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Background: Disease-specific quality of life (QOL) is consistently regarded as one of the most important outcomes by women with metastatic breast cancer (mBC), and it predicts survival. ...Treatment-related symptoms such as cognitive impairment greatly impact QOL in women with mBC. Patients undergoing treatment for breast cancer are highly interested in diet and nutrition, but despite this high level of interest, very few trials have tested dietary interventions in women receiving systemic breast cancer therapy and; the majority of research has been conducted in survivors who have completed primary treatment. Given the limited treatment options for cognitive impairment we evaluated whether our results show a whole food plant based (WFPB) dietary intervention might improve perceived cognitive function (CF) in women undergoing treatment for metastatic breast cancer. Methods: Patients with stage 4 breast cancer receiving treatment were randomized 2:1 into 2 arms: 1) WFPB diet (n = 20) or 2) usual care (n = 10) for 8 weeks with assessments at baseline, and 8 weeks. Our WFPB diet consisted of an ad libitum whole-food, plant-based diet; 3 meals/day were provided, which included fruits, vegetables, whole grains, nuts/seeds and excluded meat, dairy, eggs, added oils, solid fats and most sugars. Patient reported outcomes for perceived CF were collected using FACT- COG and EORTC-QLQ-C30. Paired t-tests were used to assess within group changes from baseline to week 8. The between group difference (WFPB diet vs control) was assessed by ANCOVA model. Results: Patients on the WFPB diet began with a mean baseline score of 140.8 on the FACT-COG which significantly improved to 156.6 (p = 0.005) at 8-weeks post intervention. The reported minimally important difference (MID) between groups is (9.6) and we observed a clinically significant difference of 17.1 (p = 0.03). Similar results in CF were observed for EORTC-QLQ-C30. The baseline mean score of 73.3 was improved to 84.7 (p = 0.004) at 8-weeks post intervention. The reported MID between groups is (4) and we observed a clinically significant difference of 12.6 (p = 0.07), with no significant changes in perceived CF for the control group. Conclusions: Our 8-week WFPB diet resulted in clinically meaningful and statistically significant improvements in perceived cognitive function in women with metastatic breast cancer. A phase 3 clinical trial is needed to confirm the results of this novel intervention. Funding: 3UG1CA189961. Clinical trial information: NCT03045289 .Table: see text
1517 Background: Americans who identify as lesbian, gay, bisexual, transgender, or other sexual and/or gender expansive identities (LGBTQ+) represent approximately 24.2 million (7.2%) people, living ...in the United States. Those who identify as LGBTQ+ face distinct barriers to preventing and treating cancer. In a recently convened ASCO steering committee meeting, reducing LGBTQ+ discrimination both within and outside the healthcare setting was discussed as a high priority area. Across generations, adults who openly identify as LGBTQ+ has increased, with nearly 20% of younger generations identifying as LGBTQ+. This shift in willingness to openly identify as LGBTQ+ may result from decreased discrimination felt by younger generations. Decreasing discrimination may ultimately help improve cancer-care engagement among people who identify as LGBTQ+. Methods: Utilizing a mixed method sequential approach, we examined a national sample of 60 LGBTQ+ cancer survivors’ online quantitative survey data including experiences of discrimination. We performed a t-test to compare young adults (22-39 years old) to adults (40+ years old). Next, we conducted in-depth interviews with ten individuals from as a subset of the 60 cancer survivors. The transcribed data was analyzed using constant comparative methods and sorted into themes. Results: Among the 60 survey respondents, 31 (51.7%) were 40+ years old. Majority of the survey respondents were White (n = 55, 88.3%), ciswomen (n = 40, 66.7%), and identified as bisexual (n = 20, 33.3%). The subset of in-depth interview participants shared similar demographics. Quantitative: The adult cancer survivors reported experiencing higher levels of discrimination than younger adult cancer survivors (Mean Difference = 5.82, 95% CI 1.11, 10.54). Qualitative: Among the adult cancer survivors (k = 8), three endorsed the theme of “discrimination”. While one of the young adult cancer survivors (k = 2), endorsed the theme of “identity pride” defined as satisfaction from and immersion within their LGBTQ+ identity. Mixed Methods: Both quantitative and qualitative data confirmed that adult cancer survivors experienced significant differences in discrimination compared to the younger adult cancer survivors. Within the adult cancer survivor interviews, historical experiences such as the AIDS epidemic led to discriminatory experiences and ongoing medical mistrust. Among younger adult cancer survivors, openly embracing their identities and engaging with the healthcare system was described. These disparities may explain the variation in levels of reported discrimination. Conclusions: Research shows discrimination has a profound impact on whether a person identifying as LGBTQ+ will seek out cancer-related care. Therefore, reducing discrimination for people who identify as LGBTQ+ is crucial to reducing cancer disparities.
