Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic.

Purpose: To explore adolescent and young adults' (AYAs) experiences with participation in a mindfulness-based music therapy intervention during cancer treatment before and during the COVID-19 pandemic. Methods: Sixteen young adults (20-39 years old) who received cancer treatment and participated in a mindfulness-based music therapy intervention for anxiety and stress were interviewed using a semistructured interview guide. Interviews were audio recorded and transcribed verbatim. The interview guide contained prompts about reasons for joining the study, usual coping strategies, experience with the in-person and virtual delivery formats of the intervention, and suggestions for improvement. Themes were derived from the data using inductive content analysis methods. Results: Findings from the interviews included the following: (1) virtual group participants reported difficulty finding a private place to attend the intervention sessions, (2) participants experienced a sense of relaxation in response to intervention participation, (3) in-person group participants felt a sense of connection to the music and their family members who were present during the intervention, while virtual group participants felt a sense of connection to mindfulness, (4) virtual group participants reported that practicing music and mindfulness together was synergistic, and (5) in-person intervention delivery was preferred to virtual intervention delivery. Conclusion: This study provides insight into the contextual factors that impact satisfaction with the intervention and the effect of the intervention on anxiety and stress. Overall, while virtual mindfulness-based music therapy delivery may be more feasible, there are still important advantages to in-person delivery that should be considered in the design of future mindfulness-based music therapy interventions. ClinicalTrials.gov Identifier: NCT03709225.

Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer.

The purpose of this secondary analysis was to explore physiological, psychological, and situational influencing factors that may affect the impact of a mindfulness-music therapy intervention on anxiety severity in young adults receiving cancer treatment. Young adults receiving cancer treatment for ≥ eight weeks were recruited from adult and pediatric oncology outpatient centers at Dana-Farber Cancer Institute. Participants were asked to attend up to four, in-person (offered virtually via Zoom video conference after the onset of the COVID-19 pandemic) 45-min mindfulness-based music therapy sessions over twelve weeks with a board-certified music therapist. Participants completed questionnaires about anxiety, stress, and other cancer treatment-related outcomes before and after participating in the intervention. Changes in anxiety (i.e., PROMIS Anxiety 4a) over time were compared among baseline physiological (e.g., age or sex), psychological (e.g., stress), and situational influencing (i.e., intervention delivery format) factors using Wilcoxon-rank sum tests. Thirty-one of the 37 enrolled participants completed the baseline and post-intervention measures and were eligible for inclusion in the secondary analysis. Results revealed that higher baseline physical functioning (median change = -6.65), anxiety (median change=-5.65), fatigue (median change = -5.6), sleep disturbance (median change = -5.6),female sex (median change = -5.15), or virtual intervention delivery(median change = -4.65) were potential physiological, psychological, or situational influencing factors associated with anxiety improvement following mindfulness-based music therapy. Additional investigation into physiological, psychological, or situational influencing factors associated with anxiety response will help to tailor the design of future mindfulness-music therapy interventions to decrease psychological distress and address the unique psychosocial concerns among young adults receiving cancer treatment. Trial Registration ClinicalTrials.gov Identifier: NCT03709225.

Cancer Survivors' Perspectives of Virtual Yoga for Chronic Chemotherapy-Induced Peripheral Neuropathy Pain During the COVID-19 Pandemic.

With the rise in telehealth due to the COVID-19 pandemic, further research is needed to determine how to optimize virtual delivery of existing integrative oncology interventions for cancer treatment-related symptoms. The purpose of this qualitative analysis was to explore cancer survivors' perspectives of the acceptability and satisfaction of an 8-week, virtual yoga intervention for cancer survivors with chronic chemotherapy-induced peripheral neuropathy pain. Fourteen participants with chronic chemotherapy-induced peripheral neuropathy pain who completed the virtual yoga intervention were interviewed using a semistructured interview guide. Themes were derived from the data using inductive content analysis methods. Main findings from the interviews included the following: (1) participants were willing to try new nonpharmacological treatments for chemotherapy-induced peripheral neuropathy due to the high symptom burden and prior lack of success with medications; (2) participants highly rated the flexibility offered by the virtual format, but desired the social support potentially offered by practicing in-person yoga; and (3) the impact of virtual yoga on chemotherapy-induced peripheral neuropathy severity was unclear. There were several barriers to participants' use of virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain (eg, technology, lack of space/equipment). The results may be used to improve the design and delivery of future trials testing virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain.

