e24076 Background: Manypatients with cancer receiving hormone therapy experience difficulty with sleeping and insomnia. Reiki is a technique where therapy is delivered to the patient with either no ...or very light physical touch whereas traditional massage therapy uses pressure and movement by the therapist to manipulate soft tissue. Both Reiki and traditional massage therapy have been shown by others to be effective in providing benefits in sleep quality. This study is the first to compare changes in sleep quality after massage and Reiki treatments in patients with prostate and breast cancer receiving hormone therapy. Methods: Eighty-seven, breast (n = 56) and prostate cancer (n = 31), patients receiving hormone therapy experiencing self-reported fatigue ≥4/10were included in this randomized controlled trial (RCT). Patients were randomized into one of three treatment arms for 4-weeks: Arm 1 received two massage treatments, Arm 2 received two Reiki treatments and Arm 3 received four Reiki treatments. Each treatment session was approximately 75 minutes. . Participants with a baseline score of ( ≥8) on the ISI were included in this analysis. Results: 75% of all enrolled participants (n = 65) met the inclusion criteria for baseline clinically meaningful insomnia. Both Reiki and massage provided improvement in sleep quality from pre to post intervention and there was no difference between 2 and 4 Reiki sessions. Reiki significantly increased sleep quality (p > .01) with a mean decrease in total ISI score of 2.96. Massage therapy showed a trend towards improved sleep quality (p = 0.06) with a mean decrease in ISI score of 1.95. There was a clinically meaningful decrease in total ISI score (≥6) in 15% of those who received massage therapy compared to 25% in the reiki therapy group. Conclusions: Four weeks of Reiki significantly improved sleep quality in patients with breast and prostate cancer receiving hormone therapy. Reiki may be a better non-pharmacologic therapeutic for improving sleep quality. Clinical trial information: NCT02758756 .
e24141 Background: Continued smoking throughout cancer treatment, including surgery, is associated with treatment-related complications and a higher total symptom burden during treatment. This can ...lead to interruptions and delays in therapy that can compromise treatment efficacy and survival. Approximately 1 in 3 patients smoke at or around time of cancer diagnosis. Despite this “teachable moment” for smoking cessation, at least half of patients with cancer are unsuccessful in their attempts, and relapse rates for post-surgical cancer patients are high. Better understanding of quit motivation among these patients can help guide tobacco treatment interventions in the post-operative and adjuvant treatment time periods. Methods: This is an analysis of a longitudinal nationwide multicenter study of 1003 patients through the University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) that assessed treatment type, treatment-related symptoms, smoking status, and motivation to quit smoking for patients with a new diagnosis of cancer. Patients supplied demographic and clinical information at enrollment with assessments at two weeks pre- adjuvant treatment, post adjuvant treatment, and 6 months. Chi-square, multinomial logistic regression, and ANOVA were used to analyze the difference between smokers and nonsmokers, and those with previous surgical treatment. Results: The majority of patients had surgery as part of their cancer treatment (n = 718, 71.6%). Of these (n = 222, 30.9%) had a diagnosis of a tobacco-associated cancer, which was associated with smoking status at pre-treatment (p < 0.05). For those with previous surgery, n = 90 (68.7%, p < 0.001) were current smokers before starting adjuvant treatment. Post-surgical patients who smoke had both higher total symptom burden ( M= 23.7 vs M= 17.0; p < 0.05) and higher symptom severity ( M =1.97 vs M= 1.42; p < 0.001) pre-adjuvant treatment and at 6 month follow up ( M =31.3 vs M= 22.2; p < 0.05);( M= 2.6 vs M= 1.8; p < 0.05) compared to post-surgical patients who were not smokers. Motivation to quit was sustained among current smokers between the pre- and post- adjuvant treatment periods (p < 0.001), as well as for those that had previous surgery (p < 0.05). Despite motivation to quit among 64.4% of current smokers with previous surgery, 15.4% reported being able to quit by post-adjuvant treatment with 50% relapsing to smoking at 6-month follow up. Conclusions: For patients that continue to smoke after surgical treatment, cessation rates are much lower than motivation to quit with high rates of relapse. Early intervention around the time of surgery presents an ideal opportunity to optimize the “teachable moment” by providing longitudinal tobacco treatment as part of cancer care to improve treatment-related symptoms, as well as overall survival.
