Coverage for evidence-based cancer survivorship care services.

PURPOSE: The American Society of Clinical Oncology Cancer Survivorship Committee established a task force to determine which survivorship care services were being denied by public and private payers for coverage and reimbursement. METHODS: A quantitative survey instrument was developed to determine the clinical practice-reported rates of coverage denials for evidence-based cancer survivorship care services. Additionally, qualitative interviews were conducted to understand whether coverage denials were based on payer policies, cost-sharing, or prior authorization. RESULTS: Of 122 respondents from 50 states, respondents reported that coverage denials were common ("always," "most of the time," or "some of the time") for maintenance therapies, screening for new primary cancers or cancer recurrence. Respondents reported that denials in coverage for maintenance therapies were highest for immunotherapy (41.74%) and maintenance chemotherapy (40.17%). Coverage denials for new primary cancer screenings were highest for Hodgkin lymphoma survivors needing a PET/CT scan (49.04%) and breast cancer survivors at a high risk of recurrence who needed an MRI (63.46%), respectively. More than half of survey respondents reported denials for symptom management and supportive care services. Fertility services, dental services when indicated, and mental health services were denied "always" or "most of the time" 23.1%, 22.5%, and 12.8%, respectively. Respondents reported they often had a process in place to automatically appeal denials for evidence-based services. The denial process, however, resulted in greater stress for the patient and provider. CONCLUSION: Our study demonstrates that additional advocacy with payers is needed to ensure that reimbursement policies are consistent with evidence-based survivorship care services.

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

BACKGROUND: Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. OBJECTIVE: Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. METHODS: We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. RESULTS: Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. CONCLUSIONS: The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156.

Exploring the relationship between social support and mental health status among lymphoma survivors: Does patient-centered communication really matter? A brief report.

The purpose of this study was to explore whether patient-centered communication (PCC) would partially mediate the relationship between social support and mental health status among adult survivors of non-Hodgkin's lymphoma (NHL). Methods: Secondary analysis of self-administered questionnaires mailed to 682 adults with NHL who were assumed living and had completed the baseline 2005 study (83% response rate). Adult NHL survivors (n = 566) and data were analyzed using descriptive statistics and the Sobel test. Results: PCC partially mediated the relationship between social support and three measures of mental health outcomes (SF-36 Mental Component Summary [SF36-MCS], Post-Traumatic Stress Disorder Checklist-Civilian Version [PCL-C], Impact of Cancer - Negative Impact Summary [IOCv2 NIS]). Results of the conservative Sobel test were significant (p < .01) in three mediation models. Conclusions: Future research should focus on testing interventions that target PCC and identifying additional mediators and moderators between social support and mental health outcomes among cancer survivors.

Geriatric Assessment Reveals Actionable Impairments in Hematopoietic Stem Cell Transplantation Candidates Age 18 to 80 Years.

Allogeneic hematopoietic stem cell transplantation (HCT) is a potentially curative treatment for both malignant and nonmalignant hematologic diseases; however, reported rates of treatment-related mortality approach 30%. Outcomes are worse in patients who begin HCT with functional impairments. To detect such impairments, a geriatric assessment (GA) is recommended in adults age ≥65 years. Younger HCT candidates also may be impaired because of chemotherapy regimens pre-HCT. Therefore, we hypothesized that GA can be beneficial for adult patients of all ages and subsequently created a clinical pretransplantation optimization program to assess all HCT candidates using a modified GA. One-hundred fifty-seven patients were evaluated in 4 functional domains- physical, cognitive, nutritional, and psychological-at 2 time points prior to HCT-new patient evaluation (NPE) and sign-off (SO)-between October 2017 and January 2020. At NPE, 80.9% of the patients had at least 1 domain with a functional impairment, and physical (P = .006), cognitive (P = .04), and psychological (P = .04) impairments were associated with an increased likelihood of not proceeding to HCT. In addition, patients age 18 to 39 years were more likely than older patients to have a physical function impairment (P = .001). Between NPE and SO, 51.9% of the patients had resolution of 1 or more impairments, and nutritional impairment at SO was predictive of worse overall survival (P = .01). Our study shows that GA can identify functional impairments in patients of all ages. Early identification of impairments could facilitate referrals to supportive care and resolution of impairments prior to HCT, suggesting that GA could be recommended for HCT candidates of all ages.

