BACKGROUND: Tools are lacking to assess the individual risk of severe toxicity from chemotherapy. Such tools would be especially useful for older patients, who vary considerably in terms of health status and functional reserve. METHODS: The authors conducted a prospective, multicentric study of patients aged !70 years who were starting chemotherapy. Grade 4 hematologic (H) or grade 3/4 nonhematologic (NH) toxicity according to version 3.0 of the Common Terminology Criteria for Adverse Events was defined as severe. Twenty-four parameters were assessed. Toxicity of the regimen (Chemotox) was adjusted using an index to estimate the average per-patient risk of chemotherapy toxicity (the MAX2 index). In total, 562 patients were accrued, and 518 patients were evaluable and were split randomly (2:1 ratio) into a derivation cohort and a validation cohort. RESULTS: Severe toxicity was observed in 64% of patients. The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score was constructed along 2 subscores: H toxicity and NH toxicity. Predictors of H toxicity were lymphocytes, aspartate aminotransferase level, Instrumental Activities of Daily Living score, lactate dehydrogenase level, diastolic blood pressure, and Chemotox. The best model included the 4 latter predictors (risk categories: low, 7%; medium-low, 23%; medium-high, 54%; and high, 100%, respectively; P trend < .001). Predictors of NH toxicity were hemoglobin, creatinine clearance, albumin, selfrated health, Eastern Cooperative Oncology Group performance, Mini-Mental Status score, Mini-Nutritional Assessment score, and Chemotox. The 4 latter predictors provided the best model (risk categories: 33%, 46%, 67%, and 93%, respectively; P trend < .001). The combined risk categories were 50%, 58%, 77%, and 79%, respectively; P trend < .001). Bootstrap internal validation and independent sample validation demonstrated stable risk categorization and P trend < .001. CONCLUSIONS: The CRASH score distinguished several risk levels of severe toxicity. The split score discriminated better than the combined score. To the authors' knowledge, this is the first score systematically integrating both chemotherapy and patient risk for older patients and has a potential for future clinical application. Cancer 2012;118:3377-

The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR [BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment.Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. Patients and MethodsA total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. ResultsResults demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P , .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC). ConclusionThe MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes.

Name and URL of Registry: ClinicalTrials.gov. Registration number: NCT01177124.

To investigate prevalence and severity of symptoms and symptom clustering in breast cancer survivors who attended MBSR(BC). Women were randomly assigned into MBSR(BC) or Usual Care (UC). Eligible women were ≥ 21 years, had been diagnosed with breast cancer and completed treatment within 18 months of enrollment. Symptoms and interference with daily living were measured pre- and post-MBSR(BC) using the M.D. Anderson Symptom Inventory. Symptoms were reported as highly prevalent but severity was low. Fatigue was the most frequently reported and severe symptom among groups. Symptoms clustered into 3 groups and improved in both groups. At baseline, both MBSR(BC) and the control groups showed similar mean symptom severity and interference; however, after the 6-week post-intervention, the MBSR(BC) group showed statistically-significant reduction for fatigue and disturbed sleep (P < 0.01) and improved symptom interference items, compared to the control group. For the between-group comparisons, 11 of 13 symptoms and 5 of 6 interference items had lower means in the MBSR(BC) condition than the control condition. These results suggest that MBSR(BC) modestly decreases fatigue and sleep disturbances, but has a greater effect on the degree to which symptoms interfere with many facets of life. Although these results are preliminary, MBSR intervention post-treatment may effectively reduce fatigue and related interference in QOL of breast cancer survivors.

Implicit measures assess the influence of past experience on present behavior in the absence of respondents’ awareness of that influence. Application of implicit measurement to expectancy and related alcohol cognition research has helped elucidate the links between alcohol-related experiences, the functioning of alcohol-related memory, and alcohol-related behavior. Despite these advances, a coherent picture of the role of implicit measurement has been difficult to achieve due to the diversity of implicit measures used. Two central questions have emerged: do implicit measures assess a distinct aspect of the alcohol associative memory domain not accessible via explicit measurement; and, when compared to explicit measurement, do they offer unique prediction of alcohol consumption? To the end of addressing these questions, a meta-analysis of studies using both implicit and explicit measures of alcohol expectancy and other types of alcohol-related cognition is conducted. Results indicate that implicit and explicit measures are weakly related, and while they predict some shared variance in drinking, each also contributes a unique component. Results are discussed in the context of the theoretical distinction made between the two types of measures.

Mindfulness-based stress reduction (MBSR) reduces symptoms of depression, anxiety, and fear of recurrence among breast cancer (BC) survivors. However, the effects of MBSR (BC) on telomere length (TL) and telomerase activity (TA), known markers of cellular aging, psychological stress, and disease risk, are not known. This randomized, wait-listed, controlled study, nested within a larger trial, investigated the effects of MBSR (BC) on TL and TA. BC patients (142) with Stages 0–III cancer who had completed adjuvant treatment with radiation and/or chemotherapy at least 2 weeks prior to enrollment and within 2 years of completion of treatment with lumpectomy and/or mastectomy were randomly assigned to either a 6-week MBSR for BC program or a usual care. Assessments of TA and TL were obtained along with psychological measurements at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) program. The mean age of 142 participants was 55.3 years; 72% were non-Hispanic White; 78% had Stage I or II cancer; and 36% received both chemotherapy and radiation. In analyses adjusted for baseline TA and psychological status, TA increased steadily over 12 weeks in the MBSR(BC) group (approximately 17%) compared to essentially no increase in the control group (approximately 3%, p < .01). In contrast, no between-group difference was observed for TL (p = .92). These results provide preliminary evidence that MBSR(BC) increases TA in peripheral blood mononuclear cells from BC patients and have implications for understanding how MBSR(BC) may extend cell longevity at the cellular level.

These results provide preliminary support that the mMBSR(BC) program may be feasible and acceptable, showing a clinical impact on decreasing psychological and physical symptoms. This mobile-based program offers a delivery of a standardized MBSR(BC) intervention to BCS that is convenient for their own schedule while decreasing symptom burden in the survivorship phase after treatment for breast cancer.

Objectives To investigate the mechanism(s) of action of MBSR(BC) including reductions in fear of recurrence and other potential mediators. Methods Eighty-two post-treatment breast cancer survivors (stages 0-III) were randomly assigned to a 6-week MBSR(BC) program (n=40) or to Usual Care group (UC) (n=42). Psychological and physical variables were assessed as potential mediators at baseline and at 6 weeks. Results MBSR(BC) compared to UC experienced favorable changes for five potential mediators: (i) change in fear of recurrence problems mediated the effect of MBSR(BC) on 6-week change in perceived stress (z=2.12, p=0.03) and state anxiety (z=2.03, p=0.04); and (ii) change in physical functioning mediated the effect of MBSR(BC) on 6-week change in perceived stress (z=2.27, p=0.02) and trait anxiety (z=1.98, p=0.05). Conclusions MBSR(BC) reduces fear of recurrence and improves physical functioning which reduces perceived stress and anxiety. Findings support the beneficial effects of MBSR(BC) and provide insight into the possible cognitive mechanism of action.