Effects of a multicomponent physical activity behavior change intervention on fatigue, anxiety, and depressive symptomatology in breast cancer survivors: randomized trial.

OBJECTIVES: To determine the effects of the 3-month multicomponent Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) physical activity behavior change intervention on fatigue, depressive symptomatology, and anxiety. METHODS: Postprimary treatment breast cancer survivors (n = 222) were randomized to BEAT Cancer or usual care. Fatigue Symptom Inventory and Hospital Anxiety and Depression Scale were assessed at baseline, postintervention (month 3; M3), and follow-up (month 6; M6). RESULTS: Adjusted linear mixed-model analyses demonstrated significant effects of BEAT Cancer vs usual care on fatigue intensity (M3 mean between group difference [M] = -0.6; 95% confidence interval [CI] = -1.0 to -0.2; effect size [d] = -0.32; P = .004), fatigue interference (M3 M = -0.8; CI = -1.3 to -0.4; d = -0.40; P < .001), depressive symptomatology (M3 M = -1.3; CI = -2.0 to -0.6; d = -0.38; P < .001), and anxiety (M3 M = -1.3; CI = -2.0 to -0.5; d = -0.33; P < .001). BEAT Cancer effects remained significant at M6 for all outcomes (all P values <.05; d = -0.21 to -.35). Clinically meaningful effects were noted for fatigue intensity, fatigue interference, and depressive symptomatology. CONCLUSIONS: BEAT Cancer reduces fatigue, depressive symptomatology, and anxiety up to 3 months postintervention in postprimary treatment breast cancer survivors. Further study is needed to determine sustainable methods for disseminating and implementing the beneficial intervention components.

Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis.

BACKGROUND: Most breast cancer survivors do not meet physical activity recommendations. Understanding mediators of physical activity behavior change can improve interventions designed to increase physical activity in this at-risk population. PURPOSE: Study aims were to determine the 3-month Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention effects on social cognitive theory constructs and the mediating role of any changes on the increase in accelerometer-measured physical activity previously reported. METHODS: Post-treatment breast cancer survivors (N = 222) were randomized to BEAT Cancer or usual care. Assessments occurred at baseline, 3 months (M3), and 6 months (M6). Adjusted linear mixed model analysis of variance determined intervention effects on walking self-efficacy, outcome expectations, goal setting, and perceived barrier interference at M3. Path analysis determined mediation of intervention effects on physical activity at M6 by changes in social cognitive constructs during the intervention (i.e., baseline to M3). RESULTS: BEAT Cancer significantly improved self-efficacy, goals, negative outcome expectations, and barriers. Total path analysis model explained 24 % of the variance in M6 physical activity. There were significant paths from randomized intervention group to self-efficacy (ß = 0.15, p < .05) and barriers (ß = -0.22, p < .01). Barriers demonstrated a borderline significant association with M6 physical activity (ß = -0.24, p = .05). No statistically significant indirect effects were found. CONCLUSIONS: Although BEAT Cancer significantly improved social cognitive constructs, no significant indirect effects on physical activity improvements 3 months post-intervention were observed (NCT00929617).

Effects of a multicomponent physical activity behavior change intervention on breast cancer survivor health status outcomes in a randomized controlled trial.

