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1.  Antiemetic prescribing practices using a computerized physician order entry system 
Adherence to guideline-consistent chemotherapy-induced nausea and vomiting (CINV) prophylaxis is suboptimal. The primary aim of this study was to evaluate the magnitude of compliance to institutional guideline-directed antiemetic prophylaxis using a computerized physician order entry system at a single tertiary care institution. A nurse survey was also performed to evaluate how oncology practices, within a cooperative group, managed clinician orders for the prevention of CINV.
The electronic medical records of 100 consecutive patients were evaluated. The primary endpoint was the incidence of compliance to provide all aspects of scheduled institutional guideline-directed antiemetic prophylaxis for acute (day 1) and delayed (days 2–4) CINV. A descriptive analysis was performed on the convenience sample. Logistic regression was completed to determine the predictors of noncompliance.
The incidence of compliance on days 1–4 was 94 %. Half of the noncompliant events (three of six, 50 %) occurred on day 1 alone and involved patients receiving low-emetogenic chemotherapy. There was a high degree of compliance to institutional guidelines for the treatment of delayed CINV (97 %). Patients receiving minimally emetogenic and moderately emetogenic chemotherapy (N =70) were observed to be 100 % compliant. Patients receiving doxorubicin/cyclophosphamide were numerically less likely to receive institutional guidelines, compared to patients receiving other chemotherapy regimens (OR, 0.24 (0.04, 1.36), p value, 0.05). The nurse survey suggested significant variability amongst the involved institutions with regards to antiemetic prescribing practices.
Computerized physician order entry is associated with impressive adherence to clinician-prescribing practices, according to institutional guidelines, for acute and delayed CINV.
PMCID: PMC3983561  PMID: 24026983
Chemotherapy-induced nausea and vomiting; Acute CINV; Delayed CINV; Antiemetics; Computerized physician order entry
2.  The Relationship between Communication and Health-related Quality of Life in Survivorship Care for Chinese- and Korean-American Breast Cancer Survivors 
The purpose of this study was (1) to compare family communication, decision support (i.e., supporting the patient in making decisions), self-efficacy in patient-physician communication (i.e., patients’ confidence level in communicating with physicians), and health-related quality of life (HRQOL) between Chinese- and Korean-American breast cancer survivors (BCS), and (2) to investigate how family communication, decision support, and self-efficacy in patient-physician communication influences HRQOL for Chinese- and Korean-American BCS.
A cross-sectional design was used. A total of 157 Chinese- (n=86) and Korean-American (n=71) BCS were recruited from the California Cancer Surveillance Program and area hospitals in Los Angeles County. The Chronic Care Model was utilized.
Chinese- and Korean-Americans showed a significant difference in the decision support only. Self-efficacy in patient-physician communication was directly associated with HRQOL for Chinese-Americans, whereas for Korean-Americans, family communication was related to HRQOL. The mediating effects of decision support and self-efficacy in physician-patient communication in the relationship between family communication and HRQOL were observed for Chinese-Americans only. Multiple group analysis demonstrated that the structural paths varied between Chinese- and Korean-American BCS.
Our results provide insight into the survivorship care of Chinese- and Korean-American BCS, allowing a better understanding of communication among survivors, family, and healthcare providers. Communication skills to manage conflict and attain consensus among them under the cultural contexts are essential to improve HRQOL for BCS.
PMCID: PMC3574173  PMID: 23111944
Asian-American; Breast cancer survivors; Decision support; Efficacy in patient-physician communication; Family communication; Health-related quality of life
3.  The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9 
Patients undergoing treatment for cancer often report problems with their cognitive function, which is an essential component of health-related quality of life. Pursuant to this, a two-arm randomized, placebo-controlled, double-blind, phase III clinical trial was conducted to evaluate Ginkgo biloba (EGB 761) for the prevention of chemotherapy-related cognitive dysfunction in patients with breast cancer.
Previously chemotherapy naïve women about to receive adjuvant chemotherapy for breast cancer were randomized to receive 60 mg of EGB 761 or a matching placebo twice daily. The study agent was to begin before their second cycle of chemotherapy and to be taken throughout chemotherapy and 1 month beyond completion. The primary measure for cognitive function was the High Sensitivity Cognitive Screen (HSCS), with a secondary measure being the Trail Making Tests (TMT) A and B. Subjective assessment of cognitive function was evaluated by the cognitive subscale of the Perceived Health Scale (PHS) and the Profile of Mood States (POMS). Data were collected at baseline and at intervals throughout and after chemotherapy, up to 24 months after completion of adjuvant treatment. The primary statistical analysis included normalized area under the curve (AUC) comparisons of the HSCS, between the arms. Secondary analyses included evaluation of the other measures of cognition as well as correlational analyses between self-report and cognitive testing.