Exploring the Feasibility of a Mindfulness-Music Therapy Intervention to Improve Anxiety and Stress in Adolescents and Young Adults with Cancer.

CONTEXT: Adolescent and young adults (AYAs) with cancer experience significant psychological distress due to cancer treatment that can persist long after treatment. However, little is known regarding optimal interventions to support the psychosocial needs of AYAs with cancer. OBJECTIVE: The overall objective of this single arm, longitudinal, pilot study was to determine the feasibility of implementing a mindfulness-based music therapy intervention to improve anxiety and stress in AYAs receiving cancer treatment. METHODS: AYAs (15 - 39 years old) who were to receive cancer treatment for ≥ eight weeks were recruited from the pediatric, melanoma, sarcoma, breast, lymphoma, and leukemia oncology outpatient centers at Dana-Farber Cancer Institute. The music therapy intervention included four sessions of individual mindfulness-based music therapy in-person or using Zoom over twelve weeks. Prior to-and after the intervention period, participants completed the Patient-Reported Outcomes Measurement Information Anxiety 4a and Perceived Stress Scale. Changes in patient-reported outcomes are compared using Wilcoxon signed-rank tests. RESULTS: Over ∼14 months, 37 of 93 eligible AYAs were enrolled to the study (39.8% consent rate). Overall, 27 of 37 (73%) participants (Median age=32; 56.8% Female) completed at least two music therapy sessions and the baseline measures and end of study measures. Participation in the mindfulness-based music therapy sessions resulted in significant pre-to-posttest improvements in perceived stress (median change: -4.0, P = 0.013) and non-significant changes in anxiety (median change: -1.9, P = 0.20). Satisfaction and acceptability were highly rated. CONCLUSIONS: The delivery of a four-session mindfulness-based music therapy intervention to AYAs receiving chemotherapy was feasible and significantly improved perceived stress. These preliminary findings should be confirmed in a randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03709225.

Mobile Health App for Prostate Cancer Patients on Androgen Deprivation Therapy: Qualitative Usability Study.

BACKGROUND: Androgen deprivation therapy (ADT) increases the risk of metabolic adverse effects among patients with prostate cancer. The transformative impact of mobile health (mHealth) apps may benefit men managing activity and nutrition at home. OBJECTIVE: This study aimed to evaluate the usability and patient experience of a newly developed mHealth app among prostate cancer patients on ADT and physicians' beliefs about the potential benefits of using this app. METHODS: This study took place over 2 months, beginning in March 2019. A sample of 5 patients (age 45-75 years) initiating ADT participated in a semistructured focus group discussion with a facilitator. The study participants also included 5 specialist physicians who provided in-depth interviews. An institutional review board-approved script was used to guide both the focus group and physician interviews. Usability was tested through specific scenarios presented to the patients, including downloading the mHealth app, entering information on physical activity and meals, and navigating the app. The focus group and interviews were audio recorded and transcribed. Content analysis was used to analyze the transcripts iteratively and exhaustively. Thematic discrepancies between reviewers were resolved through consensus. RESULTS: The mean age of the patients was 62 years. This group included 4 White and 1 Latin American patients. The physician specialists included 2 urologists, 2 medical oncologists, and 1 radiation oncologist. Analyses revealed that the patients appreciated the holistic care enabled by the app. Difficulties were observed with registration of the app among 60% (3/5) of the patients; however, all the patients were able to input information about their physical activity and navigate the options within the app. Most patients (4/5, 80%) were able to input data on their recent meal. Among the health care physicians, the dominant themes reflected in the interviews included undermining of patients ability to use technology, patients' fear of technology, and concern for the ability of older patients to access technology. CONCLUSIONS: The patients reported an overall positive experience of using an mHealth app to record and track diet and exercise. Usability was observed to be an important factor for adoption and was determined by ease of registration and use, intuitive appearance of the app, and focus on holistic cancer care. The physicians believed that the app was easy to use but raised concerns about usability among older men who may not typically use smartphone apps.

