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Pain and insomnia often co-occur and impair the quality of life in cancer survivors. This study evaluated the effect of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on pain severity among cancer survivors with comorbid pain and insomnia. Using data from the CHOICE trial that compared acupuncture versus CBT-I for insomnia among cancer survivors, we analyzed the effect of interventions on pain outcomes in 70 patients with moderate to severe baseline pain. Interventions were delivered over eight weeks. We assessed average pain severity (primary outcome) and pain interference at baseline, week 8, and week 20. We further defined insomnia and pain responders as patients who achieved clinically meaningful improvement in insomnia and pain outcomes, respectively, at week 8. We found that compared with baseline, the between-group difference (-1.0, 95% CI -1.8 to -0.2) was statistically significant favoring acupuncture for reduced pain severity at week 8 (-1.4, 95% CI -2.0 to -0.8) relative to CBT-I (-0.4, 95% CI-1.0 to 0.2). Responder analysis showed that 1) with acupuncture, insomnia responders reported significantly greater pain reduction from baseline to week 4, compared with insomnia non-responders (-1.5, 95% CI -2.7 to -0.3); 2) with CBT-I, pain responders reported significantly greater insomnia reduction at week 8, compared with pain non-responders (-4.7, 95% CI -8.7 to -1.0). These findings suggest that among cancer survivors with comorbid pain and insomnia, acupuncture led to rapid pain reductions, which contributed to a decrease in insomnia, whereas CBT-I had a delayed effect on pain, possibly achieved by insomnia improvement.

Background Engagement in physical activity (PA) post-treatment can improve health outcomes and quality of life among cancer survivors. The purpose of this study is to explore United States (US) older adult cancer survivors’ (OACS) reasons for engaging in group-based PA classes, to identify themes supporting exercise motivations in the context of cancer recovery. Methods OACS participating in a fitness program at a large US comprehensive cancer center completed semi-structured interviews. Transcripts were analyzed using modified grounded theory, and demographic data were analyzed descriptively. Results Modified grounded theory analysis (n = 25; age M = 70.92, SD = 10.82; 9 cancer types) identified individual rationales for exercise grounded in collective experience. Participants’ internal motivations for PA are shaped by the desire for control over an uncertain future and post-treatment body, obtained by literally “moving forward” post-cancer; this is supported by external motivations for social connections that present a positive model of survivorship, within a setting that instills confidence and safety. Conclusions Exercise can be a way for older adults to tap into internal and external motivations that support cancer survivorship. Interventions that make explicit connections between exercise and cancer recovery, facilitate interpersonal interaction, and promote a sense of safety may be the most effective. The concepts identified in this study can inform the development of future interventions to improve long-term behavior change among OACS and evaluate existing PA programs.

PURPOSE: Cancer-related fatigue is a prevalent, debilitating symptom that contributes to increased health care utilization among hospitalized patients. Music therapy is a nonpharmacological intervention that uses active (eg, singing, selecting songs) and passive (eg, listening) techniques. Preliminary evidence from small trials suggests a potential benefit for cancer-related fatigue in the inpatient setting; however, it remains unclear which techniques are most effective. METHODS: A cross-sectional mixed-methods study was performed to compare cancer-related fatigue before and after active or passive music therapy. Cancer-related fatigue was captured via the Edmonton Symptom Assessment Scale fatigue item. Patients were asked to provide postsession free-text comments. RESULTS: A total of 436 patients (mean [standard deviation] age, 62.2 [13.4] years; n = 284 [65.1%] women; n = 294 [67.4%] white; active music therapy n = 360 [82.6%]; passive music therapy n = 76 [17.4%]) with a range of primary malignancies participated. Active music therapy was associated with a 0.88-point greater reduction in cancer-related fatigue (95% CI, 0.26 to 1.51; P = .006; Cohen’s D, 0.52) at postsession as compared with passive music therapy when restricting the analysis to patients who rated their baseline cancer-related fatigue as moderate to severe (ie, ≥ 4; n = 236 [54.1%]). Free-text responses confirmed higher frequencies of words describing positive affect/emotion among active music therapy participants. CONCLUSIONS: In a large sample of inpatient adults with diverse cancer disease types, active music therapy was associated with greater reduction in cancer-related fatigue and increased reporting of positive affect/emotions compared with passive music therapy. Additional research is warranted to determine the specific efficacy and underlying mechanisms of music therapy on cancer-related fatigue.

Background Arthralgia is a common and debilitating toxicity of aromatase inhibitors (AI) that leads to premature drug discontinuation. We sought to evaluate the clinical and genetic risk factors associated with AI-associated arthralgia (AIAA). Methods We performed a cross-sectional study among postmenopausal women with stage 0-III breast cancer who were prescribed a third-generation AI for adjuvant therapy. The primary outcome was patient-reported AIAA occurrence. We extracted and assayed germline DNA for single nucleotide polymorphisms (SNPs) of genes implicated in estrogen and inflammation pathways. Multivariable logistic regression models examined the association between demographic, clinical, and genetic factors and AIAA. Analyses were restricted to White participants. Results Among 1049 White participants, 543 (52%) reported AIAA. In multivariable analyses, women who had a college education [Adjusted Odds Ratio (AOR) 1.49, 95% Confidence Interval (CI) 1.00–2.20], had a more recent transition into menopause (, Highlights • One in two postmenopausal women experience aromatase inhibitor-associated arthralgia. • Shorter time since starting menopause and aromatase inhibitors are clinical risk factors for AIAA. • SNP rs11648233 (HSD17B2) in the estrogen pathway may contribute to AIAA.

CONTEXT. Depressive symptoms are prevalent and associated with greater healthcare utilization among hospitalized adults with cancer. Music therapy and massage therapy are available at many National Cancer Institute (NCI)-Designated Cancer Centers and recommended by the American Society of Clinical Oncology for depressive symptoms, but a paucity of studies have compared these two therapies. OBJECTIVES. We conducted a retrospective, multi-method program evaluation of single, first-time music therapy and massage therapy sessions delivered to hospitalized adults with cancer. METHODS. The study was conducted at an NCI-Designated Comprehensive Cancer Center between February 2018 and October 2019. We assessed depressive symptoms with the Edmonton Symptom Assessment Scale (ESAS) depression item. We also invited patients to provide free-text comments describing their treatment experience. RESULTS. Among 1764 patients (61.2% women, 72.7% white), 350 received music therapy and 1414 received massage therapy; music therapy was associated with a 0.4 point greater reduction (95% 0.3 to 0.6, P < 0.001) in the ESAS depression score relative to massage therapy. When analyses were restricted to the 452 (25.6%) patients with moderate-to-severe depressive symptoms (ESAS score ≥ 4), music therapy was associated with a 1.2 point greater reduction (95% CI 0.7 to 1.7, P < 0.001) relative to massage therapy, a clinically meaningful difference. In free-text comments, music therapy was described as energizing, uplifting, and evocative, whereas massage therapy was described as calming and relaxing. CONCLUSION. Among hospitalized adult cancer patients, both music therapy and massage therapy were associated with reduced depressive symptoms, but music therapy was associated with a greater reduction than massage therapy. J Pain Symptom Manage 2021;000:1−5.

INTRODUCTION: The authors compared the availability of integrative medicine therapies in National Cancer Institute-Designated Comprehensive Cancer Centers and community hospitals. METHODS: The authors reviewed 51 Comprehensive Cancer Center and 100 community hospital websites and collected race and median household income data for community hospital populations. RESULTS: Availability of acupuncture (56% vs. 76.5%, p = 0.01), meditation (63% vs. 82.4%, p = 0.02), and music therapy (55% vs. 74.5%, p = 0.02) was significantly lower at community hospitals compared with Comprehensive Cancer Centers. Integrative medicine availability was also significantly lower in community hospitals serving lower-income populations. CONCLUSION: Equitable access to evidence-based integrative medicine in community hospitals is needed.

Context Patients with gastric cancer experience health-related quality of life (HRQOL) decline during adjuvant chemotherapy following gastrectomy. Objectives This pilot study aimed to evaluate the preliminary effect and feasibility of electro-acupuncture (EA) for HRQOL and symptom burden in these patients. Methods In this open-label, multicenter, parallel controlled trial, gastric cancer patients who planned to receive adjuvant chemotherapy were randomly assigned to receive high-dose EA (seven times each chemotherapy cycle for three cycles), low-dose EA (three times each chemotherapy cycle), or usual care only. The acupoints prescription consisted of bilateral ST36, PC6, SP4, and DU20, EX-HN3, and selected Back-shu points. Patients completed the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) weekly, and the Edmonton Symptom Assessment System (ESAS). The primary outcome was the difference among the groups on the gastric cancer subscale (GaCS) of the FACT-Ga. Results Of the 66 randomized patients, 58 were analyzed according to intention-to-treat principle, and 45 were in the per-protocol set (PPS). The average scores in PPS of GaCS were 52.12±9.71, 51.85±12.36, and 45.37±8.61 in high-dose EA, low-dose EA, and control groups, respectively. EA was significantly associated with improved average GaCS scores when compared with control group (51.98±10.91 vs. 45.37±8.61, P = 0.039). EA treatment also produced ESAS relief at the end of intervention (14.36 ± 12.28 vs. 23.91 ± 15.52, P = 0.027). Participants in EA groups had fewer grade ≥3 leukopenia (0% vs. 15.79%, P = 0.031) and neutropenia (2.56% vs. 26.31%, P = 0.012). Conclusion EA showed promising effects in improving HRQOL, controlling symptom burden, and reducing toxicity during adjuvant chemotherapy in gastric cancer patients. Future adequately powered trials are feasible and needed to confirm the specific effect of EA.

