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1.  Spiritual Well-Being and Depressive Symptoms among Cancer Survivors 
Purpose
Depression is common among patients diagnosed with cancer and may be inversely associated with spiritual well-being. While numerous strategies are employed to manage and cope with illness, spiritual well-being has become increasingly important in cancer survivorship research. This study examined the association between spiritual well-being and depressive symptoms.
Methods
This cross-sectional study utilized self-report data from 102 diverse cancer survivors recruited from peer-based cancer support groups in San Diego County. Depression was measured with the Patient Health Questionnaire-8 (PHQ-8) and spiritual well-being was measured with the Functional Assessment of Chronic Illness Therapy--Spiritual Well-being (FACIT-Sp) comprised of two subscales (Meaning/Peace and Faith).
Results
Hierarchal regression analysis indicated that Meaning/Peace significantly predicted depressive symptoms after adjusting for socio-demographics, cancer stage, time since diagnosis, and Faith (p < .001).
Conclusions
Findings suggest that spiritual well-being is a valuable coping mechanism and that Meaning/Peace has a unique advantage over Faith in protecting cancer survivors from the effects of depression symptoms; therefore, turning to Meaning/Peace as source of strength may improve psychological well-being during survivorship.
Implications
Future programs and healthcare providers should be cognizant of the influential role of spiritual well-being in depression symptoms in an effort to improve psychological well-being among cancer survivors.
doi:10.1007/s00520-014-2207-2
PMCID: PMC4324591  PMID: 24691887
cancer; depression; spiritual well-being; coping style; survivorship
2.  [No title available] 
PMCID: PMC3947298  PMID: 24101152
3.  [No title available] 
PMCID: PMC3947315  PMID: 24091722
4.  [No title available] 
PMCID: PMC3947331  PMID: 24091718
5.  Performance of the Family Satisfaction with the End-of-Life Care (FAMCARE) measure in an ethnically diverse cohort: Psychometric analyses using item response theory 
The Family Satisfaction with End-of-Life Care (FAMCARE) has been used widely among caregivers to individuals with cancer. The aim of this study was to evaluate the psychometric properties of this measure using item response theory (IRT).
Methods
The analytic sample was comprised of caregivers to 1983 patients with advanced cancer. Among the patients, 56% were female, with mean age 59.9 (s.d. = 11.8); 20% were non-Hispanic Black. The majority were family members either living with (44%) or not living with (35%) the patient.
Factor analyses and IRT were used to examine the dimensionality, information and reliability of the FAMCARE.
Results
Although a bi-factor model fit the data slightly better than did a unidimensional model, the loadings on the group factors were very low. Thus, a unidimensional model appears to provide adequate representation for the item set. The reliability estimates, calculated along the satisfaction (theta) continuum were adequate (>0.80) for all levels of theta for which subjects had scores.
Examination of the category response functions from IRT showed overlap in the lower categories with little unique information provided; moreover the categories were not observed to be interval. Based on these analyses, a three response category format was recommended: very satisfied, satisfied and not satisfied. Most information was provided in the range indicative of either dissatisfaction or high satisfaction.
Conclusions
These analyses support the use of fewer response categories, and provide item parameters that form a basis for developing shorter-form scales. Such a revision has the potential to reduce respondent burden.
doi:10.1007/s00520-013-1988-z
PMCID: PMC4151612  PMID: 24091717
FAMCARE; patient; caregiver; satisfaction; item response theory; psychometric properties
6.  A Literature Synthesis of Symptom Prevalence and Severity in Persons Receiving Active Cancer Treatment 
Purpose
Patients with cancer experience acute and chronic symptoms caused by their underlying disease or by the treatment. While numerous studies have examined the impact of various treatments on symptoms experienced by cancer patients, there are inconsistencies regarding the symptoms measured and reported in treatment trials. This article presents a systematic review of the research literature of the prevalence and severity of symptoms in patients undergoing cancer treatment.
Methods
A systematic search for studies of persons receiving active cancer treatment was performed with the search terms of “multiple symptoms” and “cancer” for studies involving patients over the age of 18 years and published in English during the years 2001 to 2011. Search outputs were reviewed independently by seven authors, resulting in the synthesis of 21 studies meeting criteria for generation of an Evidence Table reporting symptom prevalence and severity ratings.
Results
Data were extracted from 21 multi-national studies to develop a pooled sample of 4067 cancer patients in whom the prevalence and severity of individual symptoms was reported. In total, the pooled sample across the 21 studies was comprised of 62% female, with a mean age of 58 years (range: 18 to 97 years). A majority (62%) of these studies assessed symptoms in homogeneous samples with respect to tumor site (predominantly breast and lung cancer), while 38% of the included studies utilized samples with mixed diagnoses and treatment regimens. Eighteen instruments and structured interviews were including those measuring single symptoms, multi-symptom inventories, and single symptom items drawn from HRQOL or health status measures. The MD Anderson Symptom Inventory (MDASI) was the most commonly used instrument in the studies analyzed (n=9 studies; 43%), while the Functional Assessment of Cancer Therapy (FACT-G), Hospital Anxiety and Depression Subscale (HADS-D), Medical Outcomes Survey Short Form-36 (SF-36), and Symptom Distress Scale (SDS) were each employed in two studies. Forty-seven symptoms were identified across the 21 studies which were then categorized into 17 logical groupings. Symptom prevalence and severity were calculated across the entire cohort and also based upon sample sizes in which the symptoms were measured providing the ability to rank symptoms.