Little is known about the effects of physical activity behavior change interventions on health outcomes such as lower extremity dysfunction and SF-36 physical health (predictor of mortality) in breast cancer survivors. Furthermore, effect moderators are rarely reported. Therefore, we report the effects of the 3-month BEAT Cancer physical activity behavior change intervention on global health status and health indicators along with moderators of intervention outcomes. Postprimary treatment breast cancer survivors (n = 222) were randomized to BEAT Cancer or usual care (UC). SF-36, muscle strength, body mass index, lower extremity dysfunction (WOMAC), and life satisfaction were measured at 3 months (M3) and 6 months (M6). At M3, adjusted linear mixed-model analyses demonstrated statistically significant effects of BEAT Cancer versus UC on SF-36 physical health [mean between-group difference (M) = 2.1; 95 % confidence interval (CI) 0.3-3.9; p = 0.023], SF-36 mental health (M = 5.2; CI 2.8-7.6; p < 0.001), and all SF-36 subscores. Intervention benefits occurred for lower extremity physical dysfunction (M = -2.7; CI -5.0 to -0.5; p = 0.018), WOMAC total (M = -3.7; CI -6.7 to -0.6; p = 0.018), and life satisfaction (M = 2.4; CI 0.9-3.9; p = 0.001). Statistically significant effects persisted at M6 for mental health and vitality. Baseline value, income, marital status, cancer treatment, cancer stage, and months since diagnosis moderated one or more outcomes. BEAT Cancer improves SF-36, WOMAC, and life satisfaction outcomes with improvements in vitality and mental well-being continuing 3 months postintervention. Several moderators with potential to guide targeting individuals for optimal intervention benefit warrant further study.

Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial.

Most breast cancer survivors (BCS) are not meeting recommended physical activity guidelines. Here, we report the effects of the Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention on physical activity, aerobic fitness, and quality of life (QoL). We randomized 222 post-primary treatment BCS to the 3-month intervention (BEAT Cancer) or usual care (UC). BEAT Cancer combined supervised exercise, face-to-face counseling, and group discussions with tapering to home-based exercise. Assessments at baseline, immediately post-intervention (month 3; M3), and 3 months post-intervention (month 6; M6) included accelerometer and self-reported physical activity, submaximal treadmill test, and QoL [Functional Assessment of Cancer Therapy (FACT)-Breast scale]. Adjusted linear mixed-model analyses demonstrated significant effects of BEAT Cancer compared to UC on weekly minutes of ≥ moderate intensity physical activity at M3 by accelerometer [mean between group difference (M) = +41; 95 % confidence interval (CI) = 10-73; p = 0.010] and self-report (M = +93; CI = 62-123; p < 0.001). Statistical significance remained at M6 for self-reported physical activity (M = +74; CI = 43-105; p < 0.001). BEAT Cancer participants were significantly more likely to meet physical activity recommendations at both time points [accelerometer M3 adjusted odds ratio (OR) = 2.2; CI = 1.0-4.8 and M6 adjusted OR = 2.4; CI = 1.1-5.3; self-report M3 adjusted OR = 5.2; CI = 2.6-10.4 and M6 adjusted OR = 4.8; CI = 2.3-10.0]. BEAT Cancer significantly improved fitness at M6 (M = +1.8 ml/kg/min; CI = 0.8-2.8; p = 0.001) and QoL at M3 and M6 (M = +6.4; CI = 3.1-9.7; p < 0.001 and M = +3.8; CI = 0.5-7.2; p = 0.025, respectively). The BEAT Cancer intervention significantly improved physical activity, fitness, and QoL with benefits continuing 3 months post-intervention.

Inflammation and psychosocial factors mediate exercise effects on sleep quality in breast cancer survivors: pilot randomized controlled trial.

OBJECTIVE: To improve mechanistic understanding, this pilot randomized controlled trial examined mediators of an exercise intervention effects on sleep in breast cancer survivors (BCS). METHODS: Forty-six postmenopausal BCS (≤Stage II, off primary treatment) were randomized to a 3-month exercise intervention or control group. Intervention included 160 min/week of moderate intensity aerobic walking, twice weekly resistance training (resistance bands), and six discussion groups (to improve adherence). Blinded assessments at baseline and post-intervention included sleep disturbance (PSQI and PROMIS®), objective sleep quality (accelerometer), serum cytokines, accelerometer physical activity, cardiorespiratory fitness, body composition, fatigue, and psychosocial factors. Mediation was tested using Freedman-Schatzkin difference-in-coefficients tests. RESULTS: When compared with control, the intervention group demonstrated a significant increase in PSQI sleep duration (i.e., fewer hours of sleep/night) (d = 0.73, p = .03). Medium to large but non-significant standardized effect sizes were noted for PSQI daytime somnolence (d = -0.63, p = .05) and accelerometer latency (d = -0.49, p = .14). No statistically significant mediators were detected for PSQI sleep duration score or accelerometer latency. Daytime somnolence was mediated by tumor necrosis factor-alpha (mediated 23% of intervention effect, p < .05), interleukin (IL)-6:IL-10 (16%, p < .01), IL-8:IL-10 (26%, p < .01), and fatigue (38%, p < .05). Mediating or enhancing relationships for several of the sleep outcomes were noted for accelerometer physical activity, PROMIS® fatigue, exercise social support, and/or physical activity enjoyment. CONCLUSIONS: Inflammation and psychosocial factors may mediate or enhance sleep response to our exercise intervention. Further study is warranted to confirm our results and translate our findings into more effective interventions aimed at improving sleep quality in BCS.