Introduction: Spleen Deficiency Syndrome (SDS) is recognized as one of the most common Traditional Chinse Medicine (TCM) syndromes in patients with colorectal cancer (CRC). However so far there is no existing patient-reported outcome (PRO) to evaluate SDS. Our study aimed to develop and validate a PRO TCM-SDS scale for CRC in China. Methods: We developed an initial 8-item TCM-SDS scale for CRC based on literature review and consultation with experts. We then pilot tested the scale ( n = 40) and performed item revision. We conducted a survey study among CRC patients from oncology clinics at a TCM Hospital to further determine the reliability and validity of the scale. Results: Among 100 patients finally enrolled and analyzed in the survey study, 46% were female with median age of 60 years old, 77% had left side tumors and 23% had stage IV disease. Factor loading indicated that there were three domains within TCM-SDS scale. The final TCM-SDS scale involves 5 items including “I feel loss of appetite,” “I feel abdomen fullness,” “I feel my arms and legs lack strength,” “I feel short of breath when talking,” and “My stool is formless” (Cronbach’s alpha coefficient 0.76). We calculated the total score of the scale by summing the 5 individual items and normalizing them to a value maximum of 10, with higher scores indicating greater burden of spleen deficiency syndrome. The average spleen deficiency score for all patients was 3.55 ± 1.54. Among them, those who had stage IV disease had higher scores than stage I-III patients (4.30 vs 3.38, P = .015). Test-retest reliability after 2 weeks showed Pearson coefficient of 0.67 and all items were highly related ( P Conclusion: The patient-reported TCM-SDS scale for CRC showed adequate initial reliability and validity. The development of the scale provided an outcome measurement tool, which could facilitate future studies to better evaluate the role of TCM in treating CRC.

PURPOSE: CIPN is a common, debilitating, and dose-limiting side effect of chemotherapy. Here, we describe characteristics of patients with CIPN using both patient-reported outcomes (PRO) and quantitative sensory testing (QST). METHODS: Breast cancer survivors with persistent moderate to severe CIPN defined by a rating of 4 or greater on a 0–10 Numeric Rating Scale (NRS) from two ongoing clinical trials were included. PROs included the Neuropathic Pain Scale (NPS) and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity (FACT/GOG-Ntx). QST included tactile and vibration detection threshold measurements. Data were analyzed using descriptive statistics and Spearman correlation coefficients. RESULTS: 49 female patients with a mean age of 61 years were assessed; 63% were Caucasian. Mean NRS scores were 4.2, 5.7, and 4.3 on 0–10 scale for pain, numbness, and tingling, respectively. Mean NPS score was 41.0 on a 0–100 scale, and the mean FACT/GOG-Ntx score was 25.8 on a 0–44 scale. QST showed mild to moderate impairments in tactile and vibration perception. The FACT/GOG-Ntx subscale for numbness was negatively correlated with tactile and vibration thresholds in both hands and feet (both p < 0.05). NPS was positively correlated with tactile thresholds in the hands and feet (p < 0.05). CONCLUSION: Patients with moderate to severe CIPN report moderate pain, numbness, and tingling, and exhibit reduced tactile and vibration perception on QST. Weak to moderate correlations were observed between PRO and QST. These data suggest that QST outcomes are associated with CIPN symptoms and may be useful in helping monitor and manage CIPN treatment.

Objective In response to the national opioid crisis, governmental and medical organizations have called for broader insurance coverage of acupuncture to improve access to nonpharmacologic pain therapies, especially in cancer populations, where undertreatment of pain is prevalent. We evaluated whether cancer patients would be willing to use insurance-covered acupuncture for pain. Design and Setting We conducted a cross-sectional survey of cancer patients with pain at one academic center and 11 community hospitals. Methods We used logistic regression models to examine factors associated with willingness to use insurance-covered acupuncture for pain. Results Among 634 cancer patients, 304 (47.9%) reported willingness to use insurance-covered acupuncture for pain. In univariate analyses, patients were more likely to report willingness if they had severe pain (odds ratio [OR] = 1.59, 95% confidence interval [CI] = 1.03–2.45) but were less likely if they were nonwhite (OR = 0.59, 95% CI = 0.39–0.90) or had only received high school education or less (OR = 0.46, 95% CI = 0.32–0.65). After adjusting for attitudes and beliefs in multivariable analyses, willingness was no longer significantly associated with education (adjusted OR [aOR] = 0.78, 95% CI = 0.50–1.21) and was more negatively associated with nonwhite race (aOR = 0.49, 95% CI = 0.29–0.84). Conclusions Approximately one in two cancer patients was willing to use insurance-covered acupuncture for pain. Willingness was influenced by patients’ attitudes and beliefs, which are potentially modifiable through counseling and education. Further research on racial disparities is needed to close the gap in utilization as acupuncture is integrated into insurance plans in response to the opioid crisis.

OBJECTIVE: One of the most prevalent and distressing symptoms following breast cancer treatment is menopausal symptoms. Asian American breast cancer survivors have lower quality of life and often receive inadequate management of menopausal symptoms compared to other racial/ethnic groups. Technology-based programs could be a solution to fill the gap in care. The purpose of this study was to test the efficacy of a technology-based information and coaching/support program on menopausal symptoms of Asian American breast cancer survivors. METHODS: This study adopted a randomized pretest/posttest group design among 91 Asian American breast cancer survivors (42 in an intervention group who used the program and the American Cancer Society [ACS] website and 49 in a control group who used only the ACS website). The intervention was a theory-driven and culturally tailored intervention program that aimed to provide information and coaching/support using computers and mobile devices. Multiple instruments were used to measure background characteristics and menopausal symptoms at pre-test, post 1-month, and post 3-months. An intent-to-treat linear mixed-model growth curve analysis was used to analyze the data. RESULTS: The intervention group showed a significant decrease in the distress scores of menopausal symptoms over time: physical (β = −0.07, p = 0.08), psychological (β = −0.13, p = 0.05), psychosomatic (β = −0.17, p = 0.06), and total symptoms (β = −0.19, p = 0.01). Theory-based variables including attitudes, social influences and self-efficacy partially mediated the impact of the intervention on the distress scores of menopausal symptoms (p < 0.10). CONCLUSIONS: The program was effective in alleviating menopausal symptoms of Asian American breast cancer survivors.

Erdheim-Chester disease (ECD) is an ultra-rare hematologic neoplasm characterized by somatic mutations of the MAPK pathway and by accumulation of lesional histiocytes within tissues. Clinical phenotypes and sites of disease involvement are heterogenous in ECD, and no tool exists for systematic and comprehensive assessment of ECD symptomatology. We describe a collaborative effort among ECD specialists, patient-reported outcome (PRO) methodologists, and ECD patients to develop the Erdheim-Chester Disease Symptom Scale (ECD-SS): a symptom inventory for clinical ECD care and evaluation of ECD therapies. Methodologically rigorous focus groups led to the identification of 63 ECD symptoms in 6 categories, incorporated into the ECD-SS with respect to both severity and frequency. Among 50 ECD patients participating in a prospective registry study completing the ECD-SS, 46 (92%) reported neurological/psychological symptoms, 29 (58%) reported pain, and at least one-half reported mood symptoms, memory problems, or fatigue. Symptoms were highly frequent or almost constant regardless of their severity. The ECD-SS is a rigorously developed, patient-centered tool that demonstrates the wide and previously unappreciated burden of symptomatology experienced by ECD patients. Further studies will refine the symptom inventory and define its psychometric properties and role in clinical care and investigation in the context of ECD.