Preserving Oneself in the Face of Uncertainty: A Grounded Theory Study of Women With Ovarian Cancer.

PURPOSE: To describe the cancer care process as it is perceived by women with ovarian cancer. PARTICIPANTS & SETTING: 18 English-speaking adult women with ovarian cancer were recruited from an advocacy organization for patients with ovarian cancer and the gynecologic oncology clinic at a community-based teaching hospital in Burlington, Massachusetts. METHODOLOGIC APPROACH: A grounded theory approach was used. Data were collected via individual interviews with participants. FINDINGS: An overarching theme of preserving oneself in the face of uncertainty was described by the participants. Trajectories from prediagnosis to treatment were influenced by the quality of patient-provider communication, support from significant others, and self-concept aspects. IMPLICATIONS FOR NURSING: Comprehensive care that validates patient concerns and supports information exchange is essential. Nurses can promote the physical and psychological well-being of women with ovarian cancer by identifying institutional and community-based resources for support and specialty care.

Self-Care Support for Patients with Gastrointestinal Cancer: iCancerHealth.

BACKGROUND: Patient-centered symptom assessment and management tools allow patients to perform self-assessments and engage in self-symptom management. Efficacious tools exist for reducing symptom distress; however, little is known about feature-specific use. OBJECTIVES: This article evaluates the feasibility of the iCancerHealth app as an adjunct to usual patient education regarding cancer symptoms and medication management. METHODS: We conducted a single-arm, pilot study grounded in the health outcomes model. Our evaluation included (1) enrollment rates, (2) 2-month utilization rates, (3) patient acceptability, and (4) clinician satisfaction with the provider-side application. English-speaking, adult patients receiving care in the gastrointestinal oncology service of a comprehensive cancer center were invited to participate. Research coordinators enrolled consenting participants who had a personal, Internet-connected device; participants registered and used the platform to complete the baseline symptom assessment in clinic. Participants were reminded weekly to use the app and to perform a symptom report 4 to 6 weeks later. RESULTS: A total of 64 patients were approached, of which 57 (89%; 95% exact confidence interval [CI], 79-96%) enrolled. About half were ≥ 60 years old and 40% were women. Fifty-three patients (93%; 95% exact CI, 85-99%) accessed at least one app feature, at least once, from home. The most frequently used (86%) feature was Health Tracker in which participants monitored and reported symptoms; followed by My Inbox (63%) and My Medications features (60%). The mean acceptability score was 24.8 (standard deviation = 4.2), indicating good acceptability. Clinicians reported that the app was most acceptable with regard to facilitating in-person interactions that occurred after app use. CONCLUSION: In a sample of adults with various stages of gastrointestinal malignancies, the iCancerHealth app was utilized at a high rate. Features that focused on symptoms and medication side effects plus communication with clinicians were used most frequently. This extends our understanding of preferences and specific feature use with patient-centered technologies.

Patient, physician, and caregiver perspectives on ovarian cancer treatment decision making: lessons from a qualitative pilot study.