One hundred and sixty-six women provided evaluable data. There were no significant differences in AUC up to 12 months on the HSCS between arms at the end of chemotherapy or at any other time point after adjuvant treatment. There were also no significant differences in TMT A or B at any data point. Perceived cognitive functions, as measured by the PHS and confusion/bewilderment subscale of the POMS, were not different between arms at the end of chemotherapy. There was also little correlation between self-reported cognition and cognitive testing. No differences were observed in toxicities per Common Terminology Criteria for Adverse Events (CTCAE) assessment between Ginkgo biloba and placebo throughout the study; however, after chemotherapy, the placebo group reported worse nausea (p = .05).
This study did not provide any support for the notion that Ginkgo biloba, at a dose of 60 mg twice a day, can help prevent cognitive changes from chemotherapy. These analyses do provide data to further support the low associations between patients’ self-report of cognition and cognitive performance, based on more formal testing.
PMCID: PMC3587364  PMID: 23150188
Ginkgo biloba; Chemotherapy-related cognitive dysfunction; Adjuvant treatment; Breast cancer; Dietary supplements
4.  Predictors of high score patient-reported barriers to controlling cancer pain: a preliminary report 
Pain is one of the most common and devastating symptoms in cancer patients, and misunderstandings on the patient’s part can cause major obstacles in pain management.
We evaluated factors associated with patient’s high barrier score to managing cancer-associated pain by having 201 patients complete the Korean Barriers Questionnaire II, the Brief Pain Inventory—Korean, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and the Korean Beck Depression Inventory. The Pain Management Index (PMI) was also assessed.
The patients were from nine oncology clinics in university hospitals and a veterans’ hospital in South Korea. The median pain score (0–10 scale) was 4, with a median percentage of pain improvement during the last 24 h of 70 %. A total of 150 patients (75 %) received strong opioids, and 177 (88 %) achieved adequate analgesia (positive PMI). Mean scores ± SD for the Barriers Questionnaire II ranged from 1.5 ± 1 to 2.8 ± 1.1, with the harmful effects subscale the highest. In the multiple regression model, depression was significantly associated with total barrier score to pain management (p < 0.0001). Pain reduction was significantly associated with the fatalism subscale.
Depression was associated with high barrier score in patients with cancer pain. Management of cancer pain should include screening for depression, and management of depression could reduce patient-reported barriers to pain management.
PMCID: PMC3881357  PMID: 23151648
Cancer; Depression; Pain management
5.  Gastrointestinal ostomies and sexual outcomes: a comparison of colorectal cancer patients by ostomy status 
Research examining effects of ostomy use on sexual outcomes is limited. Patients with colorectal cancer were compared on sexual outcomes and body image based on ostomy status (never, past, and current ostomy). Differences in depression were also examined.
Patients were prospectively recruited during clinic visits and by tumor registry mailings. Patients with colorectal cancer (N = 141; 18 past ostomy; 25 current ostomy; and 98 no ostomy history) completed surveys assessing sexual outcomes (medical impact on sexual function, Female Sexual Function Index, International Index of Erectile Function), body image distress (Body Image Scale), and depressive symptoms (Center for Epidemiologic Studies Depression Scale—Short Form). Clinical information was obtained through patient validated self-report measures and medical records.
Most participants reported sexual function in the dysfunctional range using established cut-off scores. In analyses adjusting for demographic and medical covariates and depression, significant group differences were found for ostomy status on impact on sexual function (p <.001), female sexual function (p =.01), and body image (p <.001). The current and past ostomy groups reported worse impact on sexual function than those who never had an ostomy (p <.001); similar differences were found for female sexual function. The current ostomy group reported worse body image distress than those who never had an ostomy (p <.001). No differences were found across the groups for depressive symptoms (p =.33) or male sexual or erectile function (p values≥.59).
Colorectal cancer treatment puts patients at risk for sexual difficulties and some difficulties may be more pronounced for patients with ostomies as part of their treatment. Clinical information and support should be offered.
PMCID: PMC3967444  PMID: 24091721
Colorectal cancer; Oncology; Gastrointestinal ostomies; Sexual function; Body image
6.  Surprising results regarding MASCC members' beliefs about spiritual care 
The purpose of the study was to better understand the practice and meaning of spiritual care among cancer care professionals and ultimately provide a rationale for developing internationally focused spiritual care guidelines.
We developed a 16-question survey to assess the spiritual care practices. We sent 635 MASCC members 4 e-mails each inviting them to complete the survey via an online survey service. Demographic information was collected. The results were tabulated, and summary statistics were used to describe the results.