Conclusions
Symptoms are prevalent and severe among patients with cancer. Therefore, any clinical study seeking to evaluate the impact of treatment on patients should consider including measurement of symptoms. This study demonstrates that a discrete set of symptoms is common across cancer types. This set may serve as the basis for defining a “core” set of symptoms to be recommended for elicitation across cancer clinical trials, particularly among patients with advanced disease.
doi:10.1007/s00520-012-1688-0
PMCID: PMC4299699  PMID: 23314601
Cancer; symptoms; systematic review
7.  Impact of symptom burden in post-surgical non-small cell lung cancer survivors 
Purpose
Pain, fatigue, dyspnea, and distress are commonly reported cancer-related symptoms, but few studies have examined the effects of multiple concurrent symptoms in longer-term cancer survivors. We examined the impact of varying degrees of symptom burden on health-related quality of life (HRQOL) and performance status in surgically treated non-small cell lung cancer (NSCLC) survivors.
Methods
A sample of 183 NSCLC survivors 1–6 years post-surgical treatment completed questionnaires assessing five specific symptoms (pain, fatigue, dyspnea, depression, and anxiety), HRQOL, and performance status. The number of concurrent clinically significant symptoms was calculated as an indicator of symptom burden.
Results
Most survivors (79.8 %) had some degree of symptom burden, with 30.6 % reporting one clinically significant symptom, 27.9 % reporting two symptoms, and 21.3 % reporting three or more symptoms. Physical HRQOL significantly decreased as the degree of symptom burden increased, but mental HRQOL was only significantly decreased in those with three or more symptoms. Receiver-operating characteristic (ROC) curves showed that having multiple concurrent symptoms (two or more) was most likely associated with limitations in functioning (area under a ROC curve=0.75, sensitivity=0.81, specificity=0.54).
Conclusions
Two or more clinically significant symptoms are identified as the “tipping point” for showing adverse effects on HRQOL and functioning. This highlights the need for incorporating multiple-symptom assessment into routine clinical practice. Comprehensive symptom management remains an important target of intervention for improved post-treatment HRQOL and functioning among lung cancer survivors.
doi:10.1007/s00520-013-1968-3
PMCID: PMC3971862  PMID: 24018910
Lung cancer survivor; Symptom burden; Quality of life; Pain; Depression; Anxiety
8.  Bone Health Issues in Breast Cancer Survivors: A Medicare Current Beneficiary Survey (MCBS) Study 
Purpose
Breast cancer treatments (chemotherapy and hormone therapy) can cause a rapid loss in bone mineral density, leading to osteoporosis and fractures later in life. Fortunately, preventative measures (vitamin D, exercise, etc.) can delay bone loss if employed early enough. This study compares the prevalence of osteoporosis and osteoporosis-related discussions with physicians among female breast cancer survivors and females with no cancer history to determine if breast cancer patients are being correctly advised on their high risk of bone loss.
Methods
The 2003 Medicare Current Beneficiary Survey, a nationally representative sample of 550 women with a breast cancer history and 6,673 women with no cancer history aged ≥65, was used. The first set of dependent variables collected information on bone health (osteoporosis, falls, and fractures). The second set of dependent variables collected information on bone health discussions with their physician. Multivariate logistic regression models were used to evaluate whether breast cancer was independently associated with bone health issues.
Results
After adjustment for confounders, a breast cancer diagnosis was found to be associated with a higher prevalence of an osteoporosis diagnosis over their lifetime (adjusted odds ratio [ORadj] = 1.32, 95% confidence interval [95%CI]=1.08-1.61) and falls in the previous year (ORadj=1.23, 95%CI=1.01-1.51) compared to respondents without a cancer diagnosis. However, breast cancer respondents were not more likely than respondents without a cancer diagnosis to discuss osteoporosis with their physician (ORadj=1.20, 95%CI=0.96-1.50) or be told they are at high risk for osteoporosis (ORadj=1.41, 95%CI=0.95-2.10).
Conclusions
A breast cancer diagnosis was associated with an increased prevalence of osteoporosis and falls. Nevertheless, breast cancer respondents were not more likely to discuss osteoporosis with their physician nor were they more likely to be considered high risk for osteoporosis. Increased dialogue between physician and breast cancer patient pertaining to bone loss are needed.
doi:10.1007/s00520-013-1967-4
PMCID: PMC4049181  PMID: 24043289
9.  Prescription and Adherence to Lymphedema Self-Care Modalities among Women with Breast Cancer-Related Lymphedema 
Purpose
To profile the prescription for and adherence to breast cancer related lymphedema (BCRL) self-care modalities among breast cancer (BrCa) survivors with BCRL in a 12-month randomized weightlifting trial.
