Financial toxicity among people with metastatic cancer: findings from the Cancer Experience Registry.

PURPOSE: This study describes financial toxicity (FT) reported by people with metastatic cancer, characteristics associated with FT, and associations between FT and compensatory strategies to offset costs. METHODS: Cancer Support Community's Cancer Experience Registry data was used to identify respondents with a solid tumor metastatic cancer who completed the Functional Assessment of Chronic Illness Therapy COmprehensive Score for Financial Toxicity (FACIT-COST) measure. Multivariable logistic regression analyses examined associations between respondent characteristics and FT, and FT and postponing medical visits, nonadherence to medications, and postponing supportive and/or psychosocial care. RESULTS: 484 individuals were included in the analysis; the most common cancers included metastatic breast (31%), lung (13%), gynecologic (10%), and colorectal (9%). Approximately half of participants (50.2%) reported some degree of FT. Those who were non-Hispanic White, Hispanic, or multiple races (compared to non-Hispanic Black), and who reported lower income, less education, and being less than one year since their cancer diagnosis had greater odds of reporting FT. Individuals with any level of FT were also more likely to report postponing medical visits (Adjusted Odds Ratio [OR] 2.58; 95% Confidence Interval [CI] 1.45-4.58), suboptimal medication adherence (Adjusted OR 5.05; 95% CI 2.77-9.20) and postponing supportive care and/or psychosocial support services (Adjusted OR 4.16; 95% CI 2.53-6.85) compared to those without FT. CONCLUSIONS: With increases in the number of people living longer with metastatic cancer and the rising costs of therapy, there will continue to be a need to systematically screen and intervene to prevent and mitigate FT for these survivors.

National Cancer Institute funding for rapid cycle interventional research in cancer care delivery.

BACKGROUND: Rapid cycle interventional research can accelerate improvements to cancer care delivery and patient health outcomes by answering multiple questions as part of a single research study. To complement ongoing efforts to increase awareness of and support for rapid cycle interventional research, we conducted a systematic portfolio analysis of research grants funded by the National Cancer Institute on the topic. METHODS: We used standard portfolio analytic methods for identifying, coding, and synthesizing rapid cycle interventional research funded by the National Cancer Institute between 2016 and 2022. A codebook was used to standardize assessment of the grants by common study characteristics, intervention topics, and cancer care delivery context. RESULTS: We identified 26 grants, mostly funded since 2019, as rapid cycle interventional research. Most studies included adult or older adult target populations, used electronic systems for intervention delivery, and focused primarily on testing different components of interventions. Studies also used a range of study designs, intervention content areas, cancer sites, and across the cancer control continuum. CONCLUSIONS: The current portfolio analysis of funded rapid cycle interventional research grants suggests a growing albeit relatively small number of studies in this area. Several efforts are needed to continue to grow this area of research, including training programs, funding opportunities, and strengthening research-practice partnerships. This analysis provides a snapshot of current studies and highlights the opportunity for growing this important area of research to optimize cancer care delivery and improve patient outcomes.

National Cancer Institute-Funded Social Risk Research in Cancer Care Delivery: Opportunities for Future Research.

BACKGROUND: Cancer patients and survivors with food insecurity, housing instability, and transportation-related barriers face challenges in access and utilization of quality cancer care thereby adversely impacting their health outcomes. This portfolio analysis synthesized and described National Cancer Institute (NCI)-supported social risk research focused on assessing food insecurity, housing instability, and transportation-related barriers among individuals diagnosed with cancer. METHODS: We conducted a query using the National Institutes of Health iSearch tool to identify NCI-awarded extramural research and training grants (2010-2022). Grant abstracts, specific aims, and research strategies were coded for research characteristics, study population, and outcomes. RESULTS: Of the 30 grants included in this analysis, most assessed transportation-related barriers as patient-level social needs. Grants focused on community-level social risks, food insecurity, and housing instability were largely absent. Most grants included activities that identified the presence of social risks and/or needs (n = 24), connected patients to social care resources (n = 10), and engaged community members or organizations to inform the research study (n = 9). Of the grants, 18 focused on a single type of cancer, primarily breast cancer, and more than half focused on the treatment and survivorship phases. CONCLUSIONS: In the last decade, there has been limited NCI-funded social risk research grants focused on food insecurity and housing instability. Findings highlight opportunities for future cancer care delivery research, including community and health system-level approaches that integrate social and clinical care to address social risks and social needs. Such efforts can help improve outcomes of populations that experience cancer health and health-care disparities.