Relationships among uncertainty, post-traumatic stress disorder symptoms, and quality of life in non-muscle-invasive bladder cancer survivors.

PURPOSE: The aim of this study was to examine relationships among uncertainty, PTSD symptoms (PTSS), and quality of life (QOL) in non-muscle-invasive bladder cancer (NMIBC) survivors. METHODS: Eligible NMIBC survivors were identified through the North Carolina Central Cancer Registry, and 398 survivors participated in a mailed survey that measured survivor's outcomes (uncertainty, PTSS, and QOL). Structural equation modeling was used to examine the mediating effect of uncertainty and PTSS on the association between personal characteristics and QOL in NMIBC survivors. RESULTS: NMIBC survivors experienced cancer-related uncertainty; higher uncertainty was associated with male, lower income, lack of cure, and lower cognition-ability. Uncertainty was significantly and negatively associated with QOL. In addition, PTSS completely mediated the effect of uncertainty on QOL, and higher PTSS had a strong association with poorer QOL. Additionally, comorbidities, cognition-general concerns, uncertainty, and PTSS had strong negative effects on QOL. CONCLUSION: This study has identified modifiable psychosocial factors which affect QOL in NMIBC survivors. The study findings can be used in the development of interventions to improve QOL for NMIBC survivors.

A cross-sectional observational study of health-related quality of life in adults with multiple myeloma.

BACKGROUND: The purpose of this manuscript is to describe health-related quality of life (HRQoL) outcomes in a United States (US)-based sample of multiple myeloma (MM) patients and identify characteristics associated with poor HRQoL. PATIENTS AND METHODS: MM patients identified through the Tumor Registry of a Southeastern US medical center were mailed surveys assessing patient characteristics and HRQoL outcomes. HRQoL outcomes were measured using PROMIS short form instruments which included measures of global health (global physical health and global mental health), physical function, and ability to participate in social roles and activities (social function). HRQoL domain scores were summarized, and best subset linear regression was used to identify predictors of HRQoL. RESULTS: A total of 690 patients completed and returned surveys for a response rate of 64.7%. Respondents reported global physical health (44.9), global mental health (47.5), and physical function (44.1) significantly worse than the general population mean of 50 (p < .0001). Social function (49.5) did not differ significantly (p = .09). Worse socioeconomic status, higher comorbidities, not being in remission, and past receipt of radiation therapy were significantly associated with worse HRQoL. Treatment status and time since diagnosis were not associated with HRQoL outcomes. CONCLUSIONS: Patients with MM have significantly worse HRQoL than the general population. These findings warrant increased attention from clinicians and researchers. More research is needed to better describe the relationship between treatment patterns and HRQoL in patients with MM, and to identify effective interventions.

Persistent fatigue among long-term non-Hodgkin lymphoma survivors.

This study describes the prevalence and persistence of fatigue among a cohort of long-term non-Hodgkin lymphoma (NHL) survivors. Mailed surveys assessed quality-of-life including fatigue (SF-36) at baseline and five years. Logistic regression was used to identify factors associated with prevalence of fatigue at baseline and persistence of fatigue across timepoints. More than one-quarter (27.7%) of the 555 NHL survivors reported clinically meaningful fatigue at baseline and 18.7% reported persistent fatigue at five years. One-third (34.4%) reported clinically meaningful worsening of fatigue over time. Independent associations with persistent fatigue included female gender, less education, past chemotherapy, increased comorbidities, and posttraumatic stress symptoms (P <.05). Our findings suggest that one in three NHL survivors experience clinically meaningful fatigue long after their diagnosis and initial treatment. Furthermore, we found that fatigue worsens or persists for many, highlighting the need for vigilance in assessing and treating fatigue in this population.