Two hundred seventy-one MASCC members (42.7%) from 41 countries completed the survey. Of the respondents, 50.5% were age ≤50 years, 161 (59.4%) were women and 123 (45.4%) had ≥20 years of cancer care experience. The two most common definitions of spiritual care the respondents specified were “offering emotional support as part of addressing psychosocial needs” (49.8%) and “alleviating spiritual/existential pain/suffering” (42.4%). Whether respondents considered themselves to be “spiritual” correlated with how they rated the importance of spiritual care (P≤0.001). One hundred six respondents (39.1%) reported that they believe it is their role to explore the spiritual concerns of their cancer patients, and 33 respondents (12.2%) reported that they do not feel it is their role. Ninety-one respondents (33.6%) reported that they seldom provide adequate spiritual care, and 71 respondents (26.2%) reported that they did not feel they could adequately provide spiritual care.
The majority of MASCC members who completed the survey reported that spiritual care plays an important role in the total care of cancer patients, but few respondents from this supportive care focused organization actually provide spiritual care. However, in order to be able to provide a rationale for developing spiritual care guidelines, we need to understand how to emphasize the importance of spiritual care and at minimum, train MASCC members to triage patients for spiritual crises.
PMCID: PMC3951207  PMID: 23775154
Spiritual Care; Supportive Care; MASCC; Spiritual Assessment
7.  Parental Emotional Functioning Declines with Occurrence of Clinical Complications in Pediatric Hematopoietic Stem Cell Transplant 
Parents’ stress levels are high prior to their child's hematopoietic stem cell transplant (HSCT) and during transplant hospitalization, usually abating after discharge. Nevertheless, a subgroup of parents continues to experience frequent anxiety and mood disruption, the causes of which are not well understood. The purpose of this study was to assess whether clinical complications of HSCT could explain variation in parents’ recovery of emotional functioning.
Pediatric HSCT recipients (n=165) aged 5 to 18 and their parents were followed over the first year post-transplant. Health-related quality of life (HRQL) assessments and medical chart reviews were performed at each time period (baseline, 45 days, 3, 6, and 12 months). We tested the association between clinical complications (acute and chronic graft versus host disease - aGVHD and cGVHD, organ toxicity, and infection) and longitudinally measured parental emotional functioning, as assessed by the Child Health-Ratings Inventories (CHRIs). The models used maximum likelihood estimation with repeated measures.
In adjusted analyses covering the early time period (45 days and 3 months), aGVHD grade ≥ 2, intermediate or poor organ toxicity, and systemic infection were associated with decreases in mean parental emotional functioning of 5.2 (p=0.086), 5.8 (p=0.052), and 5.1 (p=0.023) points, respectively. In the later time period (6 and 12 months) systemic infection was associated with a decrease of 20 points (p<0.0001). cGVHD was not significantly associated.
When children experience clinical complications after HSCT, parental emotional functioning can be impacted. Intervening at critical junctures could mitigate potential negative consequences for parents and their children.
PMCID: PMC3540150  PMID: 22936494
Pediatric hematopoietic stem cell transplant; Parental emotional functioning; Parental distress; Transplant-related toxicity
8.  Somatic Symptoms in Cancer Patients Trajectory Over 12 Months and Impact on Functional Status and Disability 
Cross-sectional studies have established the prevalence and functional impairment of somatic symptoms in cancer patients. The purpose of this study was to determine the trajectory and adverse consequences of such symptoms over time.
Secondary analysis of longitudinal data from 405 cancer patients enrolled in a telecare management trial for pain and/or depression. Somatic symptom burden was measured with a 22-item scale at baseline, 1, 3, 6, and 12 months. Outcomes included the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, the Sheehan Disability Scale (SDS) score and self-reported total disability days (TDD). Mixed methods repeated measures (MMRM) analyses were conducted to determine whether antecedent change in somatic symptom burden predicted functional status and disability.
Symptoms were highly prevalent at baseline, with 15 of the 22 symptoms endorsed by more than half of the patients. A rather constant cross-sectional prevalence over 12 months at the group level belied a quite different trajectory at the patient level where the median persistence, resolution and incidence rates for 14 of the most common symptoms were 39%, 37%, and 24%, respectively. A clinically significant (i.e., 5 points) reduction in somatic symptom burden predicted improvement in PCS, MCS, and SDI (all P < .001), as well as a lower likelihood of ≥ 14 disability days in the past 4 weeks (odds ratio, 0.84; 95% CI, 0.74 to 0.95).
Somatic symptoms remain burdensome in cancer patients over 12 months and symptom improvement predicts significantly better functional status and less disability.
PMCID: PMC3543758  PMID: 22941116
cancer; somatic symptoms; prognosis; disability; quality of life; functional status; symptom burden
9.  Economic and Social Changes Among Distressed Family Caregivers of Lung Cancer Patients 
Although costs of lung cancer care have been documented, economic and social changes among lung cancer patients’ family caregivers have yet to be fully examined. In addition, research has not focused on caregivers with greater need for support services. This study examined various economic and social changes among distressed family caregivers of lung cancer patients during the initial months of cancer care in the United States.
