Fatigue is the most prevalent and debilitating symptom experienced by breast cancer patients receiving adjuvant chemotherapy or radiation therapy and few evidence-based treatments are available to manage this distressing side-effect. The purpose of this multi-institutional randomized controlled trial was to determine the effects of exercise on fatigue levels during treatment for breast cancer. Sedentary women (N=119) with Stage 0-III breast cancer receiving outpatient adjuvant chemotherapy or radiation therapy were randomized to a home-based moderate-intensity walking exercise program or to usual care for the duration of their cancer treatment. Of participants randomized to exercise, 72% adhered to the exercise prescription; 61% of the usual care group adhered. The intention-to-treat analysis revealed no group differences in part because of a dilution of treatment effect as 39% of the usual care group exercised and 28% of the exercise group did not. When exercise participation was considered using the data analysis method of instrumental variables with principal stratification, a clinically important and statistically significant (p=0.03) effect of exercise on pretest-to-posttest change in fatigue levels was demonstrated. Adherence to a home-based moderate-intensity walking exercise program may effectively mitigate the high levels of fatigue prevalent during cancer treatment.

A home-based walking exercise program is a potentially effective, low-cost, and safe intervention to manage fatigue and to improve QOL during adjuvant chemotherapy or radiation therapy for breast cancer. This health-promoting self-care activity needs further testing in large randomized clinical trials.

BackgroundEstablishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality. The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness.MethodsThis updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration’s review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required.ResultsThe 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs.ConclusionsEvidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on PtDA effectiveness.

A B S T R A C T PurposeWomen at high risk of breast cancer face the complex decision of whether to take tamoxifen or raloxifene for breast cancer chemoprevention. We investigated what is known about decisions of women regarding chemoprevention. MethodsUsing MEDLINE, CINAHL, and PSYCINFO, plus reviewing reference lists of relevant articles, in December 2009 we identified 13 studies that addressed patient decisions about breast cancer chemoprevention, were published in 1995 or later, were peer-reviewed primary clinical studies, and reported rates at which participants showed interest in (hypothetical uptake) or accepted (real uptake) chemoprevention medications. ResultsNine studies provided information about hypothetical breast cancer chemoprevention decisions (mean uptake rate, 24.7%) and five provided information about real decisions (mean uptake rate, 14.8%). The range of rates was wide, and each of the hypothetical uptake studies assessed interest differently. A logistic regression model found significant correlation with uptake of decision type (hypothetical versus real, odds ratio [OR] ϭ 1.65; 95% CI, 1.26 to 2.16), educational or decision support intervention (provided v not, OR ϭ 0.21; 95% CI, 0.17 to 0.27), and cohort risk for breast cancer (high-risk v general population, OR ϭ 0.65; 95% CI, 0.56 to 0.75). Perceived vulnerability to breast cancer was consistently correlated with increased uptake, and concern for adverse effects was correlated with reduced uptake. All studies used a correlational/descriptive design, and most studies used convenience sampling strategies. ConclusionBreast cancer chemoprevention uptake rates are low and variation is wide. Hypothetical uptake rates are higher than real uptake, and interventions markedly reduce uptake. Research is needed that uses reproducible sampling methods and examines decision support strategies that lead to quality decisions.