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms.

BACKGROUND/AIMS: Many cancer survivors who received intensive treatment such as hematopoietic stem cell transplantation (HCT) experience posttraumatic stress disorder (PTSD) symptoms. PTSD is associated with lower quality of life and other symptoms that require clinical treatment. The iterative treatment decisions that happen in clinical practice are not adequately represented in traditional randomized controlled trials (RCT) of PTSD treatments. The proposed stepped-care SMART design allows for evaluation of initial response to the Cancer Distress Coach mobile app; adaptive stepped-care interventions; and precision treatment strategies that tailor treatment selection to patient characteristics. METHODS/DESIGN: HCT survivors (N = 400) reporting PTSD symptoms are being recruited at two cancer centers and randomly assigned to: 1) Cancer Distress Coach app or 2) Usual Care. The app includes educational and cognitive behavioral therapy (CBT)-based activities. Four weeks post-randomization, participants re-rate their PTSD symptoms and, based on intervention response, non-responders are re-randomized to receive video-conferenced sessions with a therapist: 3) coaching sessions in using the mobile app; or 4) CBT specific to HCT survivors. Participants complete outcome measures of PTSD, depression, and anxiety after Months 1, 3, and 6. Participant characteristics moderating intervention responses will be examined. CONCLUSIONS: This novel adaptive trial design will afford evidence that furthers knowledge about optimizing PTSD interventions for HCT survivors. To our knowledge, this study is the first SMART design evaluating PTSD symptom management in cancer survivors. If successful, it could be used to optimize treatment among a range of cancer and other trauma survivors.

A Qualitative Study of the Experiences of Living With Multiple Myeloma.

PURPOSE: To explore the ways in which multiple myeloma affects an individual's life in the modern treatment era. PARTICIPANTS & SETTING: 15 individuals with multiple myeloma and 10 clinicians were recruited from two academic medical centers in the southeastern United States. METHODOLOGIC APPROACH: Semistructured interviews were conducted with individuals with multiple myeloma and clinicians to explore the effect of a multiple myeloma diagnosis and treatment on individuals' lives. Transcribed interviews were analyzed using conventional content analysis. FINDINGS: The following four themes emerged from the analysis. IMPLICATIONS FOR NURSING: The treatment journey for those with multiple myeloma can be lifelong and may require frequent visits to an oncologist and, potentially, many successive lines of therapy. Life effects are far-reaching and long-term. Nurses should be aware of the interprofessional resources to help meet these individuals' needs. With thorough assessment, care planning, and education, nurses can play a key role in mitigating the negative effects of multiple myeloma and its treatment.

Human Flourishing in Adolescents with Cancer: Experiences of Pediatric Oncology Health Care Professionals.

PURPOSE: This study explores human flourishing (HF) in adolescents with cancer (AC) as witnessed by their health care providers, and it develops a list of critical attributes associated with HF to describe the positive outcomes witnessed. DESIGN AND METHODS: Our study used a qualitative descriptive design incorporating data from an open-ended electronic survey and semi-structured individual interviews with 17 pediatric oncology health care providers. RESULTS: We found 3 major themes (positive forward motion, connectedness, and self-character) representing 11 critical attributes of human flourishing in AC: (1) initiative and enterprise, (2) positivity and evocativeness, (3) tranquility and maturity, (4) perseverance and tenacity, (5) compassion and empathy, (6) social engagement and connection, (7) wisdom and translation into life, (8) supportive background, (9) self-awareness and self-agency, (10) transcendence and full potential, and (11) meaning-making. CONCLUSIONS: Understanding the concept of HF as it applies to the needs of AC is a step toward establishing it as a comprehensive health care goal and toward developing care provider guidelines for its promotion. PRACTICE IMPLICATIONS: Given the attributes of HF in AC, nurses can consider HF as an ultimate nursing care outcome and should focus on goals of care beyond disease treatment and symptoms mitigation when providing care for this population. Holistic, individualized assessment, timely care during each phase of treatment, and developmentally tailored intervention should be provided.