e24033
Background: The Mediterranean Diet (MedDiet) has emerged as an effective health-promoting dietary pattern. It is high in fruit, vegetables, whole grains, fiber, antioxidants, and ...anti-inflammatory compounds. A cancer diagnosis is often seen as a “window of opportunity” for behavior change, yet there are few structured nutritional programs available for patients undergoing active treatment. Herein, we developed a remote MedDiet intervention and identified barriers and facilitators to adherence. Methods: This was a qualitative analysis of the intervention arm of a clinical trial (NCT04534738). Participants had at least 6 weeks of chemotherapy scheduled. The MedDiet intervention was 8 weeks and included home food delivery (frozen meals and fresh ingredients weekly for the first 4 weeks), education, goal-setting, a cookbook, and weekly phone calls with a nutritionist. MedDiet adherence was measured using the MedDiet Adherence questionnaire at baseline, 4 weeks, and 8 weeks; change was assessed using paired t-tests between baseline and 4 and 8 weeks. After the study, participants underwent a semi-structured interview to provide feedback on the intervention. Interviews were transcribed and emergent coding was used to identify themes. Results: Patients (n = 23) were 52.5±13.6 years old, 2 were male, 83% were White, and 87% had breast cancer. MedDiet adherence was 4.0±2.7 at baseline. It increased 2.1±3.2 points from baseline to 4 weeks and 2.5±3.0 from baseline to 8 weeks (both p < 0.001). Interviews were conducted with 21 patients (example quotes in Table). Although most participants (n = 15, 71%) did not seek nutritional information at the time of their diagnosis, most (n = 19, 90%) were highly engaged with the program. In response to an open-ended question, many (n = 11) expressed a sense of empowerment. Facilitators to adherence included structure, accountability, food provision, palatability, and easy procurement of ingredients. Barriers included chemotherapy-induced taste changes and mouth sores, cooking for family members’ preferences, others preparing food for the patient, and higher priority areas for mental energy expenditure. The majority (n = 13, 62%) preferred a program during vs. after cancer treatment. All (21/21) indicated they would continue to follow at least some aspects of the diet. Conclusions: A remote MedDiet intervention was effective and well received by patients undergoing chemotherapy. Future research should investigate how a MedDiet intervention affects clinical outcomes and symptom burden. Clinical trial information: NCT04534738. Table: see text
e24160
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
6544
Background: Our prior research shows that SGM cancer survivors experience high rates of depression, due in part to exposure to discrimination. Depression among cancer survivors in general has ...been linked to markers of systemic inflammation including peripheral blood interleukin (IL)-6, tumor necrosis factor alpha (TNFα), and C-reactive protein (CRP). To date, no studies have examined the association of these markers with depression among SGM cancer survivors in the context of discrimination. Methods: Cross-sectional patient-reported data and serum samples were collected from 66 SGM cancer survivors (see Table). Depression was assessed by the Patient Health Questionnaire (PHQ)-9, discrimination by the Harassment, Rejection, and Discrimination Scale (HHRDS), IL6 and TNFα by multiplex assay, and CRP by ELISA. We used a clinical cut-point for depression of 10 on the PHQ-9, indicating moderate depressive symptoms, and assessed associations between continuous variables using bivariate correlations and multivariate linear regressions. Results: More SGM cancer survivors exceeded the clinical cut-point for depression (15.9%) than cancer survivors in prior general population samples (11.3%). Higher depression among SGM cancer survivors was associated with higher levels of exposure to discrimination (r=0.28, p=0.03), TNFα (r=0.30, p=0.02), and CRP (r=0.39, p=0.002); exposure to workplace discrimination, specifically, was associated with higher levels of CRP (r=0.32, p=0.02). In multivariate models controlling for demographic and clinical characteristics, CRP remained a significant predictor of depression (β=0.34, p=0.01). Conclusions: This study replicates prior findings of high levels of depression among SGM cancer survivors. It provides preliminary evidence that markers of inflammation, specifically CRP, are uniquely predictive of depression among SGM cancer survivors in the context of exposure to discrimination. These findings need to be replicated in larger samples and evaluated for potential use in providing supportive cancer care to SGM survivors. Table: see text
e24116
Background: Obesity rates in the US have increased dramatically in recent years. Breast cancer treatment is associated with additional weight gain, and among patients with breast cancer, ...obesity and weight gain are associated with negative outcomes such as reduced progression-free and overall survival due to cardiometabolic co-morbidities. New evidence suggests that cardiometabolic comorbidities themselves can further accelerate breast cancer progression. We used a WFPB dietary intervention because it results in significant weight loss and larger improvements in cardiometabolic outcomes than a traditional, calorie-restricted omnivore diet. Methods: Patients with stage 4 breast cancer receiving treatment were randomized 2:1 into: 1) a WFPB dietary intervention (N = 19) or 2) usual care (N = 9) for 8 weeks with assessments at baseline, 4, and 8 weeks. Our WFPB diet consisted of education and an ad libitum whole-food, plant-based diet; 3 prepared meals a day were provided to WFPB subjects for the duration of the trial. The diet included fruits, vegetables, whole grains, legumes, nuts/seeds and excluded meat, dairy, and eggs. Outcomes include compliance, weight, cardiometabolic outcomes, and cancer progression markers. Effects of the WFPB on the outcomes were assessed by comparing marginal means by arm estimated at 8 weeks from the analysis of covariance model controlling for baseline. Results: Dietary compliance was high, with 95% of WFPB subjects consuming ≥80% of their calories from on plan foods. The WFPB group (mean baseline BMI = 31.6 kg/m
2
), on average, lost 6.7% (p < 0.01) of their total body weight. Adjusting for baseline weight, the WFPB group lost 8.9 lbs. more (p < 0.01) and 5.8% more of their total body weight (p < 0.01) than the control group. Conclusions: Our WFPB dietary intervention resulted in clinically meaningful and statistically significant improvements in weight and cardiometabolic outcomes, with a trend towards improving a clinically used cancer progression marker. Larger studies with longer interventions are needed to confirm these findings and investigate the sustainability of the benefits. Clinical trial information: NCT03045289. Table: see text
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.