Lung cancer patients’ primary family caregivers with significant anxiety or depressive symptoms were recruited from three medical centers within 12 weeks of the patient’s new oncology visit. Caregivers (N=83) reported demographic and medical information and caregiving burden at baseline. Seventy-four caregivers reported anxiety and depressive symptoms and economic and social changes three months later.
Seventy-four percent of distressed caregivers experienced one or more adverse economic or social changes since the patient’s illness. Common changes included caregivers’ disengagement from most social and leisure activities (56%) and, among employed caregivers (n=49), reduced hours of work (45%). In 18% of cases, a family member quit work or made another major lifestyle change due to caregiving. Additionally, 28% of caregivers reported losing the main source of family income, and 18% reported losing most or all of the family savings. Loss of the main source of family income and disengagement from most social and leisure activities predicted greater caregiver distress.
Findings suggest that distressed caregivers of lung cancer patients experience high rates of adverse economic and social changes that warrant clinical and research attention.
PMCID: PMC3560318  PMID: 22945881
lung cancer; family caregiving; economic; financial; employment; psychological distress
10.  Concepts and definitions for “supportive care,” “best supportive care,” “palliative care,” and “hospice care” in the published literature, dictionaries, and textbooks 
Commonly used terms such as “supportive care,” “best supportive care,” “palliative care,” and “hospice care” were rarely and inconsistently defined in the palliative oncology literature. We conducted a systematic review of the literature to further identify concepts and definitions for these terms.
We searched MEDLINE, PsycInfo, EMBASE, and CINAHL for published peer-reviewed articles from 1948 to 2011 that conceptualized, defined, or examined these terms. Two researchers independently reviewed each citation for inclusion and then extracted the concepts/definitions when available. Dictionaries/textbooks were also searched.
Nine of 32 “SC/BSC,” 25 of 182 “PC,” and 12 of 42 “HC” articles focused on providing a conceptual framework/definition. Common concepts for all three terms were symptom control and quality-of-life for patients with life-limiting illness. “SC” focused more on patients on active treatment compared to other categories (9/9 vs. 8/37) and less often involved interdisciplinary care (4/9 vs. 31/37). In contrast, “HC” focused more on volunteers (6/12 vs. 6/34), bereavement care (9/12 vs. 7/34), and community care (9/12 vs. 6/34). Both “PC” and “SC/BSC” were applicable earlier in the disease trajectory (16/34 vs. 0/9). We found 13, 24, and 17 different definitions for “SC/BSC,” “PC,” and “HC,” respectively. “SC/BSC” was the most variably defined, ranging from symptom management during cancer therapy to survivorship care. Dictionaries/textbooks showed similar findings.
We identified defining concepts for “SC/BSC,” “PC,” and “HC” and developed a preliminary conceptual framework unifying these terms along the continuum of care to help build consensus toward standardized definitions.
PMCID: PMC3781012  PMID: 22936493
Supportive care; Best supportive care; Palliative care; Hospice care; Definitions; Concepts; Terminology
11.  Prophylactic Tetracycline Does Not Diminish the Severity of Epidermal Growth Factor Receptor (EGFR) Inhibitor Induced Rash: Results from the North Central Cancer Treatment Group (Supplementary N03CB)1 
Previous studies suggest tetracycline and other antibiotics lessen the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash. This study sought to confirm such findings.
Patients starting an EGFR inhibitor were eligible for this randomized, double-blinded, placebo-controlled study and had to be rash-free. They were then randomly assigned to tetracycline 500 milligrams orally twice a day for 28 days versus a placebo. Rash development and severity (monthly physician assessment and weekly patient-reported questionnaires), quality of life (SKINDEX-16), and adverse events were monitored during the 4-week intervention and then for an additional 4 weeks. The primary objective was to compare the incidence of grade 2 or worse rash between study arms; 32 patients per group provided a 90% probability of detecting a 40% difference in incidence with a type I error rate of 0.05 (2-sided).
65 patients were enrolled, and groups were balanced on baseline characteristics. During the first 4 weeks, healthcare provider-reported data found that 27 tetracycline-treated patients (82%) and 24 placebo-exposed patients (75%) developed a rash. This rash was a grade 2+ in 17 (52%) and 14 (44%), respectively (p=0.62). Comparable grade 2+ rash rates were observed during weeks 5 through 8 as well as with patient-reported rash data throughout the study period. Quality of life was comparable across study arms, and tetracycline was well tolerated.
Although previous studies suggest otherwise, this randomized, double-blinded, placebo-controlled did not find that tetracycline lessened rash incidence or severity in patients who were taking EGFR inhibitors.
PMCID: PMC3935797  PMID: 20820817
tetracycline; rash; EGFR inhibitor; EGFR inhibitor-induced rash
12.  Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA 
This pilot trial sought to investigate whether any of three doses of American ginseng (Panax quinquefolius) might help cancer-related fatigue. A secondary aim was to evaluate toxicity.