12023
Background: Older cancer survivors consistently express the need for interventions to reduce fatigue and maintain quality of life (QOL). We previously showed that yoga, compared to standard ...care, effectively improved fatigue and QOL among older survivors. Whether yoga is superior to a rigorous behavioral placebo for improving fatigue and QOL in older survivors is unknown. To examine the efficacy of yoga vs a behavioral placebo for improving fatigue and QOL in older survivors. Methods: Older cancer survivors (age 60+) 2-60 months post-treatment were randomized to receive Yoga for Cancer Survivors (YOCAS; 75-minute sessions 2x/week for 4 weeks) or a behavioral placebo (Survivorship Health Education – SHE; 75-minute sessions 2x/week for 4 weeks). The YOCAS
intervention includes breathing exercises, yoga poses, and mindfulness activities. The SHE
placebo includes education based on ASCO cancer survivorship recommendations. Fatigue and QOL (i.e., overall, physical, emotional, and functional) were assessed pre- and post-intervention with the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). The within-group and between-group intervention effects on fatigue were examined by 2-tailed t tests and ANCOVAs. Results: 173 older survivors were enrolled (91% women, mean age 67 range=60-85, 90% White, 10% racial minority, 2.3% Hispanic, 71% breast cancer). On average, participants completed 6 in-person yoga sessions and 1 additional weekly, home-based yoga practice, for an average of 183 minutes of yoga/week with no intervention-related adverse events. There were significant between group differences on fatigue, where yoga participants reported significantly more improvement in fatigue than controls (1.6±0.9, p<0.05). There were also significant between group differences on the emotional component of QOL, where yoga participants reported significant improvement in the emotional component of QOL but controls did not (0.8±0.4, p<0.045). Moreover, there were statistical trends for between group differences on the physical and functional component of QOL, where yoga participants reported improvements in the physical (0.8±0.4, p<0.063) and functional components of QOL (0.9±0.5, p<0.089) but controls did not. There were significant between group differences on overall QOL, where yoga participants reported significant improvement in overall QOL but controls did not (3.8±1.4, p<0.007). 94% of participants reported the intervention useful for symptom management and would recommend it to others. Conclusions: Results suggest that older survivors: 1) can safely utilize yoga for treating side effects, 2) experience improvements in fatigue and QOL via yoga therapy, and 3) find yoga a useful treatment for side effects and recommend it to others. Future research is needed to confirm these results and increase uptake by older, and ethnically and racially diverse survivors. Clinical trial information: NCT02613364 .
12015 Background: Cancer-related fatigue (CRF) often co-occurs with insomnia and both are incapacitating adverse toxicities of cancer and its treatment which may persist months and years after the ...completion of treatment. Yoga and Cognitive Behavioral Therapy for Insomnia (CBT-I) are promising behavioral approaches for improving CRF and insomnia among cancer survivors. However, the influence of changes in insomnia resulting from participating in yoga or CBT-I on the subsequent changes in CRF is not fully understood. Methods: We conducted mediation analyses on data collected from a multicenter phase III RCT among cancer survivors who were randomized to receive 1) Yoga for Cancer Survivors (YOCAS, 75-min./session, 2x/wk. for 4 wks.), 2) CBT-I (90-min./session, 1x/wk. for 8 wks.), or 3) a behavioral placebo (ASCO recommended Survivorship Education, 75-min/session, 2x/wk. for 4 wks.). Brief Fatigue Inventory and Insomnia Severity Index were used to assess CRF and insomnia, respectively, at pre-, mid-, and post-intervention. Causal mediation analyses were conducted to estimate the influence of changes in insomnia at mid-intervention resulting from participating in YOCAS, CBT-I, or behavioral placebo on subsequent changes in CRF at post-intervention. Results: 550 survivors (93% female; mean age 57 years; 75% were breast cancer survivors) completed baseline and post-intervention assessments. YOCAS, compared to placebo, significantly improved CRF and insomnia at mid-intervention (CRF: -0.38±0.16, p = 0.01; Insomnia: -1.15±0.35, p < 0.01) and post-intervention (CRF: -0.35±0.17, p = 0.03; Insomnia: -1.43±0.41, p < 0.01). Among YOCAS participants, improvement in insomnia at mid-intervention significantly influenced the subsequent reduction in CRF (-0.14±0.06, p = 0.01) and accounted for 37% (95% CI: 0% - 78%) of the total reduction in CRF at post-intervention. CBT-I, compared to placebo, also significantly improved CRF and insomnia at mid- (CRF: -0.32±0.18, p = 0.06; Insomnia: -2.64±0.40, p < 0.01) and post-intervention (CRF: -0.59±0.18, p < 0.01; Insomnia: -4.95±0.46, p < 0.01). Among CBT-I participants, the improvement in insomnia at mid-intervention significantly influenced the subsequent reduction in CRF (-0.40±0.09, p < 0.01) and accounted for 60% (95% CI: 21% - 99%) of the total reduction in CRF at post-intervention. Conclusions: Both YOCAS and CBT-I effectively improve CRF and insomnia among survivors. 37%-60% of the reduction in CRF resulting from participating in YOCAS or CBT-I is due to improvement in insomnia. Clinicians should consider prescribing YOCAS yoga or CBT-I for survivors who experience CRF and insomnia. Clinical trial information: NCT02613364 .