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.
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Background: Older adults with advanced cancer are at increased risk of treatment-related toxicities, which can compromise physical performance and independence in daily functioning. However, ...studies evaluating the relationship of toxicities with functional capacity in this population are scarce. The aim of this analysis is to assess the effect of clinician-reported toxicities (CRTs) and patient-reported symptomatic toxicities (PRSTs) on physical performance and independence in daily functioning. Methods: This is a secondary analysis of GAP 70+ (NCT02054741, n = 718), a cluster randomized trial of older patients (70+ years) with advanced cancer initiating a new systemic therapy regimen. Impairments in physical performance measured by Short Physical Performance Battery (SPPB), and functional independence measured by activities of daily living (ADL), and instrumental ADL (IADL) were classified by established cut points. CRTs were collected by Common Terminology Criteria for Adverse Events (CTCAE) and PRSTs by Patient-Reported Outcome version of CTCAE (PRO-CTCAE). PRST grade was determined by severity of the items (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). To count as a PRST event, symptom severity had to increase from pre-treatment level (baseline adjusted method). Patients without baseline impairment in SPPB, IADL, and ADL (n = 104, 308, 461, respectively), who provided data after baseline were included in the analysis. To assess the association of experiencing toxicity within 3 months and developing functional impairment within 6 months, generalized estimating equation (GEE) modeling was used. Models were adjusted for practice sites (random effect) and the study arm. Results: Patients were 70-96 years old (mean 77), 56% were male, and majority (87%) were white. Gastrointestinal (34%) and lung (25%) were the most common cancer types. During treatment, impairments in SPPB developed in 57.7% (60/104), in IADL 47.4% (146/308), and in ADL 31.0% (143/461). There was no association of CRT grade with developing impairment in SPPB (p = 0.92). A greater proportion of patients who experienced grade ≥ 3 CRT, compared to those with grade 2 and grade ≤ 1 CRT, developed impairment in IADL (54.4 vs 38.3 vs 25.2%, p = 0.01) and also in ADL (34.8 vs 23.9 vs 22.7%, p = 0.02). Patients who experienced grade ≥ 3 PRST, compared to those with grade 2 and grade ≤ 1 PRST, were more likely to developed impaired SPPB (73.6 vs 50.4 vs 27.8%, p = 0.01), IADL (50.8 vs 45.4 vs 31.5%, p = 0.20), and ADL (38.1 vs 18.5 vs 19.7%, p < 0.01). Conclusions: Assessing both patient- and clinician-reported toxicity provides insight into loss of independent functioning. Information patients provide about symptoms can help with early detection of decline in physical performance in older adults. These findings may help to guide interventions to mitigate functional decline. Clinical trial information: NCT02054741.
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Background: Androgen deprivation therapy (ADT) is standard treatment for prostate cancer but may cause changes in body composition that lead to decreased physical function. Low ...vitamin D status is also associated with decreased functionality. The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating functionality. The bioelectrical impedance analysis (BIA) is a portable tool for assessing lean mass and phase angle, a measure of nutrition status and frailty in chronic disease. Methods: This was a secondary analysis of a randomized controlled trial to assess the impact of high dose vitamin D in older patients (≥60 yrs) with prostate cancer on ADT. Patients with prostate cancer (N = 59, age 67.6 ± 5.4) with vitamin D insufficiency ( < 32 ng/ml) were randomized to high-dose vitamin D (n = 29, 600 IU/daily plus 50,000 IU/weekly) or low-dose vitamin D (n = 30, 600 IU/daily plus placebo weekly) for 24 weeks. SPPB tests and BIA were assessed at baseline, 12 weeks and 24 weeks. Phase angle values were calculated using atan(reactance/resistance) x (180°/π). A phase angle value < 5.7° is a valid cutoff for frailty in older men. Results: Serum analyses showed compliance with vitamin D intake (25-OH vitamin D change: high vitamin D = +32.0 ng/ml vs low dose RDA vitamin D = +4.3 ng/ml; p < .01). There were no difference at all three assessments for SPPB or lean mass between arms. The high-dose vitamin D group had wider phase angle values at 12 weeks (5.81º vs. 5.32º; p = .018) and 24 weeks (5.89º vs. 5.40º; p = .030). The low-dose group had phase angle values < 5.7º over the course of the study. At baseline, over 18% of patients had phase angle values below the 10
th
percentile of the general population matched on age and BMI. As vitamin D levels increased throughout the study, fewer patients fell below the 10
th
percentile. Conclusions: The high-dose vitamin D group maintained wider phase angle values over 24 weeks, while phase angle for the low-dose group decreased from baseline. High-dose vitamin D supplementation may impact factors related to phase angle and frailty in patients receiving ADT. Funding: NCI UGCA189961, R21CA175793, K07CA168911, and GR501293.