Methods
We developed a questionnaire that assessed prescription for and adherence to 10 BCRL self-care modalities that included physical therapy exercise, pneumatic compression pump, medication, lymphedema bandaging, arm elevation, self-administered lymphatic drainage, therapist-administered lymphatic drainage, compression garments, skin care, and taping. We measured prescription for and adherence to BCRL self-care modalities at baseline, 3-, 6-, and 12-months. Longitudinal logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (95% CI) associated with prescription for and adherence to BCRL modalities over time.
Results
This study included 141 BrCa survivors with BCRL. Women were prescribed an average of 3.6±2.1 BCRL self-care modalities during the study. The prescription of therapistadministered lymphatic drainage (OR=0.92, 95% CI: 0.88–0.96), pneumatic compression pump use (OR=0.94, 95% CI: 0.89–0.98), and bandaging (OR=0.96, 95% CI: 0.93–0.99) decreased over 12-months of follow-up. No other prescribed BCRL self-care modalities changed during the study. Over 12-months, the average adherence to all BCRL self-care modalities varied with 13%, 24%, 32%, and 31% of women reporting <25%, 25–49%, 50–74%, and ≥75% adherence, respectively. Over 12-months, there was a noticeable change from high to low adherence in self-administered lymphatic drainage, such that there was a 15% increased likelihood of adherence <25% compared to ≥75% (OR=1.15 (95% CI: 1.05–1.26); p=0.002). The adherence patterns of all other modalities did not change over follow-up.
Conclusions
Our findings suggest the prescription of BCRL self-care modalities is variable. The average adherence to BCRL self-care was non-optimal. Future research is necessary to prepare BrCa survivors with the knowledge, skills, abilities, and resources necessary to care for this lifelong condition.
doi:10.1007/s00520-013-1962-9
PMCID: PMC4122426  PMID: 24013569
compression; self-care; compliance; management; quality-of-life
10.  Factors Predicting Adherence to Risk Management Behaviors of Women at Increased Risk for Developing Lymphedema 
Purpose
Lymphedema affects 20-30% of women following breast cancer treatment. However, even when women are informed, they do not necessarily adhere to recommended lymphedema self-management regimens. Utilizing the Cognitive-Social Health Information Processing framework, we assessed cognitive and emotional factors influencing adherence to lymphedema risk management.
Methods
Women with breast cancer who had undergone breast and lymph node surgery were recruited through the Fox Chase Cancer Centre breast clinic. Participants (N=103) completed measures of lymphedema-related perceived risk, beliefs and expectancies, distress, self-regulatory ability to manage distress, knowledge, and adherence to risk management behaviors. They then received the American Cancer Society publication “Lymphedema: What Every Woman with Breast Cancer Should Know”. Cognitive and affective variables were reassessed at 6- and 12-months post-baseline.
Results
Maximum likelihood multilevel model analyses indicated that overall adherence increased over time, with significant differences between baseline and 6- and 12- month assessments. Adherence to wearing gloves was significantly lower than that for all other behaviors except electric razor use. Distress significantly decreased, and knowledge significantly increased, over time. Greater knowledge, higher self-efficacy to enact behaviors, lower distress, and higher self-regulatory ability to manage distress were associated with increased adherence.
Conclusions
Women who understand lymphedema risk management and feel confident in managing this risk are more likely to adhere to recommended strategies. These factors should be rigorously assessed as part of routine care to ensure that women have the self-efficacy to seek treatment and the self-regulatory skills to manage distress, which may undermine attempts to seek medical assistance.
doi:10.1007/s00520-014-2321-1
PMCID: PMC4270823  PMID: 24970542
breast cancer; lymphedema; cognitive; affective; adherence; self-care
11.  Incidence of infusion-site reactions associated with peripheral intravenous administration of fosaprepitant 
Purpose
Fosaprepitant is known to cause infusion-site reactions. However, there is limited data regarding these reactions including the effect of peripheral intravenous administration or other potential factors on their incidence. This single-institution retrospective study was undertaken to investigate the incidence of infusion-site reactions with single-dose intravenous (IV) fosaprepitant when given through a peripheral line prior to administration of chemotherapy. Risk factors for the development of infusion-site reactions with fosaprepitant were also explored.
Methods
Medical records of patients with cancer receiving IV fosaprepitant through a peripheral line were reviewed. The primary objective of this study was to estimate the incidence of infusion-site reactions at our institution. Data collection included demographics, fosaprepitant infusion information, and grading of reactions.