Biobehavioral factors mediate exercise effects on fatigue in breast cancer survivors.

PURPOSE: This study aimed to examine mediators of fatigue response to an exercise intervention for breast cancer survivors in a pilot randomized controlled trial. METHODS: Postmenopausal breast cancer survivors (n = 46; ≤stage 2), off primary treatment, and reporting fatigue and/or sleep dysfunction were randomized to a 3-month exercise intervention (160 min·wk of moderate-intensity aerobic walking, twice weekly resistance training with resistance bands) or control group. Six discussion group sessions provided behavioral support to improve adherence. Fatigue, serum cytokines, accelerometer physical activity, cardiorespiratory fitness, sleep dysfunction, and psychosocial factors were assessed at baseline and 3 months. RESULTS: The exercise intervention effect sizes for fatigue were as follows: fatigue intensity d = 0.30 (P = 0.34), interference d = -0.38 (P = 0.22), and general fatigue d = -0.49 (P = 0.13). Using the Freedman-Schatzkin difference-in-coefficients tests, increase in fatigue intensity was significantly mediated by interleukin 6 (IL-6) (82%), IL-10 (94%), IL-6/IL-10 (49%), and tumor necrosis factor-α (TNF-α):IL-10 (78%) with reduced sleep dysfunction increasing the relationship between intervention and fatigue intensity rather than mediating intervention effects (-88%). Decrease in fatigue interference was mediated by sleep dysfunction (35%), whereas IL-10 and pro-anti-inflammatory cytokine ratios increased the relationship between intervention and interference (-25% to -40%). The reduction in general fatigue was significantly mediated by minutes of physical activity (76%), sleep dysfunction (45%), and physical activity enjoyment (40%), with IL-10 (-40%) and IL-6/IL-10 (-11%) increasing the intervention-fatigue relationship. In the intervention group, higher baseline fatigue, anxiety, depression, and perceived exercise barrier interference predicted a greater decline in fatigue interference and/or general fatigue during the intervention. CONCLUSIONS: Biobehavioral factors mediated and enhanced intervention effects on fatigue, whereas psychosocial factors predicted fatigue response. Further study is warranted to confirm our results and to improve understanding of relationships that mediate and strengthen the intervention-fatigue association.

Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods.

Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating physical activity behavior change. Here, we report the rationale, design, and methods for a two-site, randomized controlled trial comparing the effects of the BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. Secondary aims include examining social cognitive theory mechanisms of physical activity behavior change and health benefits of the intervention. Study recruitment goal is 256 breast cancer survivors with a history of ductal carcinoma in situ or Stage I, II, or IIIA disease who have completed primary cancer treatment. Outcome measures are obtained at baseline, 3 months (i.e., immediately post-intervention), 6 months, and 12 months and include physical activity, psychosocial factors, fatigue, sleep quality, lower extremity joint dysfunction, cardiorespiratory fitness, muscle strength, and waist-to-hip ratio. Confirming behavior change effectiveness, health effects, and underlying mechanisms of physical activity behavior change interventions will facilitate translation to community settings for improving the health and well-being of breast cancer survivors.