BACKGROUND: Ovarian cancer is the deadliest gynecologic malignancy and the fifth leading cause of cancer death among women living in the USA. Treatment for ovarian cancer that follows the guidelines published by the National Comprehensive Cancer Network is associated with a 33% decrease in disease-specific mortality, yet fewer than 40% of women with ovarian cancer receive guideline-adherent treatment. Little is known about the process by which women with ovarian cancer, their unpaid caregivers, and physicians make decisions about ovarian cancer treatment. We are planning to conduct a population-based study examining the ovarian cancer treatment decision-making process from the perspective of women with ovarian cancer, their caregivers, and physicians using a qualitative approach. Prior to embarking on a large-scale study, we determined it would be beneficial to pilot test our unpaid caregiver recruitment protocol and identify preliminary topics for the main study's interview guide. METHODS: We conducted a cross-sectional descriptive study using a qualitative approach. Data were collected via unstructured, individual interviews. Data were analyzed using modified grounded theory methods. RESULTS: We interviewed six women with ovarian cancer, four unpaid caregivers, and three physicians. The recruitment protocol successfully recruited patient participants but did not allow for direct recruitment of unpaid caregivers, which presented logistical difficulties. The interview guide was adequate to elicit participants' discussion of the major topics of interest; however, the opening statement needed modification to account for physician participants' specialties. Patient and caregiver participants identified three major categories of concepts describing the process of ovarian cancer treatment decision making: (a) choosing a provider, (b) choosing a facility, and (c) choosing a treatment. All three groups of participants addressed the influence of geographic location on treatment decisions, while physicians described encounters with patients declining recommended treatment. CONCLUSIONS: This pilot study met our objectives of testing unpaid caregiver recruitment procedures and identifying topics to include in the interview guide for a planned grounded theory study. Although the thematic results of this study are preliminary, the categories of concepts described by participants provide a framework for the exploration of patient, unpaid caregiver, and physician perspectives of ovarian cancer treatment decision making.

Integrative Therapeutic Approaches for the Management and Control of Nausea in Children Undergoing Cancer Treatment: A Systematic Review of Literature.

Chemotherapy-induced nausea and vomiting (CINV) continues to be a common symptom experienced by children undergoing cancer treatment despite the use of contemporary antiemetics. Integrative therapeutic approaches in addition to standard pharmacologic antiemetic regimes offer potential to control CINV. The purpose of this review was to identify current evidence on integrative therapeutic approaches for the control of CINV in children with cancer. Online search engines (PubMed, CINAHL, PsychINFO) were queried using MESH terms. Titles, abstracts, and then full-text articles were reviewed for relevance to the review. The search resulted in 53 studies. Twenty-one studies met our review criteria. Integrative therapies identified included acupuncture/acupressure, aromatherapy, herbal supplements, hypnosis, and other cognitive behavioral interventions. Our review identified little information on the effectiveness and safety of most integrative therapeutic approaches for the control and management of CINV in children with cancer. However, evidence from adult cancer studies and some pediatric studies identify promising interventions for further testing.

Mind-Body Exercises for Nurses with Chronic Low Back Pain: An Evidence-Based Review.

Background. Chronic low back pain (CLBP) among nurses is a growing health concern. The multimodal nature of mind-body exercises has potential to impact physiological and psychological processes associated with chronic pain, affording possible advantages over conventional unimodal therapies. This paper summarizes the prevalence of and risk factors for CLBP among nurses, reviews the effectiveness in treating pain and disability of mind-body exercises (yoga and tai chi) for CLBP among the general and nursing population, and describes implications. Methods. Articles, published during or prior to 2015, were systematically identified through the PubMed/MEDLINE, Web of Science, and ScienceDirect databases using the following search terms: nurses, mind-body, integrative, biopsychosocial, yoga, tai chi, back pain, and/or risk factors. Results. Prevalence estimates of CLBP among nurses ranged from 50% to 80%. Associated risk factors for CLBP included lifestyle and physical, psychological, psychosocial, and occupational factors. No published studies were identified that evaluated yoga or tai chi for nurses with CLBP. Studies in the general population suggested that these interventions are effective in reducing pain and disability and may improve factors/processes predictive of CLBP. Conclusion. This review suggests that evaluating the impact of multimodal interventions such as yoga and tai chi for nurses with CLBP warrants investigation.

Treatment Decision Making in Patients with Bladder Cancer.