Associations between mental health and care experiences among older adults with cancer.

OBJECTIVE: We sought to understand whether people with cancer who received mental health services reported different care experiences than those who did not. METHODS: We used Surveillance, Epidemiology, and End Results (SEER)-Consumer Assessment of Health Providers and Systems (CAHPS) linked data to identify Medicare beneficiaries aged 66 and over diagnosed with solid tumor malignancies between 8/2006 and 12/2013. We identified mental health services using claims spanning 12 months before cancer diagnosis through up to 5 years afterward. Outcomes were care experience ratings (e.g., Overall Care) and composite measures (e.g., Doctor Communication). We estimated frequentist and Bayesian regression models adjusted for standard confounders, including sociodemographics, general and mental health status (MHS), and other characteristics. Models included interaction terms to understand whether mental healthcare changes self-reported experiences for individuals with adverse MHS. RESULTS: Approximately 22% (n = 4998 individuals with cancer) had a mental health disorder claim; 17% of these reported fair/poor MHS versus only 7% of those in the cancer-only cohort (without a mental health disorder claim). Before adjusting for mental healthcare utilization and case-mix, worse MHS was associated with worse care experiences (p < 0.001 for all six measures). After accounting for mental health disorder-related healthcare utilization and case mix, multivariable regression models showed no associations between MHS and worse care experiences. CONCLUSIONS: Care for mental health disorders mediates the association between MHS and perceived care experiences. The results suggest that mental health treatment may improve the self-reported experiences of care for older adults with cancer and adverse mental health issues.

Current state of funded National Institutes of Health grants focused on individuals living with advanced and metastatic cancers: a portfolio analysis.

PURPOSE: The National Cancer Institute has supported cancer survivorship science for many years, yet few funded studies have examined the needs of individuals living with cancer that is advanced or has metastasized. This report analyzes currently active National Institutes of Health (NIH) grants focused on survivorship for patients living with advanced or metastatic cancers to identify emerging research topics in this population and gaps in current science. METHODS: A search of all NIH research grants that received funding in Fiscal Year 2020 focused on this population was conducted, excluding grants with a primary focus on end-of-life care, tumor progression or staging and grants for which the only outcome was survival. RESULTS: A total of 25 active grants met the inclusion criteria. Most were funded using the R01 grant mechanism and included a range of cancer types and topics such as palliative/supportive care, psychosocial support, health services, and symptom sequelae. CONCLUSIONS: Although currently funded grants focus on several important topics, gaps in the portfolio remain. There is a need to enhance the grant portfolio of research studies focused on the longitudinal examination of unmet needs, models of care delivery, impact of innovative therapies, and the impact of financial hardship for individuals living with advanced or metastatic cancer. IMPLICATIONS FOR CANCER SURVIVORS: This review of current NIH studies suggests a need for expanded research on individuals living with advanced or metastatic cancer. Moving forward, enhancing research focused on key gap areas will be critical to improve care and outcomes for this growing population.

Standards for economic analyses of interventions for the field of health psychology and behavioral medicine.