Eligible adults with cancer were randomized in a double-blind manner, to receive American ginseng in doses of 750, 1,000, or 2,000 mg/day or placebo given in twice daily dosing over 8 weeks. Outcome measures included the Brief Fatigue Inventory, vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36), and the Global Impression of Benefit Scale at 4 and 8 weeks.
Two hundred ninety patients were accrued to this trial. Nonsignificant trends for all outcomes were seen in favor of the 1,000- and 2,000-mg/day doses of American ginseng. Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460–467 in the placebo group and 750 mg/day group versus 480–551 in the 1,000- and 2,000-mg/day arms, respectively. Change from baseline in the vitality subscale of the SF-36 was 7.3– 7.8 in the placebo and the 750-mg/day arm, versus 10.5– 14.6 in the 1,000- and 2,000-mg/day arms. Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo. There were no significant differences in any measured toxicities between any of the arms.
There appears to be some activity and tolerable toxicity at 1,000–2,000 mg/day doses of American ginseng with regard to cancer-related fatigue. Thus, further study of American ginseng is warranted.
PMCID: PMC3911883  PMID: 19415341
Panax quinquefolius; American ginseng; Cancer-related fatigue; Botanicals
13.  Distressed family caregivers of lung cancer patients: an examination of psychosocial and practical challenges 
Lung cancer and its treatment impose many demands on family caregivers, which may increase their risk for distress. However, little research has documented aspects of the caregiving experience that are especially challenging for distressed caregivers of lung cancer patients. This study aimed to explore caregivers' key challenges in coping with their family member's lung cancer.
Single, semi-structured qualitative interviews were conducted with 21 distressed family caregivers of lung cancer patients.
Caregivers described three key challenges in coping with their family member's lung cancer. The most common challenge, identified by 38 % of caregivers, was a profound sense of uncertainty regarding the future as they attempted to understand the patient's prognosis and potential for functional decline. Another key challenge, identified by 33 % of caregivers, involved time-consuming efforts to manage the patient's emotional reactions to the illness. Other caregivers (14 %) characterized practical tasks, such as coordinating the patient's medical care, as their greatest challenge.
Results suggest that clinical efforts are needed to assist distressed caregivers in providing practical and emotional support to the patient and attending to their own emotional needs.
PMCID: PMC3493687  PMID: 22797839
Family caregiver; Lung cancer; Psychological distress; Health; Quality of life
14.  Correlates of social support in young adults with advanced cancer 
This study examined the relationship between perceived social support, quality of life (QoL), and grief in young adults with advanced cancer.
Seventy-one young adults (20–40 years) with advanced cancer were administered measures of social support, QoL, and grief. Regression analyses examined the relationship between social support and QoL and grief.
Higher levels of total social support were associated with better psychological and existential QoL and less severe grief. Availability of someone to talk to about problems was also associated with better psychological and existential QoL and less severe grief. Tangible support was associated with better psychological and existential QoL. Availability of someone to engage in activities with was only associated with better existential QoL.
These results suggest that enhancing social support may improve psychological well-being in this population. In addition, specific types of social support may be particularly relevant to the psychological well-being of young adults with advanced cancer.
PMCID: PMC3613786  PMID: 22790223
Young adult; Social support; Quality of life; Grief; Cancer; Oncology
15.  Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy: placebo-controlled double-blind study of estradiol and risedronate: N01C8 
The purpose of this study is to test the ability of risedronate and estradiol, alone or in combination, to prevent bone loss associated with androgen deprivation therapy in men with prostate cancer.
Materials and methods
This is a randomized placebo-controlled trial of risedronate and estradiol, alone or in combination, in men with prostate cancer receiving androgen deprivation therapy. The primary outcome was change in hip bone mineral density at 1 year.
No statistical difference was found among the groups for bone mineral density changes. The only side effects of note were increased gynecomastia and breast tenderness associated with estrogen therapy. The study was limited by poor accrual and subsequent lack of statistical power.
Men receiving androgen deprivation therapy for prostate cancer are at risk for bone loss and should receive appropriate bone density monitoring and preventive advice about calcium, vitamin D, exercise, and fall prevention. Prescription drugs proven in this patient population should be used when the risk of fracture is high.
PMCID: PMC3903398  PMID: 19468757
Prostate cancer; Androgen deprivation therapy; Osteoporosis; Risedronate; Estradiol
16.  Employer-Sponsored Health Insurance Coverage Limitations: Results from the Childhood Cancer Survivor Study 
The Affordable Care Act (ACA) will expand health insurance options for cancer survivors in the United States. It is unclear how this legislation will affect their access to employer-sponsored health insurance (ESI). We describe the health insurance experiences for survivors of childhood cancer with and without ESI.