Post-traumatic stress disorder symptoms in non-muscle-invasive bladder cancer survivors: A population-based study.

OBJECTIVE: This cross-sectional study examined the prevalence of post-traumatic stress disorder (PTSD) and identified the predictive factors associated with PTSD symptoms in a population of non-muscle-invasive bladder cancer (NMIBC) survivors. METHODS: A random sample of 2,000 NMIBC survivors, identified through the North Carolina Central Cancer Registry, were sent postal mail survey. PTSD symptoms were measured using the PTSD Checklist for DSM-5 (PCL-5). Descriptive statistics and hierarchical multiple linear regression were used to examine the prevalence of PTSD and to identify the factors associated with PTSD. RESULTS: A total of 376 participants were included in the analysis. The average PCL-5 score was 7.1 (standard deviation [SD] = 10.9, range: 0-66), where higher scores represent higher levels of PTSD symptoms. The prevalence of the provisional PTSD diagnosis was 5.3% or 6.9% (after adjusting for nonresponse). In addition, 28.7% of participants met criteria for at least one PTSD symptom cluster. After controlling for other variables, participants who were younger, had active disease or unsure of status, had more comorbidities, had lower social support, and had higher cognitive concerns reported significantly higher PTSD symptoms. CONCLUSION: More than one-fourth of NMIBC survivors had PTSD symptoms. Thus, healthcare providers should assess PTSD symptoms and provide supportive care for NMIBC survivors in the survivorship phase of care.

Hospice Access and Scope of Services for Undocumented Immigrants: A Clinician Survey.

Objectives: To characterize clinician experiences of hospice access and scope of services for undocumented immigrants. Background: The 10.5 million undocumented immigrants in the United States are not covered by Medicare's hospice benefit and are at high risk for being uninsured. Limited data are available regarding hospice services for this population. Setting/Subjects: Two hundred ninety-four interdisciplinary palliative care clinicians from across the United States. Measurements: Participants completed a web-based survey regarding hospice access and scope of services for undocumented immigrants in their location. We used simple frequencies to report clinician responses and chi-square analysis to evaluate associations between response and location. We performed rapid qualitative analysis of free-text responses to identify common limitations in scope of services. Results: A majority of clinicians (68%) perceived that access to hospice was limited or unavailable for undocumented immigrants in their location, and among respondents who provided data regarding hospice scope, 38% reported that services provided to undocumented immigrants were limited compared to those provided to other patients. Reports of restricted access and scope varied by region, and those in large metropolitan areas were more likely to report restricted scope of care than those in smaller towns (43% vs. 28%; p = 0.03). In our qualitative analysis of free-text responses, common limitations in hospice scope included reduced access to medications and equipment, inability to access inpatient hospice, inadequate translation services, reduced staffing, and restricted duration of services. Conclusions: Undocumented immigrants may face barriers in accessing comprehensive hospice services. Public policy changes that improve access to hospice may improve end-of-life care for undocumented immigrants.

Health-related quality of life among non-muscle-invasive bladder cancer survivors: a population-based study.

OBJECTIVE: To examine the effect of non-muscle-invasive bladder cancer (NMIBC) diagnosis and treatment on survivors' quality of life (QoL). PATIENTS AND METHODS: Of the 5979 patients with NMIBC diagnosed between 2010 and 2014 in North Carolina, 2000 patients were randomly selected to be invited to enroll in this cross-sectional study. Data were collected by postal mail survey. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core (QLQ-C30) and the NMIBC-specific module were included in the survey to measure QoL. Descriptive statistics, t-tests, anova, and Pearson's correlation were used to describe demographics and to assess how QoL varied by sex, cancer stage, time since diagnosis, and treatment. RESULTS: A total of 398 survivors returned questionnaires (response rate: 23.6%). The mean QoL score for QLQ-C30 (range 0-100, higher = better QoL in all domains but symptoms) for global health status was 73.6, function domain scores ranged from 83.9 to 86.5, and scores for the top five symptoms (insomnia, fatigue, dyspnoea, pain, and financial difficulties) ranged from 14.1 to 24.3. The lowest NMIBC-specific QoL domain was sexual issues including sexual function, enjoyment, problems, and intimacy. Women had worse bowel problems, sexual function, and sexual enjoyment than men but better sexual intimacy and fewer concerns about contaminating their partner. Stage Ta had the highest global health status, followed by T1 and Tis. QoL did not vary by time since diagnosis except for sexual function. The cystectomy group (n = 21) had worse QoL in sexual function, discomfort with sexual intimacy, sexual enjoyment, and male sexual problems than the non-cystectomy group (n = 336). CONCLUSION: Survivors of NMIBC face a unique burden associated with their diagnosis and the often-lifelong surveillance and treatment regimens. The finding has important implications for the design of tailored supportive care interventions to improve QoL for NMIBC survivors.