Background: CIPN is a common, painful, and debilitating side effect of many standard chemotherapy regimens. Patients with CIPN typically experience paresthesia (tingling, numbness), pain, and muscle weakness, and may exhibit significant functional decline and diminished quality of life. Our prior study showed that more than half of breast cancer survivors experience persistent CIPN up to a mean duration of 5.6 years and that this symptom is associated with a doubled fall risk. There is an urgent need to identify nonpharmacological approaches to reduce CIPN symptoms and improve cancer survivors' functional outcomes. Yoga is a mind-body modality that includes stretching, flexibility, and balance training; however, little is known about its effects on symptoms and functional outcomes among cancer survivors with CIPN. Trial Design: We are conducting a two-arm pilot randomized usual care controlled trial in breast and gynecological cancer survivors at Memorial Sloan Kettering Cancer Center (MSK), New York, NY. Eligible subjects in the intervention arm receive one-hour Hatha Yoga classes taught twice weekly for eight weeks, and practice home-based yoga for a total of 12 weeks. Subjects in the wait list control (WLC) arm continue usual care for 12 weeks, followed by eight weeks of yoga classes and home-based yoga. Eligibility Criteria: 1) Patients with a primary diagnosis of stage I-III breast, ovarian, uterine, or endometrial cancer; 2) moderate to severe CIPN, defined by four or greater on a 0–10 Numeric Rating Scale (NRS); 3) completion of neurotoxic chemotherapy at least three months prior; 4) no changes in anti-neuropathy medications within three months of enrollment; and 5) an ECOG performance status of 0–2. Specific Aims: The primary endpoint is safety, feasibility, and NRS changes at eight weeks (end of treatment). The secondary endpoints include the Neuropathic Pain Scale (NPS) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) at eight, 12, and 20 weeks. Statistical Methods: We will accrue 40 patients to get 36 patients evaluable for the primary endpoint at eight weeks. Using an ANCOVA analysis with a sample size of 36, we will be able to detect an effect size of 00.58 standard deviations (SD) of NRS (moderate effect size) between yoga and WLC assuming a NRS correlation between pre- and post-yoga of 0.5 SD. If we assume a 10% dropout rate based on our recently completed trial, we will need to recruit 20 subjects per arm (total of 40) to fall within the precision noted in the sample size calculation. We recognize that the sample size calculation was based on detecting a moderate effect between yoga and WLC and may miss small but clinically meaningful effects that can be used to design a future trial that is sufficiently powered. Present accrual and target accrual: 40 participants. We have accrued 25 participants as of June 2018 and anticipate accrual completion by October 2018. Citation Format: Zhi WI, Leeolou MC, Piulson L, Chen P, Patterson C, Paul T, Patil S, Mao JJ, Bao T. A pilot randomized usual care controlled study of yoga for persistent chemotherapy-induced peripheral neuropathy (CIPN) in breast and gynecological cancer survivors [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-08-01.

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, potentially debilitating, and dose-limiting side effect experienced by breast cancer survivors. CIPN encompasses symptoms such as pain, numbness, and tingling, which can be measured subjectively by patient-reported outcomes (PRO), or objectively by quantitative sensory testing (QST); however, little is known how QST correlates with symptom profiles measured by PRO. Methods: We conducted a cross-sectional analysis using baseline data of two ongoing clinical trials of breast cancer survivors who experienced moderate to severe CIPN defined by pain, numbness, or tingling ratings of four or greater on a numeric rating scale (NRS) after chemotherapy completion for at least three months. PRO measures of CIPN symptoms included Neuropathic Pain Scale (NPS) and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity subscale (FACT/GOG-Ntx). QST included tactile threshold (TT) measured by Von Frey's filaments, and vibration threshold (VT) measured by biothesiometer. We ran a Spearman correlation to assess the relationship between the subjective measures (NPS and FACT/GOG-Ntx) and objective measures (TT and VT QST). Results: We included 52 sets of baseline data on 50 unique patients; two patients were enrolled in both trials at different times. Mean age was 61 years (SD 10) and 66% were white. The mean NRS pain score was 3.9 (SD 2.8), numbness 5.7 (SD 2.2), and tingling 4.3 (SD 2.8) on a 0-10 scale. The mean NPS total score was 39.2 (SD 23.1) on a 0-100 scale, and FACT/GOG-Ntx was 26.2 (SD 6.8) on a 0-44 scale. High scores on NRS and NPS and low scores on FACT/GOG-Ntx signify more severe CIPN symptoms. See Table 1 for a summary of the correlation between two questions on FACT/GOG-Ntx on tingling/numbness in hands and feet, and NPS total score with QST. A moderate correlation was observed between FACT/GOG-Ntx and QST results, suggesting patient-reported hand and foot numbness or tingling is associated with decreased hand and foot tactile and vibration perception. NPS was positively correlated with tactile perception for the hand and foot, but not with vibration perception. Table 1.Correlation between objective and subjective measures of CIPN Tactile QSTVibration QST HandFeetHandFeetFACT/GOG-Ntx-0.33 (P=0.018)-0.28 (P=0.045)-0.37 (P=0.008)-0.40 (P=0.0034)NPS0.34 (P=0.015)0.32 (P=0.022)0.22 (P=0.12)0.03 (P=0.81) Conclusions: A mild to moderate correlation was observed between subjective and objective measurements of CIPN. As CIPN presents a diverse range of symptoms, better quantifying the subjective and objective measures of CIPN can help incorporate these tools in observational and intervention trials. Understanding the correlation between PRO and QST can help establish QST as a reliable objective measurement of CIPN symptoms, and enable targeted interventions to alleviate CIPN symptoms. Citation Format: Bao T, Kwon A, Piulson L, Chen P, Li Q, Patil S, Seidman A, Blinder V, Vahdat L, Zhi WI, Mao JJ. Chemotherapy-induced peripheral neuropathy in breast cancer survivors: Comparison of objective and subjective measures [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-15.

Introduction: Decreased brain-derived neurotrophic factor (BDNF) is associated with poor sleep. This study examined the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on serum BDNF and sleep outcomes in cancer survivors with insomnia. Methods: This was an exploratory analysis of a randomized clinical trial (n = 160) comparing acupuncture versus CBT-I for cancer survivors with insomnia. Interventions were delivered over 8 weeks. Outcomes were assessed at baseline and week 8. Serum BDNF was evaluated with enzyme-linked immunosorbent assay (ELISA). Sleep was evaluated with the insomnia severity index and consensus sleep diary. Pearson correlations between BDNF and sleep outcomes were calculated. Data analysis was limited to 87 survivors who provided serum samples. Results: Among 87 survivors, the mean age was 61.9 (SD: 11.4) years, 51.7% were women, and 24.1% were non-White. Mean serum BDNF did not significantly increase in acupuncture (n = 50) or CBT-I (n = 37) groups. When analysis was restricted to patients with low baseline BDNF (i.e. levels below the sample median of 47.1 ng/mL), the acupuncture group (n = 22) demonstrated a significant 7.2 ng/mL increase in mean serum BDNF (P = 0.03), whereas the CBT-I group (n = 21) demonstrated a non-significant 2.9 ng/mL increase (P = 0.28). Serum BDNF was not significantly correlated with sleep outcomes (all P > 0.05). Conclusion: Among cancer survivors with insomnia and low baseline BDNF, acupuncture significantly increased serum BDNF levels; however, the clinical significance of this finding requires further investigation. Trial registration no. NCT02356575 (ClinicalTrials.gov)

Context Insomnia is a common problem affecting cancer survivors. While effective nonpharmacological treatments are available, it is unknown whether individual genetic characteristics influence treatment response. Objectives We conducted an exploratory analysis of genetic associations with insomnia treatment response in a randomized trial of cognitive behavioral therapy for insomnia (CBT-I) vs. acupuncture in a heterogeneous group of cancer survivors. Methods We successfully genotyped 136 participants for 11 genetic variants. Successful treatment response was defined as a reduction in Insomnia Severity Index score of at least eight points from baseline to week 8. We used Fisher exact tests to evaluate associations between genotype and treatment success for each treatment arm, for an alpha level of 0.05 with unadjusted and Holm-Bonferroni-adjusted P-values. Results We found that more carriers of COMT rs4680-A alleles responded to acupuncture compared to the GG carriers (63.6% vs. 27.8%, P = 0.013). More carriers of the NFKB2 rs1056890 CC genotype also responded to acupuncture compared to TT or CT carriers (72.2% vs. 38.9%, P = 0.009). There were no significant differences found between any of the tested gene variants and CBT-I response. None of the results remained statistically significant after adjustment for multiple testing. Conclusion In cancer survivors, specific variants in the COMT and NFKB2 genes are potentially associated with response to acupuncture but not to CBT-I. Confirming these preliminary results will help inform precision insomnia management for cancer survivors.

