding of cancer disparities according to the extent of rurality. METHODS: Using an ecological cross-sectional design, we examined differences in cancer risk factors and cancer screening behaviors from the Behavioral Risk Factor Surveillance System and National Health Interview Survey (2008-2013) across rural counties and between rural and urban counties using four rural-urban classification codes for counties and county-equivalents in 2013: U.S. Office of Management and Budget, National Center for Health Statistics, USDA Economic Research Service's rural-urban continuum codes, and Urban Influence Codes. RESULTS: Although a rural-to-urban gradient was not consistently evident across all classification codes, the prevalence of smoking, obesity, physical inactivity, and binge alcohol use increased (all ptrend < 0.03), while colorectal, cervical and breast cancer screening decreased (all ptrend < 0.001) with increasing rurality. Differences in the prevalence of risk factors and screening behaviors across rural areas were greater than differences between rural and urban counties for obesity (2.4% vs. 1.5%), physical activity (2.9% vs. 2.5%), binge alcohol use (3.4% vs. 0.4%), cervical cancer screening (6.8% vs. 4.0%), and colorectal cancer screening (4.4% vs. 3.8%). CONCLUSIONS: Rural cancer disparities persist across multiple rural-urban classification codes, with marked variation in cancer risk factors and screening evident within rural regions. Focusing only on a rural-urban dichotomy may not sufficiently capture subpopulations of rural residents at greater risk for cancer and cancer-related mortality.

Using Intervention Mapping to Develop a Theory-Based Intervention to Promote Colorectal Cancer Screening in Egypt.

BACKGROUND: Colorectal cancer (CRC) incidence and mortality rates are increasing in Egypt. Because no national screening guidelines exist, developing an effective evidence-based screening intervention could lower rates by early detection of pre-cancerous and cancerous lesions and polyps. This paper describes the development of a CRC screening intervention in Alexandria, Egypt using Intervention Mapping (IM). MATERIALS AND METHODS: Between September 2019 and March 2020, the successive steps of the IM process were completed. Beginning with the needs assessment, we conducted a literature review, held focus groups with residents of Alexandria, and conducted interviews with local gastroenterologists and oncologists. Program objectives and target audience were determined before designing the program components and implementation plan. Using the PRECEDE-PROCEED theoretical model, predisposing, reinforcing, and enabling screening barriers were assessed. Finally, we developed a Standard Operating Procedures manual detailing aspects of the intervention and evaluation to serve as a model for an expanded screening program. RESULTS: The needs assessment, e.g., literature review, seven focus groups (N=61 participants) and interviews (N=17 participants), indicated that barriers among residents included CRC knowledge deficits, fear/anxiety regarding testing, high cost, and lack of accessibility. Physicians believed CRC testing should only be performed for high risk individuals. Findings from each step of the process informed successive steps. Our final intervention consisted of training components for medical students (Health Champions) who would deliver the intervention to patients in primary care waiting rooms, providing short descriptions of CRC risks and screening, educational brochures, and distributing vouchers for no-cost guaiac fecal occult blood test kits. Health Champions would then follow up with the patients, providing results and referrals for no-cost colonoscopy testing for those with abnormal results. CONCLUSION: Utilizing the IM steps successfully led to development of a theory-based CRC screening intervention for Egypt. Next steps include the implementation of a feasibility pilot intervention.

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers.

BACKGROUND: Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. METHODS: Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. DISCUSSION: Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04000880 . Registered 27 June 2019.