Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy.

BACKGROUND: Our aim was to determine feasibility and effect sizes of bright light therapy (BLT), melatonin (MLT), methylphenidate (MP) and eight combinations (BLT+MLT+MP, BLT+MLT, BLT+MP, BLT alone, MLT+MP, MLT alone, MP alone, placebo for BLT, MLT and MP) defined as multimodal therapy (MMT), to improve sleep quality (SQ) (Pittsburgh Sleep Quality Index (PSQI)) from baseline to day 15. We also examined the effects of MMT on insomnia, fatigue, depression, quality of life and actigraphy. METHODS: Patients with advanced cancer with poor SQ (PSQI ≥5) were eligible. Using a double-blind randomised factorial study design, patients were randomised into 1 of the 8 arms for 2 weeks. Feasibility and effect sizes were assessed. RESULTS: 81% (54/67) of randomised patients completed the study. There were no differences in the demographics and SQ between groups. The adherence rates for BLT, MLT and MP were 93%, 100% and 100%, respectively. BLT+MLT+placebo of MP; BLT+placebo of MLT+placebo of MP; BLT+MLT+MP showed an effect size (Cohen's d) for change in PSQI scores of 0.64, 0.57 and 0.63, respectively. PSQI change using linear regression showed BLT (n=29) has effect size of 0.46, p=0.017; MLT (n=26), 0.24, p=0.20; MP (n=26), 0.06, p=0.46. No significant differences were observed in scores for insomnia, fatigue, depression, quality of life and actigraphy. There were no differences in adverse events by groups(p=0.80). CONCLUSIONS: The use of MMT to treat SQ disturbance was feasible. BLT+MLT showed the most promising effect size in improvement in SQ, and additional larger studies are needed. TRIAL REGISTRATION NUMBER: NCT01628029.

Human Biofield Therapy Modulates Tumor Microenvironment and Cancer Stemness in Mouse Lung Carcinoma.

Studies have demonstrated that purported biofield therapy emitted from humans can inhibit the proliferation of cancer cells and suppress tumor growth in various cancers. We explored the effects of biofield therapy on tumor growth in the Lewis lung carcinoma and expanded mechanistic outcomes. We found biofield therapy did not inhibit tumor growth. However, the experimental (Ex) condition exposed tumors had a significantly higher percentage of necrosis (24.4 ± 6.8%) compared with that of the Control condition (6.5 ± 2.7%; P < .02) and cleaved caspase-3 positive cells were almost 2.3-fold higher (P < .05). Similarly, tumor-infiltrating lymphocytes profiling showed that CD8+/CD45+ immune cell population was significantly increased by 2.7-fold in Ex condition (P < .01) whereas the number of intratumoral FoxP3+/CD4+ (T-reg cells) was 30.4% lower than that of the Control group (P = .01), leading to a significant 3.1-fold increase in the ratio of CD8+/T-reg cells (P < .01). Additionally, there was a 51% lower level of strongly stained CD68+ cells (P < .01), 57.9% lower level of F4/80high/CD206+ (M2 macrophages; P < .02) and a significant 1.8-fold increase of the ratio of M1/M2 macrophages (P < .02). Furthermore, Ex exposure resulted in a 15% reduction of stem cell marker CD44 and a significant 33% reduction of SOX2 compared with that of the Controls (P < .02). The Ex group also engaged in almost 50% less movement throughout the session than the Controls. These findings suggest that exposure to purported biofields from a human is capable of enhancing cancer cell death, in part mediated through modification of the tumor microenvironment and stemness of tumor cells in mouse Lewis lung carcinoma model. Future research should focus on defining the optimal treatment duration, replication with different biofield therapists, and exploring the mechanisms of action.

Characteristics and Outcomes of Advanced Cancer Patients Who Received Palliative Care at a Public Hospital Compared with Those at a Comprehensive Cancer Center.