Background: Each stage of bladder cancer involves varying treatment issues and concerns that are discussed between patients and providers during the pre-treatment consultation. There is no documentation of how patients engage in decision making. Objective: To describe aspects of treatment decision making perceived by patients with bladder cancer using qualitative analysis of data from individual interviews. Methods: Patients with any stage bladder cancer were recruited from urology and medical oncology services at a comprehensive cancer center. A qualitative approach to data collection and analysis was applied. Individual, semi-structured interviews were conducted, recorded and transcribed. Coding of the transcripts was conducted by research team members, discussed for consensus and major themes derived. Results: 45 men and 15 women, the majority college educated, were recruited. Where to receive care, including from whom, was the initial and major decision. Challenges of decisions regarding urinary reconstruction were dominant. Personal characteristics, including age and being active, were considered. Participants with early stage tumors (n = 28) typically perceived only one treatment option and followed the physician's recommendation. The 18 participants with stage II-III were aware of multiple options. In 14 stage IV participants, balancing quality of life and outcomes between treatments was common to the decision process. Conclusions: For this educated sample with bladder cancer, recruited at a comprehensive cancer center, the major decision was to seek treatment at a location with the highest level of physician expertise. Personal preferences informed decisions surrounding bladder reconstruction. Further research will be conducted in a diverse sample of patients making decisions in a non-urban, community setting.

Patient cues and symptoms of psychosocial distress: what predicts assessment and treatment of distress by oncology clinicians?

OBJECTIVE: Psychosocial concerns arise after a cancer diagnosis and during treatment requiring oncology clinicians to initiate discussions to identify distress. This study examined patient-clinician communication about psychosocial concerns and predictors of assessment and treatment/referral for distress. METHODS: Secondary analysis of existing dataset coded to explore patient-clinician communication during ambulatory visits in two comprehensive cancer centers was carried out. Sample included adult patients with various cancers and stages. Dataset included audio-recordings and symptom/QOL reports 4-6 weeks after starting treatment from all distressed patients (n = 66) in parent study and random sample of nondistressed patients (n = 23). Distressed patients had moderate-to-severe depression (Patient Health Questionnaire-9 scores ≥10) and/or poor emotional functioning (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire emotional function scores <50). Audio-recordings were coded to describe patient-clinician communication about psychosocial concerns using the coding scheme from the parent study plus Medical Interview Aural Rating System. RESULTS: The remaining patients gave 222 cues of psychosocial concerns: 183 from 46 distressed patients and 39 from nine nondistressed patients. Distressed patients were younger, were female, had higher symptom burden, and/or gave more cues. Significantly, more distressed patients had at least one cue/visit. Clinicians initiated 62% of discussions overall with no statistical difference between distressed and nondistressed groups. More explicit cues and more than four cues predicted treatment/referral for distress. CONCLUSIONS: Distressed patients were younger, were female, had higher symptom burden, and/or gave more verbal cues. Clinicians responded to explicit and more frequent cues by providing treatment and/or referrals for distress. Further exploration is needed regarding clinician factors related to assessment of psychosocial concerns.

Patient self-appraisal of change and minimal clinically important difference on the European organization for the research and treatment of cancer quality of life questionnaire core 30 before and during cancer therapy.

BACKGROUND: Clinical interpretation of health related quality of life (HRQOL) scores is challenging. The purpose of this analysis was to interpret score changes and identify minimal clinically important differences (MCID) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) before (T1) and during (T2) cancer treatment. METHODS: Patients (N = 627) in stem cell transplant (SCT) and medical (MED) or radiation (RAD) oncology at two comprehensive cancer centers, enrolled in the Electronic Self-Report Assessment-Cancer study and completed the QLQ-C30 at T1 and T2. Perceived changes in five QOL domains, physical (PF), emotional (EF), social (SF), cognitive functioning (CF) and global quality of life (QOL), were reported using the Subject Significance Questionnaire (SSQ) at T2. Anchored on SSQ ratings indicating "improvement", "the same", or "deterioration", means and effect sizes were calculated for QLQ-C30 score changes. MCID was calculated as the mean difference in QLQ-C30 score changes reflecting one category change on SSQ rating, using a two-piece linear regression model. RESULTS: A majority of SCT patients (54%) perceived deteriorating global HRQOL versus improvement (17%), while approximately equal proportions of MED/RAD patients perceived improvement (25%) and deterioration (26%). Global QOL decreased 14.2 (SCT) and 2.0 (MED/RAD) units, respectively, among patients reporting "the same" in the SSQ. The MCID ranged 5.7-11.4 (SCT) and 7.2-11.8 (MED/RAD) units among patients reporting deteriorated HRQOL; ranged 2.7-3.4 units among MED/RAD patients reporting improvement. Excepting for the global QOL (MCID =6.9), no meaningful MCID was identified among SCT patients reporting improvement. CONCLUSIONS: Cancer treatment has greater impact on HRQOL among SCT patients than MED/RAD patients. The MCID for QLQ-C30 score change differed across domains, and differed for perceived improvement and deterioration, suggesting different standards for self-evaluating changes in HRQOL during cancer treatment. Specifically, clinical attention can be focused on patients who report at least a 6 point decrease, and for patients who report at least a 3 point increase on QLQ-C30 domains. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov: NCT00852852.