Four Conversations: A Randomized Controlled Trial of an Online, Personalized Coping and Decision Aid for Metastatic Breast Cancer Patients.

Background: Anticipating and making health care decisions about appropriate or preferred treatment around end-of-life care are intellectually challenging and emotionally distressing for metastatic breast cancer (MBC) patients, new interventions are needed. Objective: This study examined the effect of Four Conversations, an online and personalized coping and decision aid curriculum, on the completion of advance care directives and shared decision making among patients and their loved ones, clinicians, and spirit. Design: Participants were randomized 1:1 to Four Conversations or wait-listed usual care conditions. Setting: Adult breast cancer survivors with metastatic disease were recruited nationally. Measurements: Electronic surveys collected self-reported demographic, clinical, and outcome data at baseline and four weeks postintervention. Results: Participants (N = 252) were mean age 53.6 ± 11.0 years; 100% female; 88% Caucasian; 67% married; and 33% employed. Over half (54%) of treatment arm participants without an advance directive completed one by study end, most (62%) felt that Four Conversations helped them quite a bit or a great deal in making a better decision, and 90% would recommend to others. Difference in the change in decisional conflict scores for treatment and control conditions was not significant (p = 0.07). Conclusions: These results suggest that Four Conversations facilitated the completion of advance care directives. Given that reductions in decisional conflict scores between the treatment and control arms were not significant, we cannot conclude that program use was associated with improved decisional conflict among MBC survivors. Online programs can be a feasible and effective alternative to in-person support.

How are patient-reported outcomes and symptoms being measured in adults with relapsed/refractory multiple myeloma? A systematic review.

PURPOSE: Patients with relapsed and/or refractory multiple myeloma (RRMM) are living longer due in part to changing treatment patterns. It is important to understand how changing treatment patterns affect patients' lives beyond extending survival. Research suggests that direct patient report is the best way to capture information on how patients feel and function in response to their disease and its treatment. Therefore, the purpose of this review is to summarize evidence of patients' experience collected through patient-reported outcomes (PRO) in RRMM patients, and to explore PRO reporting quality. METHODS: We conducted a systematic search to identify manuscripts reporting PROs in RRMM and summarized available evidence. We assessed PRO reporting quality using the Consolidated Standards of Reporting Trials (CONSORT) PRO Extension checklist. RESULTS: Our search resulted in 30 manuscripts. Thirteen unique PRO measures were used to assess 18 distinct PRO domains. Pain, fatigue, and emotional function were commonly assessed domains though reporting formats limited our ability to understand prevalence and severity of PRO challenges in RRMM. Evaluation of PRO reporting quality revealed significant reporting deficiencies. Several reporting criteria were included in less than 25% of manuscripts. CONCLUSIONS: Existing evidence provides a limited window for understanding the patient experience of RRMM and is further limited by suboptimal reporting quality. Observational studies are needed to describe prevalence, severity and patterns of PROs in RRMM overtime. Future studies that incorporate PROs would benefit from following existing guidelines to ensure that study evidence and conclusions can be fully assessed by readers, clinicians and policy makers.

Quality of Life in Non-Muscle-Invasive Bladder Cancer Survivors: A Systematic Review.