Behavioral interventions can be offered within a wide range of contexts, including public health, medicine, surgery, physical rehabilitation, nutrition, and other health services. These differing services compete for the same resources and it is difficult to compare their value. Systematic standardized methodologies for valuing outcomes are available and are being applied by economists and health services researchers, but are not widely used in our field. With support from the Society for Health Psychology, the National Cancer Institute (NCI), and the Office for Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health, two working group meetings were held to consider the use of well-established cost-effectiveness methodologies for the evaluation of behavioral and public health interventions. In this special section, we acknowledge a wide range of variability in terms of behavioral interventions typically delivered in nonclinical versus more traditional clinical settings. Three articles address (1) standardizing methods for conducting cost-effectiveness and cost-utility analyses, (2) providing examples to illustrate progress in applying these methods to evaluate interventions delivered in whole or in part in clinical settings, and (3) providing nonclinical intervention examples selected to highlight the challenges and opportunities for evaluating the cost-effectiveness of interventions in more diverse settings. The ability of our field to communicate cost-effectiveness data to policy makers, employers, and insurers that incorporates implementation costs is central to the likelihood of our interventions being adopted by practitioners and reimbursed by payers. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

The role of economic analyses in promoting adoption of behavioral and psychosocial interventions in clinical settings.

In this report, we offer three examples of how economic data could promote greater adoption of behavioral and psychosocial interventions in clinical settings where primary or specialty medical care is delivered to patients. The examples are collaborative care for depression, chronic pain management, and cognitive-behavioral therapy for insomnia. These interventions illustrate differences in the availability of cost and cost-effectiveness data and in the extent of intervention adoption and integration into routine delivery of medical care. Collaborative care has been widely studied from an economic perspective, with most studies demonstrating its relative cost-effectiveness per quality-adjusted life year (QALY) and some studies demonstrating its potential for cost neutrality or cost savings. The success of collaborative care for depression can be viewed as a model for how to promote greater adoption of other interventions, such as psychological therapies for chronic pain and insomnia. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Addressing Rural Geographic Disparities Through Health IT: Initial Findings From the Health Information National Trends Survey.

BACKGROUND: Rural communities experience disparate rates of chronic diseases and face distinct challenges in gaining access to health care. Increasing the reach of the US health information and communication technology infrastructure can support rural health by overcoming geographic and temporal health care barriers. OBJECTIVES: The goal of the study is to establish statistically valid point estimates for the use of health information technology within rural versus urban populations, and to understand the degree to which structural factors may account for the overall variance in the use of these technologies. METHODS: Data from the National Cancer Institute's 2017 Health Information National Trends Survey were used to estimate prevalence of Health IT engagement across rural and urban populations and model factors influencing use of online medical records. RESULTS: Rural residents reported similar rates of providers maintaining electronic health records and offering access to online medical records. However, rural residents with provider-maintained records were less likely to receive a provider recommendation to use online medical records and were subsequently less likely to actually access records. Observed differences in online medical record use were accounted for by variance in Internet access, access to a regular health care provider, and whether providers encouraged patients to use online records. CONCLUSIONS: Findings shed light on structural opportunities for overcoming geographic and temporal barriers to Health IT and extending the benefits of digital health information technologies to underserved populations.

Developing a Quality of Cancer Survivorship Care Framework: Implications for Clinical Care, Research, and Policy.

There are now close to 17 million cancer survivors in the United States, and this number is expected to continue to grow. One decade ago the Institute of Medicine report, From Cancer Patient to Cancer Survivor: Lost in Transition, outlined 10 recommendations aiming to provide coordinated, comprehensive care for cancer survivors. Although there has been noteworthy progress made since the release of the report, gaps remain in research, clinical practice, and policy. Specifically, the recommendation calling for the development of quality measures in cancer survivorship care has yet to be fulfilled. In this commentary, we describe the development of a comprehensive, evidence-based cancer survivorship care quality framework and propose the next steps to systematically apply it in clinical settings, research, and policy.

The role of implementation science in improving distress assessment and management in oncology: a commentary on "Screening for psychosocial distress among patients with cancer: implications for clinical practice, healthcare policy, and dissemination to enhance cancer survivorship".