We conducted a series of qualitative interviews with 32 adult survivors from the Childhood Cancer Survivor Study to assess their employment-related concerns and decisions regarding health insurance coverage. Interviews were performed from August to December 2009 and were recorded, transcribed, and content analyzed using NVivo 8.
Uninsured survivors described ongoing employment limitations, such as being employed at part-time capacity, which affected their access to ESI coverage. These survivors acknowledged they could not afford insurance without employer support. Survivors on ESI had previously been denied health insurance due to their pre-existing health conditions until they obtained coverage through an employer. Survivors feared losing their ESI coverage, which created a disincentive to making career transitions. Others reported worries about insurance rescission if their cancer history was discovered. Survivors on ESI reported financial barriers in their ability to pay for health care.
Childhood cancer survivors face barriers to obtaining employer-sponsored health insurance. While Affordable Care Act provisions may mitigate insurance barriers for cancer survivors, many will still face cost barriers to affording health care without employer support.
PMCID: PMC3887442  PMID: 22717916
Employer-sponsored health insurance; childhood cancer survivors; Affordable Care Act; Insurance reform
17.  Prevalence and risk factors for insomnia among breast cancer patients on aromatase inhibitors 
Insomnia is increasingly recognized as a major symptom outcome in breast cancer; however, little is known about its prevalence and risk factors among women receiving aromatase inhibitors (AIs), a standard treatment to increase disease free survival among breast cancer patients.
A cross-sectional survey study was conducted among postmenopausal women with stage 0-III breast cancer receiving adjuvant AI therapy at an outpatient breast oncology clinic of a large university hospital. The Insomnia Severity Index (ISI) was used as the primary outcome. Multivariate logistic regression analyses were performed to evaluate risk factors.
Among 413 participants, 130 (31.5%) had sub-threshold insomnia on the ISI and 77 (18.64%) exceeded the threshold for clinically significant insomnia. In a multivariate logistic regression model, clinically significant insomnia was independently associated with severe joint pain (adjusted odds ratio, 4.84, 95% confidence interval, 1.71–13.69, P=0.003), mild/moderate hot flashes (AOR, 2.28, 95% CI, 1.13–4.60, P=0.02), severe hot flashes (AOR, 2.29, 95% CI, 1.23–6.81, P=0.015), anxiety (AOR, 1.99, 95% CI, 1.08–3.65, P=0.027), and depression (AOR, 3.57, 95% CI, 1.48–8.52, P=0.004). Age (>65 vs. <55 years, AOR, 2.31, 95% CI, 1.11–4.81, p=0.026), and time since breast cancer diagnosis (<2 years vs. 2–5 years, AOR, 1.94, 95% CI, 1.02–3.69, p=0.045) were also found to be significant risk factors. Clinical insomnia was more common among those who used medication for treating insomnia and pain.
Insomnia complaints exceed 50% among AI users. Clinically significant insomnia is highly associated with joint pain, hot flashes, anxiety and depression, age, and time since diagnosis.
PMCID: PMC3600410  PMID: 22584732
Breast cancer; Insomnia; Aromatase Inhibitors
18.  Prevention and management of adverse events related to regorafenib 
Supportive Care in Cancer  2013;22:837-846.
Regorafenib is an oral multikinase inhibitor that has shown antitumor activity in a range of solid tumors. Based on data from phase III clinical trials, regorafenib is indicated for the treatment of adult patients with metastatic colorectal cancer who have previously been treated with, or are not considered candidates for, other available therapies, and in patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other appropriate treatments. A panel of oncology nurses, research coordinators, and other medical oncology experts, experienced in the care of patients treated with regorafenib, met to discuss the best practice for the management of regorafenib-associated adverse events (AEs). The panel agreed that, in clinical trials and daily practice with regorafenib, AEs are common but mostly manageable. The most common and/or important AEs associated with regorafenib were considered to be hand–foot skin reaction, rash or desquamation, stomatitis, diarrhea, hypertension, liver abnormalities, and fatigue. This manuscript describes the experience and recommendations of the panel for managing these AEs in everyday clinical practice. Appropriate education, monitoring, and management are considered essential for reducing the incidence, duration, and severity of regorafenib-associated AEs.
PMCID: PMC3913844  PMID: 24337717
Regorafenib; Adverse events; Hand–foot skin reaction; Fatigue; Supportive management; Hypertension
20.  Information needs of early-stage prostate cancer patients: within- and between-group agreement of patients and health professionals 
Supportive Care in Cancer  2013;22:999-1007.
The aims of this study were to analyze agreement on information needs within a group of early-state prostate cancer patients and to compare information preferences of patients with the view of health-care professionals about patients’ needs.
