Salivary, lacrimal and nasal (SALANS) measure to assess side effects following radioactive iodine treatment: development, psychometric properties, and factor structure.

PURPOSE: This study aimed to develop and psychometrically evaluate a patient-reported outcome measure (PROM), SAlivary, LAcrimal, NaSal (SALANS), to document patients' symptoms after radioactive iodine (RAI) treatment for differentiated thyroid cancer (DTC). METHODS: We generated and iteratively revised SALANS items based on expert input, focus group discussions and feedback from cognitive testing (n = 17). We administered an initial SALANS measure with 39 items to patients diagnosed with DTC in the past two years (n = 105). Exploratory factor analysis (EFA) examined the factor structure of the SALANS items. We assessed the consistency reliability and related the total and subscale scores of the final SALANS to existing PROMs to assess validity. RESULTS: The final SALANS consisted of 33 items and six subscales (sialadenitis, taste, xerostomia, dry eyes, epiphora, and nasal) with six factors extracted by EFA. The six subscales demonstrated good internal reliability (α range = 0.87-0.92). The SALANS total score showed good convergent validity with the Xerostomia Inventory (r = 0.86) and good discriminant validity with a measure of spirituality (r = - 0.05). The mean SALANS total score was significantly higher (d = 0.5, p < 0.04) among patients who had RAI compared to those who did not have RAI. CONCLUSION: Preliminary evidence suggests that SALANS is a novel and reliable PROM to assess the type and frequency all symptoms experienced after RAI treatment for DTC. Future work is needed to further validate and develop the scale.

Disparities in Telehealth Offer and Use among U.S. Adults: 2022 Health Information National Trends Survey.

Objective: Understanding the sources of telehealth disparities can inform efforts to ensure equity. This study examines disparities in telehealth offer and use to understand the role of health care providers in increasing telehealth access. Methods: This cross-sectional analysis of the 2022 Health Information National Trends Survey (n = 5,295) used survey-weighted proportions to characterize telehealth use and multivariable logistic regressions to test associations of sociodemographic and social determinants with (1) telehealth offer and (2) use among those offered the option. Results: Among U.S. adults, 57% were offered telehealth, 80% of whom used it. Technology difficulties and privacy concerns were barriers for 15%-20% of U.S. adults. Compared to telehealth users, most nonusers preferred in-person care (25% versus 84%). Age, education, geographic location, and broadband internet access were related to telehealth offer, whereas no significant disparities emerged in telehealth use. Conclusions: Telehealth use is widespread, but structural and provider-level engagement are needed to achieve equity.

Analysis of Telehealth Discussion Trends on Reddit (2019-2022).

Introduction: Use of telehealth increased during the COVID-19 pandemic and continues to be a popular health resource. This study analyzed the frequency and sentiment of telehealth discussions on Reddit. Methods: The data set included 13,071 publicly available Reddit submissions containing keywords related to telehealth over a 3-year period. We identified 173 unique subreddit communities, which were coded into mutually exclusive categories: (1) general telehealth, (2) individual care, (3) professional, (4) news, and (5) COVID-19. The Vader lexicon-based machine was used to assign sentiment scores. Results: Most subreddits were coded as individual care (n = 112), professional (n = 26), and news (n = 22). The frequency of submissions increased during the first 2 months of the pandemic and dropped in June 2020, but remained consistent through October 2022. Most Reddit submissions were positive in sentiment (56%). Conclusion: Findings show a mostly positive view of telehealth among Reddit users and an increase in telehealth-related discussions since the COVID-19 pandemic.

Telehealth Availability and Use of Related Technologies Among Medicare-Enrolled Cancer Survivors: Cross-sectional Findings From the Onset of the COVID-19 Pandemic.

BACKGROUND: There has been rapid integration of telehealth into care delivery during the COVID-19 pandemic. However, little is known about technology ownership, internet access and use for communication, and telehealth availability among cancer survivors, particularly those enrolled in Medicare. OBJECTIVE: This study aims to identify sociodemographic associations with technology ownership, internet access and use for communication, and telehealth availability in a population-based sample of Medicare-enrolled cancer survivors. METHODS: Data are from the Medicare Current Beneficiary Survey COVID-19 Summer 2020 Supplement administered between June 10 and July 15, 2020. Analyses were restricted to beneficiaries who reported a prior (nonskin) cancer diagnosis and a usual source of care (N=2044). Dichotomous outcomes included technology ownership, internet access, internet use for communication, and telehealth availability from providers. Sociodemographic correlates included sex, age, race/ethnicity, Medicare/Medicaid dual enrollment, rurality, census region, and self-reported comorbidities. RESULTS: Over half (957/2044, 53%) of cancer survivors reported using the internet for communication purposes, and 62% (1218/2044) reported that their usual provider had telehealth services available. Using the internet for communication purposes was reported less frequently for rural compared to urban survivors (adjusted probability of 28% vs 46%; P<.001) and for Hispanic and Black survivors compared to non-Hispanic White survivors (29%, 31%, and 44%, respectively; all P<.01). Rural survivors reported lower telehealth availability (53% vs 63%; P<.001); no significant differences in telehealth availability were identified by race/ethnicity. CONCLUSIONS: During the COVID-19 pandemic, study findings highlight a complex digital divide among Medicare beneficiaries with a history of cancer related to device ownership necessary for telehealth, internet access and use for communication, and reports of providers having telehealth available. Multilevel approaches are needed to increase equitable telehealth availability and use for cancer survivors. Suggested strategies include increasing broadband internet access to providers and patients in at-risk communities, supporting telehealth implementation among providers that serve populations with known health disparities, raising awareness of providers' available telehealth services among patients, and screening for technology use and provision of telehealth-related technical assistance among older and historically underserved cancer survivors.