Despite considerable evidence that psychosocial interventions can effectively relieve distress in patients with cancer, many individuals who could benefit from these interventions do not receive them. A proposed solution to this problem is the establishment of programs in oncology settings that routinely screen for distress and refer patients for appropriate psychosocial care. This commentary addresses a review by Ehlers et al. that describes policies and procedures related to distress screening, summarizes prior research on this topic, and identifies key areas for future research. Among their major conclusions is the need for research to fill the gap in knowledge about how best to implement new distress screening programs as well as optimize the use and efficiency of existing programs. This commentary focuses on how the types of study methods, designs, and outcomes that are commonplace in implementation science to facilitate the integration of research into practice can be applied to distress screening programs. Priorities identified include designing and conducting pragmatic clinical trials, evaluating multilevel interventions, and using hybrid designs to simultaneously evaluate clinical effectiveness and barriers and facilitators of implementation. Use of these approaches holds considerable potential for developing an evidence base that can promote more widespread adoption of effective distress screening programs and inform further development of standards and policies related to the psychosocial care of patients with cancer.

Patient-Reported Outcomes and Socioeconomic Status as Predictors of Clinical Outcomes after Hematopoietic Stem Cell Transplantation: A Study from the Blood and Marrow Transplant Clinical Trials Network 0902 Trial.

This secondary analysis of a large, multicenter Blood and Marrow Transplant Clinical Trials Network randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes, including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pretransplantation Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores of the Short-Form 36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (P < .01 considered significant given multiple testing). Lower attained education was associated with increased distress (P = .002), lower income was related to worse physical functioning (P = .005) and increased distress (P = .008), lack of employment before transplantation was associated with worse physical functioning (P < .01), and unmarried status was associated with worse sleep (P = .003). In this large heterogeneous cohort of HCT recipients, although PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage.

Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation.

PURPOSE: This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. METHODS: A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. RESULTS: It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. CONCLUSION: Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors.

Development of a symptom index for patients with primary brain tumors.

OBJECTIVES: This study's primary goals included identifying the highest priority symptoms of patients with advanced brain tumors on treatment, comparing patient priority ratings with those of oncology experts, and constructing a brief symptom index using combined input to assess these symptoms and concerns. METHODS: Fifty patients with advanced primary brain tumors and 10 physician experts were recruited from the National Comprehensive Cancer Network institutions and community support agencies. By using a 40-item symptom checklist, patients first selected up to 10 of the most important symptoms/concerns to monitor when assessing the value of drug treatment for brain tumors, then nominated up to 5 of the very most important concerns, and finally generated additional symptoms/concerns. By using the same checklist as patients, physicians rated each symptom/concern as disease- or treatment-related. RESULTS: By using the combined input, a 24-item National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Brain Symptom Index (NFBrSI-24) was developed. The NFBrSI-24 showed good internal consistency (α = 0.84), significantly differentiated patients with different levels of functional status (F2,47 = 8.21; P < .001), and demonstrated good convergent validity with the Functional Assessment of Cancer Therapy-General functional, physical, social, emotional, and brain tumor-specific concerns (ρ = 0.59, 0.57, 0.40, 0.35, and 0.50, respectively; Ps < 0.05). CONCLUSIONS: The NFBrSI-24, an index of the symptoms in advanced brain tumors perceived as most important by both patients and clinicians, improves upon existing measures of brain tumor symptoms through better satisfaction of regulatory requirements for measure development. The findings suggest good reliability and validity, indicating that the NFBrSI-24 is a promising brief assessment of high-priority advanced brain tumor symptoms for research and clinical settings.

The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice.

To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can "empower patients to make decisions based on their values" and "level the playing field between physician and patient". While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting.The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines.

Evaluation of treatment- and disease-related symptoms in advanced head and neck cancer: validation of the national comprehensive cancer network-functional assessment of cancer therapy-head and neck cancer symptom index-22 (NFHNSI-22).