Results
We found a 15 % incidence of infusion-site reactions among all peripherally administered doses of fosaprepitant. The 50 reactions occurred in 43 unique patients representing an incidence per patient of 28.7 % (43/150; 95 % confidence interval (CI) 21.6–36.6). Factors found to be associated with infusion-site reactions included age [odds ratio (OR) 0.97 (95 % CI 0.94–0.99)], location of IV line [OR forearm vs. hand 0.41 (95% CI 0.20–0.85); OR antecubital fossa vs. hand 0.31 (95 % CI 0.11–0.87)], and simultaneous maintenance IV fluid rate ≥100 mL/h during fosaprepitant infusion [OR 0.19 (95 % CI 0.08–0.44)].
Conclusions
The incidence of infusion-site reactions with peripherally administered fosaprepitant as seen in this study is higher than that reported in the package insert. Risk factors for developing infusion-site reactions in our patient population include age, location of IV line, and simultaneous maintenance IV fluid rate of <100 mL/h.
doi:10.1007/s00520-013-2106-y
PMCID: PMC4277851  PMID: 24402412
Fosaprepitant; Infusion-site reactions; Peripheral intravenous administration
12.  “I know it when I see it.” The complexities of measuring resilience among parents of children with cancer 
Purpose
Promoting parent resilience may provide an opportunity to improve family-level survivorship after pediatric cancer; however, measuring resilience is challenging.
Methods
The “Understanding Resilience in Parents of Children with Cancer” was a cross-sectional, mixed-methods study of bereaved and non-bereaved parents. Surveys included the Connor-Davidson Resilience scale, the Kessler-6 psychological distress scale, the Post-Traumatic Growth Inventory, and an open-ended question regarding the on-going impact of cancer. We conducted content analyses of open-ended responses and categorized our impressions as “resilient,” “not resilient,” or “unable to determine.” “Resilience” was determined based on evidence of psychological growth, lack of distress, and parent-reported meaning/purpose. We compared consensus-impressions with instrument scores to examine alignment. Analyses were stratified by bereavement status.
Results
Eighty-four (88%) non-bereaved, and 21 (88%) bereaved parents provided written responses. Among non-bereaved, 53 (63%) were considered resilient, 15 (18%) were not. Among bereaved, 11 (52%) were deemed resilient, 5 (24%) were not. All others suggested a mixed or incomplete picture. Rater-determined “resilient” parents tended to have higher personal resources and lower psychological distress (p=<0.001–0.01). Non-bereaved “resilient” parents also had higher post-traumatic growth (p=0.02). Person-level analyses demonstrated that only 50–62% of parents had all 3 instrument scores aligned with our impressions of resilience.
Conclusions
Despite multiple theories, measuring resilience is challenging. Our clinical impressions of resilience were aligned in 100% of cases; however, instruments measuring potential markers of resilience were aligned in approximately half. Promoting resilience therefore requires understanding of multiple factors, including person-level perspectives, individual resources, processes of adaptation and emotional well-being.
doi:10.1007/s00520-014-2249-5
PMCID: PMC4264630  PMID: 24756554
Cancer; Oncology; Pediatrics; Parents; Resilience; Psychosocial Outcomes
13.  Treatment Regret and Quality of Life Following Radical Prostatectomy 
Purpose
Negative physical functioning outcomes including incontinence and erectile dysfunction are relatively common following radical prostatectomy (RP) and are associated with treatment regret and compromised quality of life (QOL). The role that treatment regret may have in influencing the association between prostate-specific QOL (i.e., sexual, urinary, bowl functioning) and general QOL following RP has not been examined.
Method
This study examined the associations of treatment regret, general QOL (SF-36 Physical (PCS) and Mental Health (MCS) composite scores) and prostate-specific QOL (PCQOL sexual, urinary, bowl functioning, and cancer worry subscales) in 95 men who underwent RP for prostate cancer.
Results
Multiple regression analyses indicated that poorer sexual and urinary functioning was associated with poorer MCS. Additionally, men with lower sexual and urinary functioning reported greater treatment regret. Treatment regret was also associated with lower MCS. Finally, treatment regret partially mediated the effects of both sexual and urinary functioning on MCS.
Conclusions
These findings suggest that regardless of a patient’s prostate-specific QOL, reducing treatment regret may improve mental health following RP. Though there are limited options to alter patients’ sexual or urinary functioning following RP, treatment regret may be a modifiable contributor to post-surgical adjustment and QOL.
doi:10.1007/s00520-013-1906-4
PMCID: PMC3823814  PMID: 23907238
treatment regret; prostate cancer; psychosocial adjustment; QOL
14.  Does it Matter What You Call It? A Randomized Trial of Language Used to Describe Palliative Care Services 
Purpose
Integration of palliative care into oncology practice remains suboptimal. Misperceptions about the meaning of palliative care may negatively impact utilization. We assessed whether the term and/or the description of palliative care services affected patient views.