Screening for religious/spiritual struggle in blood and marrow transplant patients.

PURPOSE: A growing body of research documents the harmful effects of religious/spiritual (R/S) struggle (e.g., feeling abandoned or punished by God) among patients with a wide variety of diagnoses. Documented effects include poorer quality of life, greater emotional distress, poorer recovery, and increased disability. This study reports the use of a screening protocol that identified patients who may have been experiencing R/S struggle. We also examined the prevalence and correlates of possible R/S struggle, its association with quality of life, pain, and depressive symptoms and compared the results from the screening protocol with social workers' assessments. METHODS: One hundred seventy-eight blood and marrow transplant patients completed the Electronic Self-Report Assessment--Cancer (ESRA-C) which included the Rush Religious Struggle Screening Protocol and other measures of quality of life, pain, and depressive symptoms prior to transplant therapy. All participants were assessed by a social worker, 90 % within 2 weeks of the ESRA-C assessment. RESULTS: Using the Rush Protocol, 18 % of the patients were identified as potentially experiencing R/S struggle. R/S struggle was not reported in any social work assessments. In a multivariable model, potential R/S struggle was more likely in patients who were more recently diagnosed, male, and Asian/Pacific Islanders. There were no significant associations between potential R/S struggle and quality of life, pain, or depressive symptoms. CONCLUSIONS: Early identification of patients with R/S struggle will facilitate their referral for further assessment and appropriate intervention. Further research is needed to identify the best methods of screening patients for R/S struggle.

Factors associated with pain among ambulatory patients with cancer with advanced disease at a comprehensive cancer center.

PURPOSE: The prevalence and severity of pain have not been well described among oncology patients in ambulatory care. To better understand the burden of pain among patients with advanced cancer, we examined the prevalence of pain reported during office and treatment visits. METHODS: A retrospective study of 4,014 patients with advanced disease (stage 4 at diagnosis or metastatic progression) who completed an ambulatory visit between 2004 and 2006 was conducted at a comprehensive cancer center in Boston, Massachusetts. RESULTS: At their first visit during the study period, 74% of patients reported no pain (0 score); 12%, low pain (1 to 3 score); 9%, moderate pain (4 to 6 score); and 5%, severe pain (7 to 10 score). The prevalence of pain was highest among patients who were younger than 60 years of age, were nonwhite, did not speak English as their primary language, or were covered by Medicaid, received free care, or paid their own health care costs. Patients with thoracic, breast, and head and neck cancers had higher pain scores than those with other diseases. Pain was reported more frequently among patients whose diagnosis or metastatic progression occurred less than 3 months before the reported pain score. In multivariable regression analysis, age, race, cancer type, and time since diagnosis/progression were identified as important factors associated with severe pain. CONCLUSION: Younger age, minority race, and recent onset of advanced disease are associated with severe pain among patients with cancer. Recognizing these high-risk groups could inform targeted interventions to address pain care in ambulatory patients with advanced cancer.

Incidence of severe pain in newly diagnosed ambulatory patients with stage IV cancer.