12008 Background: Exercise is recommended by ASCO as a treatment for cancer-related fatigue (CRF) - one of the most pervasive toxicities patients with breast cancer experience. Current oncology ...guidelines recommend aerobic exercise (e.g., walking) at a weekly dose of 150 minutes of moderate intensity or 75 minutes of vigorous intensity. While these recommendations exist and are effective for treating CRF, patients with breast cancer struggle to achieve these levels of exercise, especially at a vigorous intensity during chemotherapy. The purpose of this study was to determine the doses of low and moderate intensity walking required to elicit a clinically meaningful reduction in CRF. Methods: As part of a nationwide prospective cohort study, 580 female breast cancer patients (stage I-IIIC; receiving chemotherapy) were recruited from 19 University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) Research Base locations. CRF (Multidimensional Fatigue Symptom Inventory) and exercise dose (i.e., walking via ACLS Physical Activity Measure) were measured at pre-chemotherapy, 1-month post-chemotherapy, and 6-months post-chemotherapy. Exercise dose was measured in METs (energy expenditure normalized for body weight and time; 1 MET = 1 kcal/kg/hr) and converted into walking time (minutes) and intensity (mph). A low-intensity walking pace is < 2.5mph (< 3 METs), and a moderate-intensity walking pace is 2.6-4.5mph (3.1-6 METs). Results: Pre-chemotherapy, patients with breast cancer averaged walking 40-60 minutes/week at a low intensity or 20-38 minutes/week at a moderate intensity (median: 2.0 MET hrs/wk). Linear mixed modeling demonstrated a higher amount of walking significantly predicts lower CRF at all three time points (β: -0.26, SE: 0.08; p < 0.001). Logistic regression identified that patients who increase their walking by 111-162 minutes at a low-intensity pace or 54-108 minutes at a moderate-intensity pace (i.e., 1 SD) are 43% more likely to experience a clinically meaningful reduction in CRF (- 4.5 MFSI total) from pre-chemotherapy to 1-month post-chemotherapy (SD: 5.4 MET hrs/wk; OR: 1.43, 95% CI: 1.19-1.72; p < 0.001). Conclusions: Over the course of chemotherapy, patients with breast cancer who can increase their walking at a low intensity pace (< 2.5 mph) up to 151-222 min/wk or at a moderate intensity pace (2.6-4.5 mph) up to 74-146 min/wk are 43% more likely to have clinically meaningful lower levels of CRF post-chemotherapy.