Methods
2×2 between-subject randomized factorial telephone survey of 169 patients with advanced cancer. Patients were randomized into 1 of 4 groups that differed by name (supportive care vs. palliative care) and description (patient-centered vs. traditional). Main outcomes (0–10 Likert scale) were patient understanding, impressions, perceived need, and intended use of services.
Results
When compared to palliative care, the term supportive care was associated with better understanding (7.7 vs. 6.8; p=0.021), more favorable impressions (8.4 vs. 7.3; p=0.002), and higher future perceived need (8.6 vs. 7.7; p=0.017). There was no difference in outcomes between traditional and patient-centered descriptions. In adjusted linear regression models, the term supportive care remained associated with more favorable impressions (p=0.003) and higher future perceived need (p=0.022) when compared to palliative care.
Conclusions
Patients with advanced cancer view the name supportive care more favorably than palliative care. Future efforts to integrate principles of palliative medicine into oncology may require changing impressions of palliative care or substituting the term supportive care.
doi:10.1007/s00520-013-1919-z
PMCID: PMC3823760  PMID: 23942596
Palliative Care; Supportive Care; Advanced Cancer; Communication; Oncology
15.  Perceptions, Expectations, and Attitudes about Communication with Physicians among Chinese American and non-Hispanic White Women with Early-Stage Breast Cancer 
Purpose
Asian Americans have consistently reported poorer communication with physicians compared with non-Hispanic Whites (NHW). This qualitative study sought to elucidate the similarities and differences in communication with physicians between Chinese and NHW breast cancer survivors.
Methods
Forty-four Chinese and 28 NHW women with early-stage breast cancer (stage 0-IIa) from the Greater Bay Area Cancer Registry participated in focus group discussions or individual interviews. We oversampled Chinese women because little is known about their cancer care experiences. In both interview formats, questions explored patients’ experiences and feelings when communicating with physicians about their diagnosis, treatment, and follow-up care.
Results
Physician empathy at the time of diagnosis was important to both ethnic groups; however, during treatment and follow-up care, physicians’ ability to treat cancer and alleviate physical symptoms was a higher priority. NHW and US-born Chinese survivors were more likely to assert their needs, whereas Chinese immigrants accepted physician advice even when it did not alleviate physical problems (e.g., pain). Patients viewed all physicians as the primary source for information about cancer care. Many Chinese immigrants sought additional information from primary care physicians and stressed optimal communication over language concordance.
Conclusions
Physician empathy and precise information were important for cancer patients. Cultural differences such as the Western emphasis on individual autonomy vs. Chinese emphasis on respect and hierarchy can be the basis for the varied approaches to physician communication we observed. Interventions based on cultural understanding can foster more effective communication between immigrant patients and physicians ultimately improving patient outcomes.
doi:10.1007/s00520-013-1902-8
PMCID: PMC4018227  PMID: 23903797
Patient-Physician communication; Chinese Americans; Culture; Breast Cancer
16.  Symptom Clusters of Pain, Depressed Mood, and Fatigue in Lung Cancer: Assessing the Role of Cytokine Genes 
PURPOSE
Symptom clusters, the multiple, co-occurring symptoms experienced by cancer patients, are debilitating and affects quality of life. We assessed if a panel of immune-response genes may underlie the co-occurrence of severe pain, depressed mood and fatigue and help identify patients with severe versus non-severe symptom clusters.
METHODS
Symptoms were assessed at presentation, prior to cancer treatment in 599 newly diagnosed lung cancer patients. We applied cluster analyses to determine the patients with severe versus non-severe symptom clusters of pain, depressed mood, and fatigue.
RESULTS
Two homogenous clusters were identified. One hundred sixteen patients (19%) comprised the severe symptom cluster, reporting high intensity of pain, depressed mood and fatigue and 183 (30%) patients reported low intensity of these symptoms. Using Bayesian model averaging methodology, we found that of the 55 SNPs assessed, an additive effect of mutant alleles in ENOS (-1474 T/A) (Posterior Probability of Inclusion (PPI) = 0.78, OR = 0.54, 95% CI = (0.31, 0.93); IL1B T-31C (PPI = 0.72, OR = 0.55, 95% CI = (0.31, 0.97)); TNFR2 Met196Arg (PPI = 0.70; OR=1.85;95%CI=(1.03,3.36)); PTGS2 exon 10+837T>C (PPI = 0.69, OR = 0.54, 95%CI = (0.28, 0.99)); and IL10RB Lys47Glu (PPI = 0.68; OR=1.74; 95%CI=(1.04,2.92)) were predictive for symptom clusters.
CONCLUSIONS
Genetic polymorphisms may facilitate identification of high risk patients and development of individualized symptom therapies.
doi:10.1007/s00520-013-1885-5
PMCID: PMC3923575  PMID: 23852407
pain; depression; fatigue; cytokines; symptoms; genes; epidemiology; lung cancer; SNPs
17.  Assessment of Long-Term Rectal Function in Patients Who Received Pelvic Radiotherapy: A Pooled North Central Cancer Treatment Group Trial Analysis, N09C1 
Purpose
Pelvic radiotherapy (PRT) is known to adversely affect bowel function (BF) and patient well-being. This study characterized long-term BF and evaluated quality of life (QOL) in patients receiving PRT.