BACKGROUND: Non-muscle-invasive bladder cancer (NMIBC) represents approximately 75% of newly diagnosed patients with bladder cancer. Non-muscle-invasive bladder cancer survivors have unique chronic burdens including frequent recurrences, repeated surveillance cystoscopies and treatments, and the highest lifetime medical cost per person among all cancers. OBJECTIVE: The purpose of this study was to summarize studies assessing quality of life (QOL) in NMIBC survivors. METHODS: The literature from January 2005 to March 2017 found in PubMed, CINAHL, and PsycINFO databases was reviewed systematically. Inclusion criteria were as follows: (1) research about NMIBC survivors, (2) outcomes included QOL, (3) original research article published in peer-reviewed journals, and (4) published in English. RESULTS: A total of 15 studies were included: 14 quantitative studies and 1 mixed-methods study. Non-muscle-invasive bladder cancer survivors had significantly lower QOL compared with the general population, especially in fatigue, physical and role functioning, and mental health. Repeated transurethral resections and intravesical treatments were associated with impaired physical function and mental health. Most NMIBC survivors had concerns of urinary and bowel problems and sexual function. CONCLUSION: Despite a good prognosis, NMIBC and its treatment have a significant impact on QOL in survivors. The findings showed large burdens in NMIBC survivors and suggest that further research is needed to better understand potential opportunities to improve QOL in this population. IMPLICATIONS FOR PRACTICE: Oncology nurses are in the critical position for assessing symptoms and concerns. Oncology nurses should pay special attention to NMIBC survivors who have unique symptoms and burden with the aim of improving survivors' QOL.

Best Practices in Oncology Distress Management: Beyond the Screen.

The field of psychosocial oncology is a young discipline with a rapidly expanding evidence base. Over the past few decades, several lines of research have established that psychosocial problems, such as anxiety, depression, post-traumatic stress, fatigue, sexual dysfunction, and cognitive complaints, are common and consequential in patients with cancer. The word "distress" was chosen deliberately to capture a broad concept; consequently, distress screening is meant to function as an initial step in the more targeted evaluation of the source(s) of the patient's distress. In 2015, the American College of Surgeons' Commission on Cancer mandated psychosocial distress screening as part of their accreditation process. Similar screening requirements are in place internationally, including in Canada, where screening for distress is endorsed as the sixth vital sign and a standard of care that must be met by any Canadian health care organization providing cancer services that seeks to be accredited. Over the past few years, cancer centers around the world have been exploring optimum ways to implement and evaluate distress screening initiatives. This paper presents three approaches to distress screening implementation: (1) a model that incorporates the importance of shared values, perceived benefits, and relevant outcomes in the implementation of distress management protocols; (2) a Canadian knowledge translation application to distress screening, including triage considerations and interventions; and (3) a novel approach to distress management via the use of a mobile application to manage post-traumatic stress symptoms. In closing, future opportunities and challenges associated with the emergence of technology will be discussed.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

OBJECTIVE: To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. METHODS: In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. RESULTS: Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. CONCLUSIONS: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Nonspecialty Nurse Education: Evaluation of the Oncology Intensives Initiative, an Oncology Curriculum to Improve Patient Care

BACKGROUND: A community hospital combined its medical and surgical patients with cancer on one unit, which resulted in nurses not trained in oncology caring for this patient population. OBJECTIVES: The Oncology Intensives Initiative (ONCii) involved the (a) design and implementation of a daylong didactic boot camp class and a four-hour simulation session and (b) the examination of nurses' worries, attitudes, self-efficacy, and perception of interdisciplinary teamwork. METHODS: A two-group, pre-/post-test design was implemented. Group 1 consisted of nurses who attended the didactic boot camp classes alone, whereas group 2 was comprised of nurses who attended the didactic boot camp classes and the simulation sessions. FINDINGS: Results of data analysis showed a decrease in worries and an increase in positive attitudes toward chemotherapy administration in both groups, as well as an increase in self-efficacy among members of group 2.