The United States (US) has a rapidly aging population. As such, research into the prevention of chronic degenerative diseases of aging such as osteoporosis and sarcopenia are critical for improving ...the quality of life of older US adults. Recent preclinical studies have provided evidence for an estrogen-independent pathway through which pituitary-derived follicle stimulating hormone (FSH) acts on bone and muscle in postmenopausal women. We evaluated the cross-sectional and longitudinal associations of FSH and bone mineral density, bone-related outcomes, and lean soft tissue in a sample of 675 healthy postmenopausal women. The first aim of this study was to evaluate the cross-sectional association of serum FSH concentration with prevalent low bone mass and osteoporosis. In logistic regression models, adjusted for age, menopausal hormone therapy use, total body fat mass, and diabetes, women with the highest baseline FSH had increased odds of low bone mass and osteoporosis compared to women with the lowest baseline FSH concentration. Stratified analyses provided evidence of effect modification according to serum estradiol concentration. A mediation analysis indicated that FSH mediates the established estradiol-bone relationship. These results suggest an inverse association between FSH and bone mineral density, especially among women with lower estradiol, and support our novel hypothesis that FSH mediates the E2-bone relationship. The second aim of this dissertation was to evaluate the association of baseline serum FSH and 5-year BMD change. There was no statistically significant association of baseline FSH predicting 5-year BMD change following adjustment for age, 5-year change in total body fat mass, change in menopausal hormone therapy use, and the respective baseline BMD measure. The third aim investigated the relationship of both baseline FSH and 5-year FSH change with incident fracture (total fracture or major osteoporotic fracture) over an average 10 and 15 years of follow-up, respectively. In survival analyses adjusted for age, serum testosterone, diabetes status, and change in menopausal HT use over follow-up, there was no significant association of either baseline FSH or FSH change and total fracture. However, among a subsample of women who are within 10 years of starting menopause, using women with comparatively stable FSH over a 5-year period as the referent group (Tertile 2 of FSH change), women who experienced decreasing FSH concentration (those in the first tertile of 5-year FSH change) had significantly lower risk of fracture over 15 years of follow-up These findings suggest that a more relevant window of exposure in the FSH-bone relationship may be closer to the menopausal transition (perimenopause or early post menopause).Finally, the fourth aim was to analyze the cross-sectional and longitudinal relationship between FSH and lean soft tissue measures (whole-body DXA derived lean soft tissue and appendicular skeletal muscle index). In the cross-sectional analyses, there was a significant inverse association of FSH and both lean soft tissue measures following adjustment for age, estradiol level, change in estradiol over follow-up, DXA derived total body fat mass, physical activity, and the respective baseline DXA lean soft tissue measures. In longitudinal analyses, while baseline FSH did not significantly predict 5-year lean soft tissue change, there was a significant inverse association of 5-year FSH change and 5-year lean soft tissue change. These results suggest an inverse association of FSH and muscle measures in healthy postmenopausal women. Overall, data from cross-sectional analyses support an inverse association between higher FSH and increased odds of prevalent low bone mass and osteoporosis. We also report compelling evidence for our novel hypothesis that FSH may play a mediating role in the estrogen-bone relationship. These cross-sectional results did not translate to significant findings in longitudinal analyses of baseline FSH and 5-year BMD change or incident fracture over 10 and 15 years of follow-up, respectively, except in women within 10 years since menopause. Finally, we report consistent cross-sectional and longitudinal evidence of an inverse relationship between FSH and lean soft tissue loss in healthy postmenopausal women. These findings are largely consistent with the preclinical evidence for direct action of FSH on bone and muscle, while the observational evidence in postmenopausal women is conflicting. This is the largest study of FSH with bone and muscle measures reported in postmenopausal women to date. Due to its large sample size of exclusively postmenopausal women and the breadth of information available on aspects of body composition as well as serum hormone measures and hormone therapy use, the OsteoPerio study is uniquely suited to evaluate this research question. Further study of FSH, bone and muscle in more diverse populations closer to the menopausal transition are needed.
1527 Background: Understanding of information needs and information-seeking styles of patients with cancer is critical for shared decision-making and high quality care. Most patients with cancer want ...to be involved in the decision-making process but have unmet information needs regarding their disease and its treatment. The goal of this study is to 1) identify information needs and 2) investigate factors associated with information-seeking styles pre-and-post treatment among patients with cancer. Methods: This is a secondary data analysis of a longitudinal study of 1003 patients from nine community oncology practices across the United States that assessed information needs of patients with cancer. We recruited patients aged ≥18 years with a newly diagnosed cancer. Patients supplied demographic and clinical information at enrollment; information needs assessment including concerns (score ranging, 0-100) and anticipated side effects (0-60), questions on information-seeking styles (1-item), decision-making preferences (1-item), and resource usage (5-items) were obtained within two weeks pre-and-post treatment. We performed multinomial logistic regression to evaluate the association of information needs including concerns, anticipated side effects, and decision-making preferences with information-seeking styles (active vs. passive) at pre-and-post treatment. The analysis was adjusted for age, gender, race, marital status, education, overall health, and cancer and treatment types. Results: Mean age was 60.5 (SD=13.0) years. Most were White (93.0%), female (64.0%), had some college (54.3%), and were diagnosed with breast cancer (47.0%). The sources of health information included friends (52.7%), pamphlets (60.2%), and experts (75.6%). Of the total, 43.8% reported that they preferred shared decision making but had concerns about understanding the diagnosis (70.2%) and treatment plan (70.7%). On logistic regression, preference for shared decision making (vs. doctor making all decisions; Odds Ratio (OR) pre-treatment =1.87, p=.01; OR post-treatment =2.3, p<.001), taking notes while meeting with doctor (vs. not taking notes; OR pre-treatment =2.2, p<0.001; OR post-treatment =1.8, p=0.01), and information sought that could be useful later (vs. not useful; OR pre-treatment = 1.9, p=.03; OR post-treatment =1.3, p=0.38) were associated with greater odds of active information seeking. Education and cancer type (pre-treatment) and age, cancer, and treatment types (post-treatment) were significantly associated with active information seeking. Conclusions: Shared decision making and taking notes during doctor visits are crucial factors associated with active information seeking. Interventions tailored to meet information needs of these patients may help increase patient participation in healthcare decision making.