BACKGROUND: Pain is common among cancer patients. OBJECTIVE: To characterize the incidence of severe pain among newly diagnosed patients with stage IV cancer in ambulatory care. METHODS: A retrospective cohort of 505 ambulatory oncology patients with newly diagnosed stage IV solid tumours at a comprehensive cancer centre (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) was followed from January 1, 2004, to December 31, 2006. Pain intensity scores were extracted from electronic medical records. The incidence of severe pain was calculated using the maximum monthly pain scores reported at outpatient visits. RESULTS: Of the 505 patients included in the present study, 340 (67.3%) were pain-free at the initial visit, 90 (17.8%) experienced mild pain, 48 (9.5%) experienced moderate pain and 27 (5.4%) experienced severe pain. At least one episode of severe pain within one year of diagnosis was reported by 29.1% of patients. Patients with head and neck, gastrointestinal and thoracic malignancies were more likely to experience severe pain compared with patients with other types of cancer (52.6%, 33.9% and 30.5%, respectively). In the multivariable model, patients whose primary language was not English (OR 2.90 [95% CI 1.08 to 7.80]), patients who reported severe pain at the initial visit (OR 9.30 [95% CI 3.72 to 23.23]) and patients with head and neck (OR 10.17 [95% CI 2.87 to 36.00]) or gastrointestinal (OR 4.05 [95% CI 1.23 to 13.35]) cancers were more likely to report severe pain in the following year. CONCLUSIONS: The incidence of severe pain was high in ambulatory patients with newly diagnosed stage IV cancer.

Feasibility pilot on medication adherence and knowledge in ambulatory patients with gastrointestinal cancer.

PURPOSE/OBJECTIVES: To evaluate the feasibility of face-to-face education, a nurse-initiated telephone call, and patient use of medication diaries to support patients' self-reported medication adherence and knowledge of oral chemotherapy. DESIGN: Descriptive, feasibility pilot study. SETTING: An outpatient oncology unit at a National Cancer Institute-designated comprehensive cancer center. SAMPLE: 30 patients with gastrointestinal cancer who were prescribed at least one oral chemotherapy agent. METHODS: Participants received verbal and written education and a nurse-initiated educational telephone call within 72 hours of receiving education. Each was asked to complete a medication diary at home during the first cycle and the eight-item Morisky Medication Adherence Scale (MMAS-8) at the end of the first cycle of oral chemotherapy. MAIN RESEARCH VARIABLES: Verbal and written education, telephone contacts, drug diary, self-reported medication adherence, and patient knowledge. FINDINGS: Most patients (n = 29) received both verbal and written education, participated by telephone (n = 25), and completed the medication diaries (n = 21) correctly. Seventeen participants documented side effects within the first 72 hours of treatment initiation, with eight participants needing additional assistance with management of side effects. At the end of the first cycle of therapy, MMAS-8 adherence scores were high (X = 7.89, SD = 0.55). CONCLUSIONS: This study demonstrated the feasibility of a nurse-initiated educational and monitoring protocol for patients with gastrointestinal cancer receiving oral chemotherapy. In addition, the adapted MMAS-8 was a feasible adherence measure. IMPLICATIONS FOR NURSING: Pilot findings support targeted nurse interventions with face-to-face and telephone education to enhance self-monitoring and adherence for patients with gastrointestinal cancer receiving oral chemotherapy.

Assessing the quality of pain care in ambulatory patients with advanced stage cancer.

CONTEXT: Pain is common among patients with advanced cancer despite the dissemination of clinical pain care guidelines. OBJECTIVES: We sought to assess the quality of pain care among patients with advanced disease. METHODS: We reviewed the records of 85 adult ambulatory patients with advanced breast, lung, and gastrointestinal cancer treated in 2004-2006. Patients' screening pain intensity scores were at least 7 of 10. Nurse reviewers completed medical record reviews of care rendered at the index visit and over the subsequent 30 days based on the 2004 National Comprehensive Cancer Network pain guideline. An expert panel then rated the quality of the evaluation, treatment, and overall pain care. We used a multivariable model to analyze guideline compliance and resolution of severe pain. RESULTS: Among advanced cancer patients with severe pain, clinicians adjusted pain medications only half the time and made few timely referrals for pain-related consultations. By 30 days after the index visit, 34% of patients continued to report severe pain. The expert panel judged the overall quality of pain care as "fair" or "poor" in about two-thirds of cases because more timely and effective intervention could have reduced the severity and duration of pain. Resolution of severe pain was associated with adjustment of pain medications at the index visit (adjusted odds ratio 3.8, 95% CI 1.3-10.6). CONCLUSION: There is room for improvement in the pain care of patients with advanced cancer. Additional research is needed to understand the reasons for poor performance.