Methods
Data from 252 patients were compiled from 2 North Central Cancer Treatment Group prospective studies, which included assessment of BF and QOL by the BF questionnaire (BFQ) and Uniscale QOL at baseline and 12 and 24 months after completion of radiotherapy. BFQ scores (sum of symptoms), Uniscale results, adverse-event incidence, and baseline demographic data were compared via t test, χ2, Fisher exact, Wilcoxon, and correlation methodologies.
Results
The total BFQ score was higher than baseline at 12 and 24 months (P<.001). More patients had 5 or more symptoms at 12 months (13%) and 24 months (10%) than at baseline (2%). Symptoms occurring in greater than 20% of patients at 12 and 24 months were clustering, stool-gas confusion, and urgency. Factors associated with worse BF were female sex, rectal or gynecologic primary tumors, prior anterior resection of the rectum, and 5-fluorouracil chemotherapy. Patients experiencing grade 2 or higher acute toxicity had worse 24-month BF (P values, <.001-.02). Uniscale QOL was not significantly different from baseline at 12 or 24 months, despite worse BFQ scores.
Conclusions
PRT was associated with worse long-term BF. Worse BFQ score was not associated with poorer QOL. Further research to characterize the subset of patients at risk of significant decline in BF is warranted.
doi:10.1007/s00520-013-1853-0
PMCID: PMC3769434  PMID: 23748483
adverse events; diarrhea; large intestine; quality of life; rectum; toxicity
18.  Characterization of the Yoshida Sarcoma: A Model of Cancer Cachexia 
Purpose
Cancer cachexia contributes significantly to morbidity and mortality in individuals with cancer. Currently, the mechanisms contributing to the development of cachexia are largely unknown, leading to a paucity of treatment and prevention options. Animal models are necessary in determining causal mechanisms and in testing potential treatments. While the Yoshida sarcoma has been utilized for 50 more than years, the cachexia syndrome produced by this model has not been well characterized in the literature.
Methods
Tumor allografts were subcutaneously implanted in male Sprague Dawley rats (n = 16), and allowed to grow for 23 days. Control animals (n = 16) received a sham surgery. All rats were monitored daily for the presence of hallmark cachexia symptoms.
Results
The present results demonstrate the presence of decreased body weight gain, as well as lower levels of body adiposity and skeletal muscle mass, in tumor-bearing animals, as compared to controls.
Conclusions
While a large tumor burden was reached, the extent of cachexia was similar to that which is observed in many individuals with cancer cachexia. Future experiments utilizing this model are encouraged to identify mechanisms and effective treatment and prevention strategies.
doi:10.1007/s00520-013-1839-y
PMCID: PMC3780404  PMID: 23689977
cancer cachexia; animals models; Yoshida sarcoma
19.  Oral and dental late effects in survivors of childhood cancer: a Children’s Oncology Group report 
Purpose
Multi-modality therapy has resulted in improved survival for childhood malignancies. The Children’s Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers provide practitioners with exposure- and risk-based recommendations for the surveillance and management of asymptomatic survivors who are at least 2 years from completion of therapy. This review outlines the pathophysiology and risks for oral and dental late effects in pediatric cancer survivors and the rationale for oral and dental screening recommended by the Children’s Oncology Group.
Methods
An English literature search for oral and dental complications of childhood cancer treatment was undertaken via MEDLINE and encompassed January 1975 to January 2013. Proposed guideline content based on the literature review was approved by a multi-disciplinary panel of survivorship experts and scored according to a modified version of the National Comprehensive Cancer Network “Categories of Consensus” system.
Results
The Children’s Oncology Group oral-dental pan el selected 85 relevant citations. Childhood cancer therapy may impact tooth development, salivary function, craniofacial development, and temporomandibular joint function placing some childhood cancer survivors at an increased risk for poor oral and dental health. Addition ally, head and neck radiation and hematopoietic stem cell transplantation increase the risk of subsequent ma lignant neoplasms in the oral cavity. Survivors require routine dental care to evaluate for potential side effects and initiate early treatment.
Conclusions
Certain childhood cancer survivors are at an increased risk for poor oral and dental health. Early identification of oral and dental morbidity and early interventions can optimize health and quality of life.
doi:10.1007/s00520-014-2260-x
PMCID: PMC4118932  PMID: 24781353
Pediatric cancer; Oral dental health; Survivorship; Late effects
20.  The relationship between weight loss and health-related quality of life in persons treated for head and neck cancer 
Purpose
This study explores the relationship between weight loss, health-related quality of life (HRQOL), and symptom burden in patients treated for head and neck cancers.