Sample consists of patients (n = 128) and six subgroups of health-care professionals (urologists, n = 32; nurses, n = 95; radiotherapy technologists (RTTs), n = 36; medical oncologists, n = 19; radiation oncologists, n = 12; general practitioners (GPs), n = 10). Information needs have been assessed with 92 questions concerning prostate cancer and its treatment. Respondents judged the importance of addressing each question. Within- and between-group agreements of patients and health-care professional groups were estimated with raw agreement indices as well as chance-corrected Kappa and Gwet’s AC1 measures. Finally, group-specific core items rated with high importance as well as high agreement were defined.
Patients rated on average (median) half, i.e., 51 out 92 items as essential (interquartile range (IQR) = 36–66), 26 items as desired (IQR = 14–38), and 10 items as avoidable (IQR = 2–22). Within-group agreement on the presented information topics is modest for any participating group (AC1patients = 0.319; AC1professionals = 0.295–0.398). Agreement between patients and professionals is low too (AC1 = 0.282–0.329). Defining group-specific core sets of information topics results in 51 items being part of at least one core set. Concordance of the item core sets of patients and professionals is moderate with κ = 0.38–0.66, sensitivity of professionals’ core sets for patients’ preferences varies between 56 and 74 %.
Results emphasize the need for dialogue between doctor/professional and patient in identifying the information needed by individual patients and support the importance of shared decision making.
PMCID: PMC3938857  PMID: 24287503
Prostate cancer; Patient information needs; Shared decision making; Patient–physician communication; Health professionals’ opinions
21.  Evaluating the effects of lenalidomide induction therapy on peripheral stem cells collection in patients undergoing autologous stem cell transplant for multiple myeloma 
Lenalidomide (LEN) is a relatively new and very effective therapy for multiple myeloma (MM). Prior LEN therapy is associated with an increased risk of peripheral blood stem cell collection (PBSC) failure, particularly with filgrastim (G-CSF) alone. We performed a retrospective chart review of 319 consecutive MM patients who underwent apheresis to collect PBSCs for the first autologous stem cell transplant (ASCT).
The median number of PBSCs collected in the LEN (+) group was significantly less than the LEN (−) group (6.34 vs. 7.52×106 CD34+ cells/kg; p=0.0004). In addition, the median number of apheresis sessions required for adequate PBSCs collection were significantly more in the LEN (+) group as compared to LEN (−) group (2 vs. 1 sessions; p=0.002). In the LEN (+) group, there was a negative correlation between PBSCs collected and prior number of cycles of LEN (p=0.0001). Rate of PBSC collection failure was 9 % in the LEN (+) group and 5 % in the LEN (−) group (p=0.16). Only six patients who failed PBSC collection with G-CSF were able to collect adequate PBSCs with G-CSF + plerixafor. LEN exposure had no effect on neutrophil or platelet recovery post-ASCT.
Up to four cycles of LEN exposure have minimal negative impact on PBSC collection. Despite prolong exposure of LEN, PBSC collection was adequate for two ASCTs in the majority of patients and post-ASCT engraftment was not longer than expected; however, clinical relevance (complication rate, quality of life, cost) of prolonged LEN exposure on both PBSC and ASCT, should be evaluated in prospective clinical trials.
PMCID: PMC3837683  PMID: 23591714
Lenalidomide; Multiple myeloma; Peripheral stem cells collection
22.  A pilot study to examine patient awareness and provider discussion of the impact of cancer treatment on fertility in a registry-based sample of African American women with breast cancer 
Fertility is a concern for many cancer patients diagnosed during their reproductive years. Although African American women are more likely to be diagnosed with early breast cancer (i.e., ≤age 40), little is known about patient awareness of or provider discussion related to fertility in this group. We examined African American women’s awareness of the possible impact of cancer treatment on fertility.
In a cross-sectional survey of African American women with early-onset breast cancer, demographic and clinical variables were compared with patient awareness and physician discussion of potential fertility loss.
For women in our sample (N=48), 45.8% reported being aware of the potential impact of cancer treatment on fertility, and 56.3% reported that their providers discussed fertility with them. Bivariate analyses demonstrated that awareness was significantly higher in women diagnosed at age ≤45 (p<0.05), who were nulliparous (p<0.01), or who did not have tubal ligation (p<0.001). Provider discussion was more often reported by patients who were diagnosed in stages 2/3 (p<0.05) and had no children (p<0.01).
Study results suggest potential health disparities in reproductive health among early-onset breast cancer patients and demonstrate missed clinical opportunities to provide information about fertility that may impact long-term quality of life in early-onset African American breast cancer patients.
PMCID: PMC3826952  PMID: 22270090
Breast cancer; African American; Cancer registry; Fertility awareness
23.  Functional status and health-related quality of life among allogeneic transplant patients at hospital discharge: a comparison of sociodemographic, disease, and treatment characteristics 
The purpose of this paper is to report the findings of a study of hematopoietic cell transplant patients, describing the needs of allogeneic transplant patients at the time of discharge in regard to their functional status, quality of life (QOL), and caregiver information and comparing these needs across a number of sociodemographic, disease, and treatment characteristics. The findings of this study are part of a larger mixed-methods study, representing one data time point of the larger study.