Objective Herbs and natural products are increasingly used by cancer patients for pain management, but few studies have examined their integration within conventional cancer care. This study describes the characteristics, experiences, and perspectives of cancer patients who were prescribed an herbal topical analgesic for pain management. Design and Setting Program evaluation of a pilot herbal dispensary at a National Cancer Institute–designated comprehensive cancer center. Subjects Cancer patients who were prescribed the Tibetree Pain-Relieving Plaster (PRP) by an integrative medicine physician. Methods Sociodemographic and clinical characteristics of patients were abstracted from medical records. Semistructured phone interviews were conducted 1–2 weeks after PRP prescription to evaluate patient experiences with using PRP for pain. Interviews were analyzed through thematic content analysis. Results From February 2019 to February 2020, 50 patients were prescribed PRP. Median age (range) was 63 years (21–86), 37 patients (74%) were female, 14 (28%) were non-White, and 38 (76%) were using oral analgesics. During interviews, the majority of patients reported that the PRP improved pain and health-related outcomes, was convenient to use, and addressed pain management needs that were not fulfilled by oral analgesics. However, a few patients described adverse experiences with PRP, including skin irritation. Conclusions Understanding patient experiences and perspectives is a critical step toward evidence-based integration of herbs and natural products into cancer pain management. Findings from this program evaluation will inform the design of a randomized clinical trial on the efficacy and safety of PRP for pain in patients with cancer.

BACKGROUND: Cancer survivors are prone to insomnia due to the physical and psychological sequelae of cancer and treatment. Individuals with insomnia may present symptoms of hyperarousal. Cancer survivors with insomnia and trait hyperarousal may require different clinical treatments than patients with insomnia without trait hyperarousal. To our knowledge, no study has examined these factors previously. This study examined the relation between insomnia and trait hyperarousal in cancer survivors. METHODS: The sample included 160 individuals with previous cancer diagnoses who met DSM-5 criteria for Insomnia Disorder. Measures were collected with cross-sectional batteries of questionnaires, including the Insomnia Severity Index (ISI) and Hyperarousal Scale (HAS). This study is based on baseline data collected in a randomized clinical trial comparing CBT-I to acupuncture for cancer survivors with insomnia (Garland, Gehrman, Barg, Xie, & Mao, 2016). RESULTS: Hyperarousal was positively associated with insomnia (ISI total score) in bivariate correlations (r = .350, p < .01) and linear regressions (F = 22.06, p < .001). In bivariate correlations, hyperarousal was related to perceptions about the consequences of disturbed sleep rather than reported sleep patterns. For example, hyperarousal was positively related to reported satisfaction (r = .159, p < .05) and worry about sleep (r = .415, p < .01), but not to falling asleep, staying asleep, or awakening too early. In regressions, younger age, insomnia duration, and worry about sleep were uniquely associated with hyperarousal when adjusting for insomnia (B = 0.200, B = 0.177, B = −0.182, p < .05). CONCLUSIONS: Hyperarousal is associated with psychological appraisal of insomnia rather than reported sleep pattern. Younger age and longer duration of insomnia are associated with trait hyperarousal. These findings suggest targeting trait hyperarousal with amplified psychological treatment may lead to more personalized, effective treatment for insomnia.

ObjectiveInsomnia is a common, distressing, and impairing psychological outcome experienced by informal caregivers (ICs) of patients with cancer. Cognitive behavioral therapy for insomnia (CBT-I) and acupuncture both have known benefits for patients with cancer, but such benefits have yet to be evaluated among ICs. The purpose of the present study was to evaluate the feasibility, acceptability and preliminary effects of CBT-I and acupuncture among ICs with moderate or greater levels of insomnia.MethodParticipants were randomized to eight sessions of CBT-I or ten sessions of acupuncture.ResultsResults highlighted challenges of identifying interested and eligible ICs and the impact of perception of intervention on retention and likely ultimately outcome.Significance of the resultsFindings suggest preliminary support for non-pharmacological interventions to treat insomnia in ICs and emphasize the importance of matching treatment modality to the preferences and needs of ICs.

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect in cancer survivors. This study aimed to assess the characteristics of quantitative sensory testing (QST) and its correlation with patient-reported outcomes (PROs) in cancer patients with and without CIPN. METHODS: We conducted a cross-sectional analysis using baseline data from two clinical trials in solid tumor cancer survivors with no CIPN symptoms rated

Background There is growing interest in using herbal supplements to treat constipation; however, little evidence exists for their use. Purpose This study evaluates the efficacy and safety of herbal formula MaZiRenWan (Hemp Seed Pill, HSP) in patients with functional or non-functional constipation. Study Design Systematic review and meta-analysis Methods PubMed, CENTRAL, Embase, CNKI, and Wanfang were searched through April 20, 2020 for randomized trials of HSP versus placebo or medications for all types of constipation. The primary outcomes were complete response rate, complete spontaneous bowel movement (CSBM), patient-reported satisfactory treatment rate (prSTR), and adverse events (AEs). Clinical data were analyzed using a random-effects model, and the quality of evidence was evaluated with the GRADE system. Results This review includes 1681 constipation patients from 17 moderate-to-high risk of bias trials that were conducted in east Asia. Two high-quality trials showed that HSP compared with placebo significantly increased weekly CSBM (mean difference, 0.95; 95% CI: 0.56, 1.35) and had a higher complete response rate (risk ratio [RR], 1.43; 95% CI: 1.20, 1.71) in patients with functional constipation. Low-quality evidence showed significant improvement in prSTR in HSP compared with conventional medications (RR, 1.79; 95% CI: 1.42, 2.25). Additionally, HSP use did not increase AEs compared with no HSP (p = 0.99). Conclusions This study found that HSP was effective among Asian patients with functional constipation. Rigorous trials need to be conducted in clinical populations outside of east Asia and in those with non-functional constipation to increase the generalizability of the evidence.

Background: Musculoskeletal pain is a common and debilitating condition for cancer patients. Existing therapies for these pain conditions have substantial limitations. To identify an integrative approach to pain management, we conducted a systematic review to evaluate the safety and efficacy of a Tibetan herbal-based topical agent, CheeZheng Pain Relieving Plaster (PRP), for the treatment of osteoarthritis (OA) pain. Methods: We extracted citations from PubMed and Chinese databases (CNKI, WanFang Data, and CQVIP). We included randomized clinical trials evaluating the effectiveness and safety of CheeZheng PRP compared to conventional OA pain treatments. Results: Twenty-two randomized clinical trials (n = 2556 participants) compared CheeZheng PRP against nonsteroidal anti-inflammatory drugs (11), glucosamine (2), intraarticular corticosteroid (2), hyaluronic acid injections (6), and acetaminophen (1). Ten studies found a statistically greater effectiveness (assessed by ≥30% reduction in symptom severity) of CheeZheng PRP in improving OA pain (measured by the Visual Analogue Scale), stiffness, and function compared to control. Ten studies reported that 4.8% of participants experienced application site skin irritation that resolved after discontinuing the plaster. Randomization was not sufficiently described in most studies, and no placebo-controlled trials were identified. Conclusions: There is promising evidence for the safety and clinical effectiveness of CheeZheng PRP to treat OA; however, lack of placebo control and unclear descriptions of randomization increase the potential risk for bias. Future randomized, placebo-controlled trials are needed to establish the safety and efficacy of CheeZheng PRP for pain management in oncology settings.

Objectives: This exploratory analysis examined the putative antidepressant effect of Matricaria chamomilla L. (chamomile) extract in subjects with generalized anxiety disorder (GAD) with or without comorbid depression. It was hypothesized that chamomile extract would demonstrate similar anxiolytic activity in both subgroups, but superior antidepressant activity in GAD subjects with comorbid depression. Design: As part of a randomized double-blind placebo-controlled trial of chamomile extract for relapse prevention of GAD, 179 subjects received initial therapy with open-label chamomile extract 1500 mg daily for 8 weeks. Linear mixed-effect models were used to identify clinically meaningful changes in anxiety and depression symptoms between diagnostic subgroups. Settings/Location: The study took place at the University of Pennsylvania in Philadelphia, PA. Subjects: Subjects were ≥18 years old with a primary DSM IV-TR diagnosis of GAD. They were subcategorized into two diagnostic groups: GAD without comorbid depression (n = 100) and GAD with comorbid depression (n = 79). Interventions: Open-label chamomile extract 1500 mg was given daily for 8 weeks. Outcome measures: Generalized anxiety disorder (GAD-7), Hamilton rating scale for anxiety, Beck anxiety inventory, Hamilton rating scale for depression (HRSD), the six-item core HRSD (items 1, 2, 3, 7, 8, and 13), and the Beck depression inventory (BDI). Results: The authors observed similar anxiolytic effects over time in both diagnostic subgroups. However, there was a greater reduction in HRSD core symptom scores (p

PURPOSE: To define the prevalence and risk factors of anxiety and examine rates and predictors of psychotherapy and integrative medicine service use in breast cancer survivors on AIs. METHODS: Observational study of patients with histologically confirmed stage 0 to III hormone receptor-positive breast cancer taking a third generation AI at the time of enrollment. Patients completed self-report measures of anxiety and utilization of psychotherapy and integrative medicine services at a single time-point. We used multivariate logistic regression analyses to identify factors associated with anxiety and receipt of anxiety treatment services. RESULTS: Among the 1,085 participants, the majority were younger than 65 years of age (n=673, 62.0%) and white (n=899, 82.9%). Approximately one-third (30.8%) reported elevated anxiety (≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale). Of patients with elevated anxiety, only 24.6% reported receiving psychological counseling, 25.3% used integrative medicine services, and 39.8% received either type of treatment since their diagnosis. Patients with an education level of high school or less were less likely to receive psychological counseling (AOR, .43, 95% CI .19–.95) and integrative medicine services (OR, .30, 95% CI .12–.72) than patients with higher levels of education. CONCLUSIONS: Anxiety is common in breast cancer patients treated with AIs yet the majority of anxious patients do not receive evidence-based treatment, even when these treatments are available. Better systematic anxiety screening and treatment initiation are needed to reduce disparities in care by education level.