CONTEXT: The Functional Assessment of Cancer Therapy-Head and Neck is a well-validated assessment of quality of life used with patients diagnosed with head and neck cancers (HCNs). The present study is an attempt to evaluate and modify this instrument as necessary in light of the recent regulatory guidelines from the Food and Drug Administration on the use of patient-reported outcomes in clinical trials. OBJECTIVES: Overall, the goal was to identify patients' highest priority cancer symptoms, compare these symptoms with those suggested by oncology experts, and construct a brief symptom index to assess these symptoms and categorize them as treatment-related, disease-related, or related to general function and well-being. METHODS: Patients (N=49) with advanced (Stages III and IV) HCNs were recruited from participating National Comprehensive Cancer Network institutions and community cancer support organizations in the Chicago area. Patients completed open-ended interviews and symptom checklists. Participating oncology physician experts also rated symptoms. Content validity was obtained by evaluating results alongside items in the Functional Assessment of Chronic Illness Therapy system. Eleven oncologists categorized symptoms in terms of importance and also whether the symptoms were primarily related to disease, treatment, or functional well-being. RESULTS: HCN-related symptoms endorsed as high priority by both patients and oncology experts were selected for the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Head and Neck Cancer Symptom Index-22. The final version includes 22 items, which are broken down into disease-related symptoms, treatment side effects, or general function and well-being. The new scale has acceptable internal consistency (Cronbach's coefficient alpha=0.86), content validity for use in chemotherapy trials of patients with advanced disease, and concurrent validity as demonstrated by moderate-to-strong correlations with the existing Functional Assessment of Chronic Illness Therapy measure. CONCLUSION: The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Head and Neck Cancer Symptom Index-22 adequately reflects symptom and side effect concerns of advanced HCN patients as well as oncology physicians. This instrument can be used to evaluate the most important disease-related symptoms, treatment side effects, and function/well-being in patients with advanced HCNs in clinical practice and research.

Assessment of elementary school students' sun protection behaviors.

BACKGROUND/OBJECTIVES: Studies suggest that excessive sun exposure in childhood contributes to the development of skin cancer later in life. METHODS: This study explores 4th grade student assessment of their sun protection behaviors. This study used baseline data collected in the Fall of 2006 for the Sun Protection for Florida's Children (SPF) project. In brief, the SPF project is a group randomized trial to test the effectiveness of a school based intervention promoting sun protection in general, and hat use in particular, in Hillsborough County Schools, Florida. The data reported in this study were collected at baseline before any intervention activities was initiated. RESULTS: The self-reported use of various methods of sun protection was low. Only a small percentage of students wore long sleeves or a hat with a brim before leaving for school. In addition, few students wore a hat with a wide brim when outside but not at school. Students spent an average of 59.1 minutes per week outdoors while attending school and 35.5 minutes during peak sun exposure. CONCLUSION: Sun exposure at school poses a significant risk to student health and more needs to be carried out to promote the use of a wide-brimmed hat and limiting student sun exposure.

Evaluation of the functional assessment of cancer therapy cognitive scale with hematopoietic stem cell transplant patients.

The current study evaluated a newly developed self-report measure of cognitive complaints with cancer patients, the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Six or 12 months following hematopoietic stem cell transplantation, participants completed a psychosocial assessment that included the FACT-Cog and a neuropsychological assessment. Using a criterion of two or more times a week, an average of 12 of a total of 50 items were endorsed as complaints on the FACT-Cog. FACT-Cog total, domain, and subscale scores were significantly correlated with measures of depression, fatigue, anxiety, and physical and mental well-being. FACT-Cog scores, with the exception of one subscale, Other People Noticed Deficits, were not significantly correlated with cognitive performance. In general, the FACT-Cog and a commonly used measure of cognitive complaints (European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 Cognitive Functioning Scale) demonstrated similar psychometric properties. However, the FACT-Cog assesses broader aspects of cognitive complaints, thereby providing greater information about the types of cognitive complaints patients are experiencing.