This paper will discuss the baseline data collected at the time of discharge for 282 allogeneic transplant patients, which include sociodemographic data combined with disease, treatment, functional status, and QOL data to present a comprehensive portrait of the transplant patient at discharge.
Mean age was 48 years, males represented 52%, and 22% of the patients were Hispanic. The majority of the patients had acute leukemia (55%), were diagnosed within the last 3 years, and had matched unrelated (52%) transplants. The time from transplant to discharge averaged 30 days. Mean scores for QOL (scale = 1–10, with 10 = best QOL) included a low score of 5.7 for both psychological and social well-being, 6.3 for overall QOL, and 7.1 for both physical and spiritual well-being. Males had significantly higher QOL than females, as did non-Hispanics. Patients with Hodgkin’s disease had significantly lower overall QOL scores.
Our results highlight the physical, psychological, social, and spiritual challenges which present for patients and their caregivers at the time of hospital discharge following allogeneic transplant.
PMCID: PMC3393810  PMID: 22318502
Allogeneic transplant; Discharge status; Quality of life
24.  Bisphosphonates in the Treatment of Patients with Lung Cancer and Metastatic Bone Disease: A Systematic Review and Meta-analysis 
Bisphosphonates are known to prevent skeletal-related events (SREs) in advanced breast cancer, prostate cancer and multiple myeloma. This systematic review assessed the efficacy of bisphosphonates in preventing SREs, controlling pain, and overall survival in patients with bone metastases from lung cancer.
We searched MEDLINE, EMBASE, Web of Science, and the Cochrane Library databases through November 10, 2011, for controlled trials that included lung cancer patients with bone metastases treated with bisphosphonates. Two reviewers independently extracted data on pain control, survival, SREs and evaluated the quality of each study. Meta-analyses were performed when there were two or more trials with similar outcomes.
Twelve trials, met our inclusion criteria, and included 1,767 patients. Studies were placebo-controlled or compared bisphosphonates with other modalities (chemotherapy, radiation therapy, or radioisotope therapy), or used different bisphosphonates as active controls. Randomized controlled trials did not report adequate descriptions of randomization procedures, allocation concealment, and blinding, resulting in low quality scores. Patients treated with zoledronic acid + chemotherapy had fewer SREs than those receiving chemotherapy alone (relative risk (RR) 0.81, 95% confidence interval (CI) 0.67-0.97). Pain control improved when a bisphosphonate was added to another treatment modality (chemotherapy or radiation; RR 1.18, 95%CI 1.0-1.4). Bisphosphonate therapy improved survival compared to controls, but the difference failed to reach statistical significance (mean of 72 days, 95%CI −8.9-152.9).
Treatment with bisphosphonates reduced SREs, improved pain control and showed a trend to increased survival. Bisphosphonates should be used in the treatment of patients with lung cancer and bone metastases.
PMCID: PMC3691019  PMID: 22956190
Bisphosphonates; Lung cancer/neoplasm; Bone metastases; Randomized controlled trials; Meta-analysis
25.  Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer 
Many women with hormone receptor-positive breast cancer discontinue effective aromatase inhibitor (AI) treatment due to joint symptoms.
We conducted a single-arm, open-label, phase II study evaluating glucosamine-sulfate (1,500 mg/day)+ chondroitin-sulfate (1,200 mg/day) for 24 weeks to treat joint pain/stiffness in postmenopausal women with early stage breast cancer who developed moderate-to-severe joint pain after initiating AIs. The primary endpoint was improvement in pain/stiffness at week 24 assessed by the Outcome Measure in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria. Secondary endpoints assessed changes in pain, stiffness, and function using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index for hips/knees and the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) for hands/wrists. The Brief Pain Inventory (BPI) assessed pain interference, severity, and worst pain.
Of 53 patients enrolled, 39 were evaluable at week 24. From baseline to week 24, 46 % of patients improved according to OMERACT-OARSI criteria. At week 24, there were improvements (all P<0.05) in pain and function as assessed by WOMAC and M-SACRAH, and in pain interference, severity, and worst pain as assessed by BPI. Estradiol levels did not change from baseline. The most commonly reported side effects were headache (28 %), dyspepsia (15 %), and nausea (17 %).
In this single-arm study, 24 weeks of glucosamine/chondroitin resulted in moderate improvements in AI-induced arthralgias, with minimal side effects, and no changes in estradiol levels. These results suggest a need to evaluate efficacy in a placebo-controlled trial.
PMCID: PMC3810608  PMID: 23111941
Breast cancer; Aromatase inhibitors; Arthralgias; Dietary supplement; Glucosamine; Chondroitin

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