Background: Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non–small cell lung cancer (NSCLC) undergoing chemotherapy. Methods: We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 ratio) to receive oral RPF (3.36 g/day) or placebo daily for 6 weeks. The main outcome was the Functional Assessment of Cancer Therapy–Lung (FACT-L). We evaluated RPF’s safety profile using the Common Terminology Criteria for Adverse Events and assessed changes in outcome measures from baseline to weeks 3 and 6 using a linear mixed effects model. Results: We enrolled 82 participants across 8 cancer centers in China. The median age was 59 years, 56 (68%) had advanced cancer. Compared with the placebo group, the RPF group had nonstatistically significant higher quality of life as measured by the FACT-L total score ( P = .086) over 2 cycles of chemotherapy. The RPF group was associated with a nonsignificant better general health ( P = .050) and emotional well-being ( P = .090) than the placebo group. Adverse events rates did not differ between groups. Conclusions: This study demonstrated preliminary safety and suggests a promising trend in RPF’s effect on maintaining quality of life and emotional well-being among NSCLC patients undergoing chemotherapy. Future adequately powered randomized-controlled trials are needed to verify the efficacy and safety of RPF in cancer patients undergoing chemotherapy.

Cyclophosphamide is associated with chemotherapy-related ovarian failure (CROF) in breast cancer survivors, however little is known about predicting individual risks. We sought to identify genetic alleles as biomarkers for risk of CROF after cyclophosphamide treatment. 115 premenopausal women with newly diagnosed breast cancer were genotyped for single nucleotide polymorphisms (SNPs) in genes involved in cyclophosphamide activation (CYP3A4 and CYP2C19) and detoxification (GSTP1 and GSTA1). Patients prospectively completed menstrual diaries. With median follow up of 808 days, 28% experienced CROF. Survivors homozygous for the GSTA1 minor allele had lower hazards for developing CROF (HR 0.22 [95% CI 0.05–0.94], p=0.04), while survivors homozygous for the CYP2C19 minor allele had higher hazards for developing CROF (HR 4.5 [95% CI 1.5–13.4], p=0.007) compared to patients with at least one major allele. In separate multivariable models adjusting for age and tamoxifen use, the associations were attenuated (GSTA1 HR 0.24 [95% CI 0.06–1.0], p=0.05; CYP2C19 HR 2.5 [0.8–7.6], p=0.11). CYP3A4 and GSTP1 SNPs were not significantly related to CROF. In younger breast cancer survivors undergoing cyclophosphamide-based chemotherapy, genetic variation in CYP2C19 and GSTA1 may be associated CROF.

BACKGROUND Cancer-related cognitive impairment is a prevalent, disruptive condition potentially exacerbated by sleep disturbances. The current study was performed to evaluate the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on objective and subjective cognitive function in cancer survivors with insomnia. METHODS Using data from a randomized clinical trial (160 survivors) that compared acupuncture versus CBT-I for insomnia occurring in cancer survivors, the authors analyzed cognitive outcomes and their relationship to insomnia symptoms. Analysis was limited to 99 patients who reported baseline cognitive difficulties. Interventions were delivered over 8 weeks. Objective attention, learning, and memory were evaluated using the Buschke Selective Reminding Test. Subjective cognitive function was assessed using the Brown Attention-Deficit Disorder Scales. Insomnia symptoms were assessed using the Insomnia Severity Index. All outcomes were collected at baseline, week 8, and week 20. RESULTS From baseline to week 8, acupuncture produced statistically significant within-group improvements in objective attention (Cohen D, 0.29), learning (Cohen D, 0.31), and memory (Cohen D, 0.33) that persisted to week 20 (all P

Background People with lung cancer are interested in using herbs for symptom management. However, well-designed clinical trials are lacking. We aimed to quantify symptom burden and willingness to participate in herbal clinical trials among this population. Methods We conducted a cross-sectional analysis using data collected from people with lung cancer at an oncology clinic at an academic cancer center. The primary outcome was self-reported willingness to participate in herbal research. We measured symptoms using the MD Anderson Symptom Inventory (MDASI). Multivariate logistic regression was performed to explore the relationship between demographic/ clinical factors, symptom burden, and willingness to participate in herbal studies. Results Among 288 participants, 55% were female, 42% were >65 years, 54% had stage IV cancer, and 86% had non-small cell lung cancer (NSCLC). Nearly half (46%) indicated willingness to participate in an herbal clinical trial. The most commonly reported moderate to severe symptoms (≥4 on the MDASI scale) were fatigue (57%), drowsiness (44%), disturbed sleep (43%), distress (42%), and dyspnea (36%). In multivariate analyses, higher education was significantly associated with willingness to participate in herbal studies (adjusted odds ratio 1.87, 95% confidence interval, 1.12-3.10, P=0.016), while symptom burden was not. Conclusions People with lung cancer experience high rates of symptom burden. Nearly half of our participants expressed willingness to participate in an herbal clinical trial, particularly those with higher education. These findings can inform the design of future herbal clinical trials targeting common symptoms in lung cancer populations.

Objective Because hot flashes are a common symptom experienced by women with breast cancer, we sought to explore genetic predictors associated with response to acupuncture for the treatment of hot flashes. Methods Using data from our completed randomized controlled trial (Clinicaltrials.gov identifier: NCT01005108) on hot flashes among breast cancer survivors who provided biomarker collection (N = 108), we extracted and assayed DNA for single nucleotide polymorphisms in genes involved in neurotransmission, thermoregulation, and inflammation (ADORA1, COMT, TCL1A, and TRPV1). For our primary outcome we classified individuals with a 50% or more reduction in their hot flash composite score at the end of treatment as responders. We used Fisher exact test to identify individual and combined single nucleotide polymorphisms associated with treatment response. Results Among women (N = 57) who received acupuncture treatment (electro or sham), we found that women who were carriers of at least one of these six genotypes (ADORA1 rs41264025-GA or rs16851029-GG or rs12744240-GT, COMT rs6269-GA, TCL1A rs2369049-GG, and TRPV1 rs8065080-TT) were more likely to respond to acupuncture for hot flashes than noncarriers (70.3% vs 37.5%, P = 0.035). These six genotypes were not associated with response in women (N = 51) who received pharmacological hot flash treatment (gabapentin or placebo pill; 37.5% vs 37.5%, P = 1.0). Conclusions In this exploratory, proof of concept study, we identified six genotypes that may predict response to acupuncture for hot flashes in breast cancer survivors. If confirmed by future studies, these findings may inform the development of personalized acupuncture for managing hot flashes.

Chronic inflammation has been a proposed mechanism of resistance to aromatase inhibitors in breast cancer. Stratifying by HER2 status, a matched case-control study from the Wellness After Breast Cancer-II cohort was performed to assess whether or not elevated serum inflammatory biomarkers (C-Reactive protein [CRP], interleukin-6 [IL-6], and serum amyloid A [SAA]) and/or the presence of a high-risk IL-6 promoter genotype were associated with recurrence of hormone receptor positive (HR+) early breast cancer. Estrogen levels were also measured and correlated with biomarkers and disease outcomes. CRP and SAA were significantly associated with an increased risk of recurrence in the HR+/HER2− group, but not the HR+/HER2+ group. Mean serum estrogen levels were non-significantly elevated in patients who relapsed vs. non-relapsed patients. Surprisingly, high-risk IL-6 promoter polymorphisms were strongly associated with HER2+ breast cancer relapse, which has potential therapeutic implications, as elevated intracellular IL-6 has been associated with trastuzumab resistance in pre-clinical models.