Methods
Participants completed the Functional Assessment of Cancer Therapy—Head and Neck (FACT-H&N) and the Memorial Symptom Assessment Scale (MSAS) pre-treatment, mid-treatment, and post-treatment. Weights were recorded prior to treatment and at the post-treatment follow-up visit, and percentage weight loss was tabulated. Relationships between weight loss, HRQOL, and symptom burden were evaluated using the nonparametric Spearman rho. A simple linear regression model was developed to examine the influence weight loss has on HRQOL in a predictive manner.
Results
Average weight loss per patient was 12 lb with a modal value of 19. Weight loss was found to be significantly correlated with decreases in physical well-being, functional well-being, the Head and Neck specific subscale, and composite QOL scores. No significant correlations were found between weight loss and symptom burden as measured by the MSAS. Linear regression suggested that a 10% decrease in baseline weight resulted in a 19% decrease in the FACT-H&N score.
Conclusion
The strong association between weight loss and HRQOL supports the importance of efforts to prevent weight loss via patient education, aggressive monitoring, and immediate intervention to stop or reverse weight loss during treatment. New approaches to the weight loss and wasting experienced by patients should be developed and tested.
doi:10.1007/s00520-010-0975-x
PMCID: PMC4177674  PMID: 20730547
Weight loss; Quality of life; Head and neck cancer; Symptom burden; Nutrition
21.  Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain 
Supportive Care in Cancer  2014;23:823-830.
Aim
To evaluate the long-term safety and efficacy of prolonged-release oxycodone/naloxone (OXN PR) and its impact on quality of life (QoL), in patients with moderate-to-severe cancer pain.
Methods
This was an open-label extension (OLE) of a 4 week, randomized, double-blind (DB) study in which patients with moderate-to-severe cancer pain had been randomized to OXN PR or oxycodone PR (OxyPR). During the OLE phase, patients were treated with OXN PR capsules (≤20/60 mg/day) for ≤24 weeks. Outcome measures included safety, efficacy and QoL.
Results
One hundred and twenty-eight patients entered the OLE, average pain scores based on the modified Brief Pain Inventory—Short Form were low and stable over the 24-week period. The improvement in bowel function and constipation symptoms as measured by the Bowel Function Index and patient assessment of constipation in patients treated with OXN PR during the 4-week DB study was maintained. In patients treated with OxyPR during the DB phase, bowel function and constipation symptoms were improved during the OLE. In the DB and in the OLE, health status and QoL were similar for patients treated with OXN PR and OxyPR. There were no unexpected safety or tolerability issues.
Conclusions
In patients with moderate-to-severe cancer pain, long-term use of OXN PR is well tolerated and effective, resulting in sustained analgesia, improved bowel function and improved symptoms of constipation.
doi:10.1007/s00520-014-2435-5
PMCID: PMC4311064  PMID: 25218610
Oxycodone; Naloxone; Opioid-induced constipation; Analgesia; Bowel function
22.  Breast Cancer Survivors Willingness to Participate in an Acupuncture Clinical Trial: A Qualitative Study 
Purpose
Acupuncture is a complementary and alternative medicine (CAM) modality that shows promise as a component of supportive breast cancer care. Lack of robust recruitment for clinical trial entry has limited the evidence-base for acupuncture as a treatment modality among breast cancer survivors. The objective of this study is to identify key decision making factors among breast cancer survivors considering entry into an acupuncture clinical trial for treatment of symptoms.
Methods
Semi-structured interviews were conducted among African-American (n=12) and Caucasian (n=13) breast cancer survivors. Verbatim transcripts were made and analyzed by two or more independent coders using NVivo software. Major recurring themes were identified and a theoretical framework developed.
Results
Six themes emerged reflecting key attributes of the decision to enter a clinical trial: 1) symptom appraisal, 2) practical barriers (e.g. distance, travel), 3) beliefs about the interventions (e.g. fear of needles, dislike of medications), 4) comfort with elements of clinical trial design (e.g., randomization, the nature of the control intervention, and blinding), 5) trust, and 6) altruism. African-American and Caucasian women weighed similar attributes but differed in the information sources sought regarding clinical trial entry and in concerns regarding the use of a placebo in a clinical trial.
Conclusions
We present of a theoretical framework of decision making for breast cancer survivors considering entry into a CAM clinical trial for symptom management. This framework can inform both research studies and programmatic initiatives to support a shared decision making process and robust recruitment to CAM trials among cancer survivors.
doi:10.1007/s00520-013-2073-3
PMCID: PMC4162629  PMID: 24362843
Breast Cancer Survivors; Acupuncture; Clinical Trials; Decision Making
23.  Basic oral care for hematology–oncology patients and hematopoietic stem cell transplantation recipients: a position paper from the joint task force of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) and the European Society for Blood and Marrow Transplantation (EBMT) 
Supportive Care in Cancer  2014;23(1):223-236.