Evidence from animal studies suggests that the gradual rise in follicle-stimulating hormone (FSH) during reproductive senescence may contribute to the change in adiposity distribution characteristic ...of menopause. The potential independent role the interrelationships of FSH and estradiol (E2) may play in postmenopausal adiposity changes are not well studied.
Our objective was to evaluate the associations of FSH and dual x-ray absorptiometry (DXA)-derived adiposity measures, with consideration of estradiol and postmenopausal hormone therapy use.
In a sample of 667 postmenopausal women from the Women's Health Initiative Buffalo OsteoPerio Ancillary Study, we studied the associations of serum FSH and E2 levels with dual x-ray absorptiometry (DXA)-derived adiposity measures via cross-sectional and longitudinal analyses (5-year follow-up).
In cross-sectional analyses, FSH levels were inversely associated with all measures of adiposity in models adjusted for age, years since menopause, smoking status, pack-years, and hormone therapy (HT) use; these associations were not influenced by adjustment for serum E2. In longitudinal analyses, the subset of women who discontinued HT over follow-up (n = 242) experienced the largest increase in FSH (+33.9 mIU/mL) and decrease in E2 (-44.3 pg/mL) and gains in all adiposity measures in unadjusted analyses. In adjusted analyses, an increase in FSH was associated with a gain in percentage of total body fat, total body fat mass, and subcutaneous adipose tissue (SAT).
While cross-sectional findings suggest that FSH is inversely associated with adiposity, our longitudinal findings suggest that greater increases in FSH were associated with greater increases in percentage of total body fat, total body fat mass, and SAT. Future studies are needed to provide additional insight into FSH-adiposity mechanisms in larger samples.
Summary
We evaluated the influence of two endogenous hormones on bone health in older women. Higher FSH was associated with bone disease, especially in lower estradiol environments. FSH attenuated ...the relationship between estradiol and bone. This may provide a mechanism through which future clinical research intervenes on bone loss.
Introduction/purpose
Despite preclinical evidence for an inverse association of follicle-stimulating hormone (FSH) and bone mineral density (BMD), no large epidemiologic studies have evaluated the separate and joint influences of FSH and estradiol on bone in postmenopausal women.
Methods
In a cross-sectional study of 675 postmenopausal women, we evaluated associations of serum FSH and dual X-ray absorptiometry (DXA)-classified areal BMD as well as low bone mass or osteoporosis (T-score < − 1.0) of the femoral neck and total hip. We stratified this analysis by serum estradiol (cut at the median). We tested whether FSH mediates the association of estradiol and BMD using the Sobel test.
Results
In linear regression models, there was a significant inverse association of serum FSH with both femoral neck and total hip BMD (both
p
< 0.01) when adjusted for age, hormone therapy (HT) use, and diabetes. In fully adjusted logistic regression models, women in the highest FSH tertile had higher odds of low bone mass/osteoporosis at the femoral neck (OR = 2.98; 95% CI = 1.86–4.77) and at the total hip (OR = 1.74; 95% CI = 1.06–2.84) compared to those in the lowest FSH tertile. We report evidence of effect modification by estradiol in stratified models and an interaction term. FSH met all criteria of a mediator, including an estimated 70% attenuation of the estradiol-BMD relationship (Sobel
p
value < 0.001).
Conclusions
FSH is associated with higher odds of having low bone mass/osteoporosis even after accounting for HT use. FSH is a mediator of the relationship between estradiol and BMD in healthy postmenopausal women. Larger, prospective studies of FSH concentrations and bone health are needed.