OBJECTIVES: Insomnia is common among cancer survivors, yet survivors’ beliefs about their insomnia following cancer are largely unknown. This study describes cancer survivors’ causal attributions of insomnia and whether these beliefs differ by sociodemographic characteristics. PARTICIPANTS: 160 cancer survivors meeting diagnostic criteria for insomnia disorder. METHODS: Survivors endorsed how likely they believed 12 different factors were causally related to their insomnia and self-reported sociodemographics. Multinomial logistic regression tested associations between attribution endorsement and sociodemographics. Latent class analysis (LCA) examined patterns of attribution endorsement and whether sociodemographics were associated. RESULTS: 154 survivors (96%) endorsed that at least 1 causal attribution was likely related to their insomnia. Most survivors endorsed that emotions (77%), thinking patterns (76%), sleep-related emotions (65%), and sleep-related thoughts (57%) were related to their insomnia, similar to data previously published among healthy persons with insomnia. Younger participants were more likely to endorse that biochemical factors related to their insomnia (ps

Background Supportive care is a critical component of the treatment of cancer patients that is underutilized; patient lack of information about these services is an important barrier. Mobile technologies may be useful tools for delivering information, but cancer patient use of and interest in using them to learn about supportive care services have not been described. This study evaluates factors associated with cancer patient use of mobile technologies and interest in smartphone applications for information delivery about supportive care. Methods We conducted a cross‐sectional survey among cancer patients from one urban academic hospital and 11 community hospitals. Patients self‐reported use of mobile technologies and interest in smartphone applications. Multivariate logistic analysis was used to identify determinants of mobile technology use and smartphone interest. Results Among 631 participants, 466 (74%) reported regular use of mobile devices and 242 (39%) expressed an interest in supportive care information via smartphone applications. Patients under 45 were more likely to use a mobile device (Adjusted Odds Ratio [AOR] 6.8, 2.8‐16.9 95% CI, P

Yoga has been shown to improve cancer survivors' quality of life, yet regular yoga practice is a challenge for those who are sedentary. We conducted a pilot randomized controlled study to assess feasibility and adherence of two types of yoga intervention among sedentary cancer survivors. Sedentary breast and ovarian cancer survivors were randomized to practice either restorative yoga (minimal physical exertion, Group R) or vigorous yoga (considerable physical exertion, Group V) in three 60-minute supervised sessions a week for 12 weeks, followed by 12 weeks of home practice. Accrual, adherence, and attendance rates were assessed. Of the 226 eligible patients, 175 (77%) declined to participate in the study, citing time commitment and travel as the most common barriers. Forty-two subjects consented to participate in the study. Of the 35 participants who began the intervention (20 in Group R and 15 in Group V), adherence rate (percentage remaining in the study at week 12) was 100% and 87%, respectively. Rate of adequate attendance (more than 66% of the scheduled supervised sessions) was 85% and 73%, respectively. Rate of completion of the home practice period was 85% and 77%, respectively. In this study, sedentary cancer survivors were able to adhere to a long-term, regular yoga regimen. The rate of adequate attendance was higher for restorative yoga. Future studies for sedentary patients should focus on reducing time commitment and travel requirements to improve recruitment, and on using restorative yoga as a more feasible intervention for this population.

Background: Traditional Chinese medicine (TCM) is widely used among Chinese cancer patients. However, little is known about Chinese patients’ expectations and barriers toward using TCM for cancer. Methods: We conducted a cross-sectional survey within a patient-support group, the Beijing Anti-Cancer Association. We measured the outcome, Chinese cancer survivors’ expectations and barriers toward TCM utilization, using a modified version of ABCAM (Attitudes and Beliefs towards Complementary and Alternative Medicine), the ABTCM (Attitudes and Beliefs towards Traditional Chinese Medicine). We used multivariate models to evaluate the impact of socioeconomic status and clinical factors on their expectations and barriers (including treatment concerns and logistical challenges domain) toward TCM. Results: Among 590 participants, most patients expected TCM to boost their immune system (96%), improve their physical health (96%), and reduce symptoms (94%). Many had logistical challenges (difficulty decocting herbs (58%) and finding a good TCM physician (55%)). A few were concerned that TCM might interfere with conventional treatments (7.6%), and that many TCM treatments are not based on scientific research (9.1%). In the multivariable regression model, age ≤60 years was independently associated with higher expectation score ( P = .031). Age ≤60 years (coefficient 5.0, P = .003) and localized disease (coefficient 9.5, P = .001) were both associated with higher treatment concerns. Active employment status (coefficient 9.0, P = .008) and localized disease (coefficient 7.5, P = .030) were related to more logistical challenges. Conclusion: Age and cancer stage were related to Chinese cancer patients’ perceived expectations and barriers toward TCM use. Understanding these attitudes is important for reshaping the role that TCM plays in China’s patient-centered comprehensive cancer care model.

ObjectiveInsomnia is underrecognized and inadequately managed, with close to 60% of cancer survivors experiencing insomnia at some point in the treatment trajectory. The objective of this study was to further understand predisposing, precipitating, and perpetuating factors in the development and maintenance of insomnia in cancer survivors.MethodA heterogeneous sample of 63 patients who had completed active treatment was recruited. Participants were required to have a score >7 on the Insomnia Severity Index and meet the diagnostic criteria for insomnia disorder. Open-ended, semistructured interviews were conducted to elicit participants’ experiences with sleep problems. An a priori set of codes and a set of codes that emerged from the data were used to analyze the data.ResultThe mean age of the sample was 60.5 years, with 30% identifying as non-white and 59% reporting their sex as female. The cancer types represented were heterogeneous with the two most common being breast (30%) and prostate (21%). Participants described an inherited risk for insomnia, anxious temperament, and insufficient ability to relax as predisposing factors. Respondents were split as to whether they classified their cancer diagnosis as the precipitating factor for their insomnia. Participants reported several behaviors that are known to perpetuate problems with sleep including napping, using back-lit electronics before bed, and poor sleep hygiene. One of the most prominent themes identified was the use of sleeping medications. Participants reported that they were reluctant to take medication but felt that it was the only option to treat their insomnia and that it was encouraged by their doctors.Significance of resultsInsomnia is a prevalent, but highly treatable, disorder in cancer survivors. Patients and provider education is needed to change individual and organizational behaviors that contribute to the development and maintenance of insomnia and increase access to evidence-based nonpharmacological interventions.

PURPOSE: Patients with cancer frequently experience symptoms such as fatigue and pain that can influence their ability to maintain their usual physical activity (PA). This study aimed to evaluate whether symptoms of fatigue and pain are associated with decreased PA among patients with cancer. METHODS: We recruited patients with a cancer diagnosis from one academic medical center and 11 affiliated community hospitals to participate in a cross-sectional survey. Multivariate logistic regression models were used to examine the association between symptoms, demographics, and clinical characteristics and decreased PA since cancer diagnosis. RESULTS: Among 629 participants, 499 (79%) reported a decreased level of PA since their cancer diagnosis. In the past seven days from the time of the survey, 78% of participants reported moderate to very severe fatigue, and 68% reported a pain level 4 or greater on a scale of 0 to 10. Adjusted for covariates, patients with fatigue (Adjusted Odds Ratio, AOR 4.01, 95% CI 2.41-6.65) and pain (AOR 1.89, 95% CI 1.14-3.12) had higher odds of reporting decreased PA since diagnosis. Receipt of chemotherapy or currently receiving active cancer treatment was also associated with decreased PA (p

Objective To evaluate the associations between polymorphisms in two genes, catechol-O-methyltransferase and T-cell leukemia/lymphoma 1 A, and acupuncture-mediated pain reduction among breast cancer survivors with aromatase inhibitor-associated arthralgia. Design, setting, and subjects Biospecimens were obtained from 38 patients enrolled in a clinical trial of acupuncture for aromatase inhibitor-associated arthralgia in postmenopausal hormone receptor-positive breast cancer survivors. Methods We used polymerase chain reaction to genotype the rs4680 (Val158Met) and rs4633 (His62His) variants in the catechol-O-methyltransferase gene and rs2369049 (A > G) and rs7158782 (A > G) variants in the T-cell leukemia/lymphoma 1 A gene. Response to acupuncture was defined by 30% reduction in end-of-treatment average pain, measured by the Brief Pain Inventory. We used Fisher exact tests to evaluate associations between genotype and treatment response. Results Among participants, all six (15.8%) subjects who expressed AA in locus rs4680 responded to acupuncture. In a combined analysis, the 18 (47.4%) subjects with the responder genotype at either rs4680 (AA) or rs2369049 (GG or AG) were significantly more likely to respond to acupuncture than those without (77.8% vs 45.0%, P = 0.039). Conclusions Specific genetic variations at loci rs4680 and rs2369049 are associated with response to acupuncture-type intervention for management of arthralgia. These results serve as a proof of concept for applying a precision medicine framework to the study of cancer pain management.