Purpose
Hematology–oncology patients undergoing chemotherapy and hematopoietic stem cell transplantation (HSCT) recipients are at risk for oral complications which may cause significant morbidity and a potential risk of mortality. This emphasizes the importance of basic oral care prior to, during and following chemotherapy/HSCT. While scientific evidence is available to support some of the clinical practices used to manage the oral complications, expert opinion is needed to shape the current optimal protocols.
Methods
This position paper was developed by members of the Oral Care Study Group, Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) and the European Society for Blood and Marrow Transplantation (EBMT) in attempt to provide guidance to the health care providers managing these patient populations.
Results
The protocol on basic oral care outlined in this position paper is presented based on the following principles: prevention of infections, pain control, maintaining oral function, the interplay with managing oral complications of cancer treatment and improving quality of life.
Conclusion
Using these fundamental elements, we developed a protocol to assist the health care provider and present a practical approach for basic oral care. Research is warranted to provide robust scientific evidence and to enhance this clinical protocol.
doi:10.1007/s00520-014-2378-x
PMCID: PMC4328129  PMID: 25189149
Oral; Dental; Hygiene; Hematology; Hematopoietic stem cell transplantation; Cancer
24.  Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial 
Supportive Care in Cancer  2014;23:723-732.
Purpose
Subcutaneous APF530 provides controlled sustained release of granisetron to prevent acute (0–24 h) and delayed (24–120 h) chemotherapy-induced nausea and vomiting (CINV). This randomized, double-blind phase 3 trial compared APF530 and palonosetron in preventing acute and delayed CINV after moderately (MEC) or highly emetogenic chemotherapy (HEC).
Methods
Patients receiving single-day MEC or HEC received single-dose APF530 250 or 500 mg subcutaneously (SC) (granisetron 5 or 10 mg) or intravenous palonosetron 0.25 mg. Primary objectives were to establish APF530 noninferiority to palonosetron for preventing acute CINV following MEC or HEC and delayed CINV following MEC and to determine APF530 superiority to palonosetron for preventing delayed CINV following HEC. The primary efficacy end point was complete response (CR [using CI difference for APF530 − palonosetron]). A lower confidence bound greater than −15 % indicated noninferiority.
Results
In the modified intent-to-treat population (MEC = 634; HEC = 707), both APF530 doses were noninferior to palonosetron in preventing acute CINV after MEC (CRs 74.8 % [−9.8, 9.3] and 76.9 % [−7.5, 11.4], respectively, vs. 75.0 % palonosetron) and after HEC (CRs 77.7 % [−11.5, 5.5] and 81.3 % [-7.7, 8.7], respectively, vs. 80.7 % palonosetron). APF530 500 mg was noninferior to palonosetron in preventing delayed CINV after MEC (CR 58.5 % [−9.5, 12.1] vs. 57.2 % palonosetron) but not superior in preventing delayed CINV after HEC. Adverse events were generally mild and unrelated to treatment, the most common (excluding injection-site reactions) being constipation.
Conclusions
A single subcutaneous APF530 injection offers a convenient alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC.
doi:10.1007/s00520-014-2400-3
PMCID: PMC4311069  PMID: 25179689
Cancer; Chemotherapy-induced nausea and vomiting (CINV); Extended-release; Granisetron; Subcutaneous; APF530
25.  Distress among young adult cancer survivors: a cohort study 
Purpose
Being diagnosed with cancer as a young adult can lead to significant psychological distress and impaired quality of life. Compared to children and older adults diagnosed with cancer, fewer studies have addressed psychological distress among young adult cancer survivors. This study sought to identify the prevalence of, and factors associated with, distress among young adult cancer survivors (ages 18–39).
Methods
Young adult cancer survivors (N=335, mean age= 31.8, women=68.4 %) were recruited from an online research panel and stratified by cohort (time postactive treatment: 0–12, 13–24, and 25–60 months). Participants completed measures assessing demographic and clinical characteristics, global impact of cancer, cancer-related education and work interruption, and cancer-specific distress using the impact of event scale (IES).
Results
The mean score on the IES (M=31.0, range=0–75) was above the cut point of 20, suggesting clinically elevated distress. Analysis of covariance revealed significant main effects for cohort, global impact and cancer-related education/work interruption, and an interaction between cohort and cancer-related education/work interruption on distress. Although there was no significant effect of education/work interruption on distress for those in the 0–12 month cohort (p=.88), survivors in the 13–24 and 25–60 month cohorts reporting education/work interruption were significantly more distressed than those not reporting education/work interruption in the respective cohorts (p<.05).
Conclusions
Young adult cancer survivors face unique challenges. These data underscore the importance of attending to cancer-related distress beyond the completion of treatment and may help inform targeted interventions to prevent or reduce significant distress and related sequelae in this population.
doi:10.1007/s00520-013-1793-8
PMCID: PMC3835730  PMID: 23568764
Young adults; Survivorship; Cancer; Distress; Psychosocial

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