BACKGROUND: Patients with advanced cancer experience severe physical, psychosocial, and spiritual distress requiring palliative care (PC). There are limited literature regarding characteristics and outcomes of patients evaluated by PC services at public hospitals (PHs). Objective, Design, Setting/Subjects, and Measurements: To compare the outcomes of advanced cancer patients undergoing PC at a PH and those at a comprehensive cancer center (CCC). We reviewed 359 consecutive advanced cancer patients (PH, 180; CCC, 179) undergoing PC. Symptoms and outcomes at consultation and first follow-up visit were assessed. Summary statistics were used to describe patient characteristics and outcomes. RESULTS: The PH and CCC patients differed significantly according to race: 23% white, 39% black, and 36% Hispanic patients at the PH versus 66% white, 17% black, and 11% Hispanic patients at the CCC (p < 0.0001). Ninety-six (53%) patients at PH and 178 (99%) at the CCC had health insurance (p < 0.0001). Symptoms at consultation at PH and CCC were pain (85% and 91%, respectively; p = 0.0639), fatigue (81% and 94%, respectively; p = 0.0003), depression (51% and 69%, respectively; p = 0.0013), anxiety (47% and 75%, respectively; p < 0.0001), and well-being (63% and 93%, respectively; p < 0.0001). Multiple interventions provided: opioids, reviews for polypharmacy, constipation management, and interdisciplinary counseling. Median time from outpatient consultation to follow-up was 29 days(range, 1-119 days) at the PH and 21 days (range, 1-275 days) at the CCC (p = 0.0006). Median overall survival time from outpatient consultation was 473 days (95% confidence interval [CI], 205-699 days) at PH and 245 days (95% CI, 152-491 days) at CCC (p = 0.3408). CONCLUSIONS: Advanced cancer patients at both institutions frequently had multiple distressing physical and emotional symptoms, although the frequency was higher at CCC. The median overall survival duration was higher at the PH. More research is needed.

Financial Distress and Its Associations With Physical and Emotional Symptoms and Quality of Life Among Advanced Cancer Patients.

OBJECTIVE: There are limited data on the effects of financial distress (FD) on overall suffering and quality of life (QOL) of patients with advanced cancer (AdCa). In this cross-sectional study, we examined the frequency of FD and its correlates in AdCa. PATIENTS AND METHODS: We interviewed 149 patients, 77 at a comprehensive cancer center (CCC) and 72 at a general public hospital (GPH). AdCa completed a self-rated FD (subjective experience of distress attributed to financial problems) numeric rating scale (0 = best, 10 = worst) and validated questionnaires assessing symptoms (Edmonton Symptom Assessment System [ESAS]), psychosocial distress (Hospital Anxiety and Depression Scale [HADS]), and QOL (Functional Assessment of Cancer Therapy-General [FACT-G]). RESULTS: The patients' median age was 60 years (95% confidence interval [CI]: 58.6-61.5 years); 74 (50%) were female; 48 of 77 at CCC (62%) versus 13 of 72 at GPH (18%) were white; 21 of 77 (27%) versus 32 of 72 (38%) at CCC and GPH, respectively, were black; and 7 of 77 (9%) versus 27 of 72 (38%) at CCC and GPH, respectively, were Hispanic (p < .0001). FD was present in 65 of 75 at CCC (86%; 95% CI: 76%-93%) versus 65 of 72 at GPH (90%; 95% CI: 81%-96%; p = .45). The median intensity of FD at CCC and GPH was 4 (interquartile range [IQR]: 1-7) versus 8 (IQR: 3-10), respectively (p = .0003). FD was reported as more severe than physical distress, distress about physical functioning, social/family distress, and emotional distress by 45 (30%), 46 (31%), 64 (43%), and 55 (37%) AdCa, respectively (all significantly worse for patients at GPH) (p < .05). AdCa reported that FD was affecting their general well-being (0 = not at all, 10 = very much) with a median score of 5 (IQR: 1-8). FD correlated (Spearman correlation) with FACT-G (r = -0.23, p = .0057); HADS-anxiety (r = .27, p = .0014), ESAS-anxiety (r = .2, p = .0151), and ESAS-depression (r = .18, p = .0336). CONCLUSION: FD was very frequent in both groups, but median intensity was double among GPH patients. More than 30% of AdCa rated FD to be more severe than physical, family, and emotional distress. More research is needed to better characterize FD and its correlates in AdCa and possible interventions. IMPLICATIONS FOR PRACTICE: Financial distress is an important and common factor contributing to the suffering of advanced cancer patients and their caregivers. It should be suspected in patients with persistent, refractory symptom expression. Early identification, measurement, and documentation will allow clinical teams to develop interventions to improve financial distress and its impact on quality of life of advanced cancer patients.