PURPOSE: Breast cancer treatments may lead to chronic pain. For some breast cancer survivors (BCS), this experience can develop into the perception of living with chronic pain. The majority of BCS are postmenopausal and have hormone receptor-positive (HR+) breast cancer requiring aromatase inhibitors (Als). Neither the prevalence nor risk factors associated with the perception of living with chronic pain among this population are well defined. METHODS: We conducted a cross-sectional survey among postmenopausal, HR+ BCS who previously took or were currently taking Als. The primary outcome was patients’ perception of living with chronic pain over the past 6 months. We measured pain and demographic and clinical variables. Multivariable logistic regression analysis was performed to evaluate risk factors associated with the perception of chronic pain. RESULTS: Among 1280 participants, 167 (13%) reported having the perception of living with chronic pain before their breast cancer diagnosis; 426 (34%) reported this perception after completion of non-hormonal cancer treatment. Seventy-eight percent of BCSs reported experiencing at least one type of treatment-related pain within the past 7 days, with 23% experiencing at least three types. The most common types of pain were Al-induced musculoskeletal pain (49%) and pain at the surgery or radiation site (31%). Younger age (< 56), BMI > 25, and the perception of living with chronic pain before diagnosis were risk factors associated with the perception of living with chronic pain. CONCLUSIONS: One in three postmenopausal, HR+ BCS considered themselves to be living with chronic pain. Effective interventions to reduce chronic pain are needed.

Objective:Sleep disturbance is a major consequence of hot flashes among breast cancer survivors. This study evaluated the effects of electro-acupuncture (EA) versus gabapentin (GP) for sleep disturbances among breast cancer survivors experiencing daily hot flashes.Methods:We analyzed data fr

Objective: This article reports on the development, implementation, and evaluation of an integrative clinical oncology massage program for patients undergoing chemotherapy for breast cancer in a large academic medical center. Materials and Methods: We describe the development and implementation of an oncology massage program embedded into chemoinfusion suites. We used deidentified program evaluation data to identify specific reasons individuals refuse massage and to evaluate the immediate impact of massage treatments on patient-reported outcomes using a modified version of the Distress Thermometer delivered via iPad. We analyzed premassage and postmassage data from the Distress Thermometer using paired t test and derived qualitative data from participants who provided written feedback on their massage experiences. Results: Of the 1,090 massages offered, 692 (63%) were accepted. We observed a significant decrease in self-reported anxiety (from 3.9 to 1.7), nausea (from 2.5 to 1.2), pain (from 3.3 to 1.9), and fatigue (from 4.8 to 3.0) premassage and postmassage, respectively (all P < .001). We found that 642 survey participants (93%) were satisfied with their massage, and 649 (94%) would recommend it to another patient undergoing treatment. Spontaneous patient responses overwhelmingly endorsed the massage as relaxing. No adverse events were reported. Among the 398 patients (36%) who declined a massage, top reasons were time concerns and lack of interest. Conclusion: A clinical oncology massage program can be safely and effectively integrated into chemoinfusion units to provide symptom control for patients with breast cancer. This integrative approach overcomes patient-level barriers of cost, time, and travel, and addresses the institutional-level barrier of space.

Introduction: Breast cancer treatments may result in acute pain that, if untreated or undertreated, may lead to chronic pain. Twenty to thirty percent of patients who undergo mastectomy experience post-mastectomy pain syndrome, and up to 50% of breast cancer survivors taking aromatase inhibitors (AI) report aromatase inhibitor associated arthralgia (AIAA). The rates, experiences, and risk factors of the effects of breast cancer treatment on breast cancer survivors' perceptions of chronic pain are not well defined. Methods: We conducted a cross-sectional survey among postmenopausal, hormone receptor-positive, breast cancer survivors who were currently taking or had previously taken an AI. The main outcome variable was the patient's perception of living with chronic pain. Variables including breast cancer treatment, socioeconomic and clinical factors, symptom burden, pain (measured by the Brief Pain Inventory [BPI]), and pain-related coping (measured by the Pain Catastrophizing Scale [PCS]) were measured. Univariate and multivariate logistic analyses were performed to identify the risk factors associated with patients' perceptions of living with chronic pain. Results: Among 561 participants, 62 (11.1%) reported that they perceived themselves as living with chronic pain prior to their breast cancer diagnosis and 172 (30.8%) reported living with chronic pain during the past 6 months at the time of the survey. Compared with patients who did not perceive chronic pain, patients with the perception of chronic pain had significantly higher pain severity (4.15±0.17 vs. 1.54±0.09) and interference (3.47±0.2 vs. 0.97±0.08); higher pain medication usage (percentage of patients taking at least one pain medication over the past 7 days: 85.47% vs. 57.36%); and higher levels of negative coping with pain, including rumination (4.08±0.31 vs. 2.28±0.16), magnification (2.27±0.2 vs. 1.15±0.08), and helplessness (4.63±0.37 vs. 1.64±0.13). Among participants, 369 (65.78%) reported taking at least one pain medication over the past 7 days. In a multivariate analysis, age (70), higher BMI (>30), prior chemotherapy, currently experiencing AIAA, and the presence of chronic pain before cancer diagnosis were identified as risk factors associated with the perception of living with chronic pain. Conclusion: One in three breast cancer survivors considered themselves to be living with chronic pain, and two-thirds developed such perceptions following their cancer diagnosis. Both chemotherapy and AI use were risk factors for perceptions of chronic pain. Those women who had chronic pain experienced greater pain severity, daily interference, and more negative coping. Better understanding of the risk factors and symptom burden associated with chronic pain perceptions among this population may allow for more targeted interventions to reduce chronic pain and its negative sequelae, including premature termination of AI treatment. Citation Format: Bao T, Seluzicki C, Li Q, Mao J. The perception of chronic pain among breast cancer survivors [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-13-08.

Background:Aromatase inhibitors (AIs) are associated with reduced risk of breast cancer recurrence, yet many women discontinue their treatment prematurely, often due to arthralgia. Empirically, breast cancer survivors who experience AI-associated arthralgia often report that they have aged quickly over a short period of time. Objective: We aimed to determine whether survivors with a heightened sense of aging due to arthralgia were more likely to non-adhere to their AI regimen. Methods: We conducted a prospective cohort study in an urban academic cancer center among post-menopausal women with hormone receptor positive breast cancer who were within the first two years of their aromatase inhibitor therapy. Perceptions of aging due to arthralgia were measured by the previously validated Penn Arthralgia Aging Scale. Non-adherence was defined as interrupting treatment or discontinuing the AI before the prescribed treatment length was over. Trained raters abstracted adherence data from medical charts. We performed Cox proportional hazards regression to evaluate the relationship between perceptions of aging due to arthralgia and time to non-adherence while adjusting for potential confounders. Results: Among 509 participants, most were White (81.2%) and had at least some college education (77.9%). The majority had been prescribed anastrozole (88.0%), followed by letrozole (9.0%), and exemestane (3.0%). During the follow up period, 144 (28.3%) did not adhere to the AIs as originally prescribed. In univariate analysis, women with a heightened sense of aging due to arthralgia were at more than twice the risk of non-adherence compared to women with low levels of aging perceptions (Hazard Ratio [HR], 2.20; 95% CI, 1.50 – 3.21; p < 0.001). After adjusting for arthralgia pain severity, depression, and AI type, aging perceptions remained a statistically significant predictor of adherence (HR, 1.71; 95% CI, 1.10-2.67; p = 0.02). Depression status also uniquely predicted non-adherence risk (HR, 1.63; 95% CI, 1.03 – 2.59; p = 0.04). Arthralgia pain severity, which predicted adherence in univariate analysis, was not a significant predictor in the final model (HR, 1.21; 95% CI, 0.84 – 1.75; p = .30). Conclusions: Breast cancer survivors on AIs who have a heightened sense of aging due to arthralgia are at greater risk of non-adhering to their AI regimen. Interventions are needed to help survivors reduce arthralgia and develop adaptive appraisals of their AI experience to achieve optimal adherence. Citation Format: Mao JJ, Chambless DL, Chen J, Bao T, Brier MJ. Arthralgia-associated aging perceptions predict adherence to aromatase inhibitors among women with breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-13-16.

Introduction Treatment-related joint pain affects almost half of all women with breast cancer using aromatase inhibitors and is a major reason for terminating treatment. Although acupuncture is becoming an increasingly popular, evidence-based option for treating pain, little is known about the potential influence of psychological factors on acupuncture use. Objective We aimed to evaluate the association between pain catastrophising and use of acupuncture in breast cancer survivors experiencing arthralgia. Methods We conducted a cross-sectional survey of arthralgic breast cancer patients. Patients were asked if they had used acupuncture since their cancer diagnosis. The Pain Catastrophising Scale (PCS) was used to measure negative coping styles related to the experience of pain. We performed multiple logistic regression analysis to evaluate the relationship between pain catastrophising and acupuncture use, adjusting for covariates. Results Of the 424 participants, 69 (16%) reported use of acupuncture since their breast cancer diagnosis. In multivariate analyses, compared to those in the lowest PCS score tertile, patients with the highest PCS scores were more likely to have used acupuncture (p=0.03). In particular, patients with high levels of rumination (p=0.005) and magnification (p=0.008) were more likely to have used acupuncture. Helplessness was not associated with acupuncture use (p=0.23). Conclusions High levels of pain catastrophising, and specifically the processes of rumination and magnification, were associated with greater acupuncture use. We believe this could have important implications for understanding which population is more likely to seek acupuncture treatment and how this alternative therapy could be better targeted to these patients.