Phase III trial of selenium to prevent prostate cancer in men with high-grade prostatic intraepithelial neoplasia: SWOG S9917.

The threat of prostate cancer and the significant and often negative impact of its treatment underscore the importance of prevention. High-grade prostatic intraepithelial neoplasia (HGPIN) has been identified as a potential premalignant lesion marking an increased risk of prostate cancer and substantial evidence suggests that men with HGPIN are in need of prostate cancer prevention. In vitro, in vivo, epidemiologic, and clinical trial evidence that selenium supplementation protects against prostate cancer motivated the study we report here: a double-blind, randomized, placebo-controlled trial of selenium 200 (µg/d) as selenomethionine in men with HGPIN. The primary endpoint was progression of HGPIN to prostate cancer over a 3-year period. This National Cancer Institute Intergroup trial was coordinated by the Southwest Oncology Group (SWOG). Of 619 enrolled patients, 423 randomized men with HGPIN (212 selenium and 211 placebo) were eligible (by central pathology review) and included in the primary analysis. Three-year cancer rates were 36.6% (placebo) versus 35.6% (selenium; P = 0.73, adjusted). The majority of patients who developed cancer on trial (70.8%, selenium and 75.5%, placebo) had a Gleason score of 6 or less than 6; there were no differences in Gleason scores between the two arms. Subset analyses included the finding of a nonsignificantly reduced prostate cancer risk (relative risk = 0.82; 95% CI: 0.40-1.69) in selenium versus placebo patients in the lowest quartile of baseline plasma selenium level (<106 ng/mL). Overall, and in all other subsets defined by baseline blood selenium levels, selenium supplementation had no effect on prostate cancer risk. The 36% prostate cancer rate in men with HGPIN indicates the association of this lesion with an elevated prostate cancer risk. Future study in this setting should focus on selenium-deficient populations and selenium pharmacogenetics.

Validity of the Patient Generated Index as a quality-of-life measure in radiation oncology.

PURPOSE/OBJECTIVES: To evaluate psychometric properties of an instrument designed to measure individualized health-related quality of life (HRQOL). DESIGN: Repeated measures of self-reported quality of life. SETTING: An outpatient radiation therapy department in the western part of the United States. SAMPLE: 86 adults with cancer receiving their first course of radiation therapy. METHODS: The Patient Generated Index (PGI), the National Comprehensive Cancer Network's Distress Thermometer (DT), and the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core-30 (QLQ-C30). MAIN RESEARCH VARIABLES: Convergent validity, responsiveness, sensitivity, and response shift. FINDINGS: PGI scores were inversely correlated with scores on the DT (r = -0.49, -0.55, -0.44; p < 0.001), as well as the role (r = 0.31, 0.4, 0.38; p < 0.01), emotional (r = 0.33, 0.41, 0.33; p < 0.01), social functioning (r = 0.27, 0.49, 0.42; p < 0.05), pain (r = -0.29, -0.39, -0.39; p < 0.01), and fatigue (r = -0.35, -0.25, -0.47; p < 0.05) QLQ-C30 subscales at all measurement times. The PGI was responsive to those reporting high or low DT scores (t = 4.42, 3.32, 2.9; p < 0.05). A small-to-moderate effect size was detected in those who had an increase (effect size = 0.51) or decrease (effect size = 0.38) in HRQOL over time. Participants reconceptualized HRQOL over time. CONCLUSIONS: Data supported the PGI as a valid measure of individualized HRQOL. IMPLICATIONS FOR NURSING: The PGI potentially provides a more patient-centered measure of HRQOL in patients with cancer. Additional testing is needed in larger, more diverse groups.