Background Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects. Purpose To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse. Methods Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center. During Phase 1, eligible participants received 12 weeks of open-label therapy with chamomile pharmaceutical grade extract 1500 mg (500 mg capsule 3 times daily). During Phase 2, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo in a double-blinded, placebo-substitution design. The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Secondary outcomes included the proportion who relapsed, treatment-emergent adverse events, and vital sign changes. This study is registered at ClinicalTrials.gov, identifier NCT01072344. Results Between March 1, 2010, and June 30, 2015, we enrolled 179 participants. Of those, 93 (51.9%) were responders and agreed to continue in the double-blind randomized controlled trial. A numerically greater number of placebo-switched (n = 12/47; 25.5%) versus chamomile-continuation (n = 7/46; 15.2%) participants relapsed during follow-up. Mean time to relapse was 11.4 ± 8.4 weeks for chamomile and 6.3 ± 3.9 weeks for placebo. Hazard of relapse was non-significantly lower for chamomile (hazard ratio, 0.52; 95% CI, 0.20–1.33; P = 0.16). During follow-up, chamomile participants maintained significantly lower GAD symptoms than placebo (P = 0.0032), with significant reductions in body weight (P = 0.046) and mean arterial blood pressure (P = 0.0063). Both treatments had similar low adverse event rates. Conclusions Long-term chamomile was safe and significantly reduced moderate-to-severe GAD symptoms, but did not significantly reduce rate of relapse. Our limited sample size and lower than expected rate of placebo group relapse likely contributed to the non-significant primary outcome finding. Possible chamomile superiority over placebo requires further examination in large-scale studies.

Objectives: Evidence indicates there are beneficial physical and psychosocial effects from practicing yoga in cancer patients and survivors. Despite yoga having been incorporated into National Comprehensive Cancer Network guidelines for symptoms ranging from fatigue to pain, patients' use of yoga for supportive care is low, ranging from 6% to 12%. This study aims to evaluate the awareness of yoga as therapy in an academic cancer center and the preferences for information delivery in this population. Design: We conducted a cross-sectional survey study at an urban academic cancer center. Responses regarding awareness and use of yoga were evaluated; those responding “not aware” were analyzed for preferences in information delivery. Univariate analysis was used to further characterize awareness of yoga for supportive care. Results: Of 303 respondents, 68% were female, 77% were white, and 75% were college educated. Despite access to yoga at the cancer center, 171 (56%) patients expressed they were not aware of the availability of yoga. Male patients were more likely to be unaware of yoga (72.4% vs. 48.8%, p = 0.045). Awareness did not vary by age, race, educational attainment, marital status, cancer type, or cancer stage. Of the 171 “not aware” patients, 87.6% expressed desire for information in the form of printed material, followed by 80.4% for e-mail, 37.6% for smartphone application, and 27.6% for social media. Non-white respondents were more likely to express interest in receiving information by smartphone. Conclusions: More than half of cancer patients were unaware of the yoga program despite advertising across the institution. Patients prefer varying methods for information receipt, with preferences differing by sociodemographic factors. Targeted education and outreach using appropriate engagement is needed to improve the awareness of yoga for symptom control in cancer patients.

PurposeBreast cancer survivorship care plans (SCP) have limited content addressing women's health issues. This trial tested if young breast cancer survivors who receive a web-based, women's health SCP were more likely to improve on at least one of the four targeted issues (hot flashes, fertility-related concerns, contraception, and vaginal symptoms) compared to attention controls.MethodsA randomized controlled trial recruited female survivors ages 18-45 at diagnosis, 18-50 at enrollment, completed primary cancer treatment, and had a significant women's health issue: moderate or higherfertility-related concerns; ≥ 4 hot flashes/day with ≥ 1 of moderate severity; ≥ 1 moderate vaginal atrophy symptoms; or not contracepting/using less effective methods. Survivors underwent stratified, block randomization with equal allocation to intervention and control groups. The intervention group accessed the online SCP; controls accessed curated resource lists. In intention-to-treat analysis, the primary outcome of improvement in at least one issue by 24weeks was compared by group.Results182 participants (86 intervention, 96 control), mean age 40.0 ± 5.9 and 4.4 ± 3.2years since diagnosis, were randomized. 61 intervention group participants (70.9%) improved, compared to 55 controls (57.3%) (OR 1.82, 95% CI 0.99-3.4, p = 0.057). The following issue-specific improvements were observed in the intervention versus control arms: fertility-related concerns (27.9% vs. 14.6%, OR 2.3, 95% CI 1.1-4.8); hot flashes (58.5% vs. 55.8%, OR 1.1, 95% CI 0.57-2.2); vaginal symptoms (42.5% vs. 40.7%, OR 1.1, 95% CI 0.6-2.0); contraception (50% vs. 42.6%, OR 1.4, 95% CI 0.74-2.5).ConclusionsIn young breast cancer survivors, a novel, web-based SCP did not result in more change in the primary outcome of improvement in at least one of the four targeted women's health issues, than the attention control condition. The intervention was associated with improved infertility concerns, supporting efficacy of disseminating accessible, evidence-based women's health information to this population.

OBJECTIVE: To study the relationship between cancer patient/research participants’ perceptions of communication with their research nurse and doctor and 1) participants’ thoughts of dropping out from their cancer clinical trials (CCTs), 2) how informed they felt before and during their clinical trial participation, and 3) trust in their researchers. METHODS: We surveyed 110 adult cancer patients who were enrolled in cancer clinical trials by using 15 modified items from the Medical Communication Competence Scale measuring information exchange and relational communication. Retention was measured by two items: ever thought about dropping out (yes/no) and likelihood of remaining enrolled in the clinical trial (5-point Likert item). We asked how well informed about the trial participants felt at enrollment, at the date they filled out the survey, and about changes in the trial. RESULTS: Patient-participants with thoughts of dropping out from their CCTs rated their communication with research doctors lower than those who did not have thoughts of dropping out (4.14 versus 4.46, t=2.22, p=0.03). Patient-participants’ intention to remain enrolled was correlated with more favorable scores on relational communication (such as contributing to a trusting relationship and showing compassion) with research doctors (r=0.20, p=0.04) and nurses (r=0.25, p=0.01). Communication with doctors was also associated with how informed patient-participants felt during their clinical trials. CONCLUSIONS: Relational communication with research doctors and nurses was significantly related to thoughts about remaining enrolled or dropping out of a clinical trial among adult participants in cancer treatment clinical trials. PRACTICE IMPLICATIONS: Relational skills with cancer patients advances communication in research.

Background Cancer-related cognitive impairment is an emerging public health burden. Growing research suggests that sleep disturbances contribute to poor cognition. Our study aimed to evaluate the association between insomnia and cognitive impairment in breast cancer survivors. Methods We analyzed cross-sectional data from a cohort study of postmenopausal women with stage 0–III hormone receptor-positive breast cancer on aromatase inhibitor therapy. The study was conducted between November 2011 and April 2015 at an academic cancer center (Philadelphia, PA). Insomnia was assessed with the Insomnia Severity Index. Perceived cognitive impairment was assessed with the cognitive subscale of the Breast Cancer Prevention Trial Symptom Checklist. We used linear regression to evaluate the association between insomnia and perceived cognitive impairment. Results Among 1072 patients, 556 (51.9%) reported insomnia and 847 (79.0%) were bothered by cognitive symptoms (forgetfulness, difficulty concentrating, distractibility). Greater perceived cognitive impairment was reported by patients with mild insomnia (regression coefficient [β] = 0.35, 95% confidence interval [CI] = 0.23 to 0.46, P Conclusions Among postmenopausal breast cancer survivors receiving aromatase inhibitor therapy, insomnia and cognitive impairment are prevalent and characterized by a graded association, in which severity of perceived cognitive impairment increases as insomnia severity increases. Our findings warrant further research to determine whether addressing sleep is a strategy to improve management of cancer-related cognitive impairment.

This paper aims to discuss the challenges faced during a pilot study that tested a technology-based cancer pain management program among Asian American survivors of breast cancer and provide directions for future technology-based interventions for racial and ethnic minorities. Data consisting of research diaries and meeting minutes underwent content analysis to extract themes that reflected the challenges. The challenges included those related to: (1) diversities within the population of Asian American survivors of breast cancer; (2) survivors’ treatment and healing process; (3) Internet resources from the participants’ countries of origin; (4) building trust between researchers and participants and gatekeepers; (5) fidelity of the intervention; and (6) cultural sensitivity. Future design and implementation of technology-based programs for racial and ethnic minorities must consider these challenges.