Spiritual peace and life meaning may buffer the effect of anxiety on physical well-being in newly diagnosed cancer survivors.

OBJECTIVE: To assess the extent to which spiritual well-being moderates the relationship between anxiety and physical well-being in a diverse, community-based cohort of newly diagnosed cancer survivors. METHODS: Data originated from the Measuring Your Health (MY-Health) study cohort (n = 5506), comprising people assessed within 6-13 months of cancer diagnosis. Life meaning/peace was assessed using the 8-item subscale of the Spiritual Well-Being Scale (FACIT-Sp-12). Anxiety was measured with an 11-item PROMIS Anxiety short form, and physical well-being was assessed using the 7-item FACT-G subscale. Multiple linear regression models were used to assess relationships among variables. RESULTS: Life meaning and peace was negatively associated with anxiety, b = -0.56 (P < .001) and positively associated with physical well-being, b = 0.43 (P = <.001) after adjusting for race, education, income, and age. A significant interaction between life meaning/peace and anxiety emerged (P < .001) indicating that spiritual well-being moderates the relationship between anxiety and physical well-being. Specifically, for cancer survivors high in anxiety, physical well-being was dependent on levels of life meaning/peace, b = 0.19, P < .001. For those low in anxiety, physical well-being was not associated with levels of life meaning/peace, b = 0.01, P = .541. Differences in cancer clinical factors (cancer stage at diagnosis, cancer type) did not significantly impact results. CONCLUSIONS: Further research is needed to assess how spiritual well-being may buffer the negative effect of anxiety on physical well-being. A clinical focus on spiritual well-being topics such as peace and life meaning may help cancer survivors of all types as they transition into follow-up care.

Examination of individual and multiple comorbid conditions and health-related quality of life in older cancer survivors.

PURPOSE: Older cancer survivors (≥ 65 years at diagnosis) are at high-risk for multimorbidity (2 + comorbid conditions). However, few studies have utilized a generalizable sample of older cancer survivors to understand how individual comorbid conditions, as opposed to total comorbidity burden, are associated with health-related quality of life (HRQOL). We examined associations between HRQOL outcomes (pain, fatigue, physical function), individual comorbidities (cardiovascular disease [CVD], lung disease, diabetes, arthritis) and total comorbidity (cancer-only, cancer + 1 condition, cancer + 2 or more conditions). METHODS: Utilizing a population-based sample of 2019 older cancer survivors, we tested associations between comorbid conditions and the HRQOL outcomes using generalized linear models. HRQOL domains were assessed using Patient-Reported Outcome Measurement Information System® (PROMIS®) measures. Comorbidity was assessed via self-report. RESULTS: Cancer survivors with lung disease reported significantly worse physical functioning (ß = - 4.96, p < 0.001), survivors with arthritis reported significantly higher pain (ß = 4.37, p < 0.001), and survivors with CVD reported significantly higher fatigue (ß = 3.45, p < 0.001) compared to survivors without each condition. Having cancer + 1 condition was not as strongly associated with all outcomes as when individual conditions were tested (e.g. pain: ß = 3.09, p < 0.001). Having 2+ comorbidities had a stronger association with all outcomes (e.g. physical function: ß = - 7.51, p < 0.001) than examining conditions individually. CONCLUSIONS: Knowing the specific comorbid condition profile of an older cancer survivor provides insight into specific HRQOL outcomes that may be impaired in cancer survivorship, but understanding total comorbidity burden, regardless of the specific conditions, sheds light on survivors at-risk for multiple impairments in HRQOL. This information, taken together, can inform risk-stratified survivorship care.

Characterizing the US Population by Patterns of Mobile Health Use for Health and Behavioral Tracking: Analysis of the National Cancer Institute's Health Information National Trends Survey Data.

BACKGROUND: Multiple types of mobile health (mHealth) technologies are available, such as smartphone health apps, fitness trackers, and digital medical devices. However, despite their availability, some individuals do not own, do not realize they own, or own but do not use these technologies. Others may use mHealth devices, but their use varies in tracking health, behaviors, and goals. Examining patterns of mHealth use at the population level can advance our understanding of technology use for health and behavioral tracking. Moreover, investigating sociodemographic and health-related correlates of these patterns can provide direction to researchers about how to target mHealth interventions for diverse audiences. OBJECTIVE: The aim of this study was to identify patterns of mHealth use for health and behavioral tracking in the US adult population and to characterize the population according to those patterns. METHODS: We combined data from the 2017 and 2018 National Cancer Institute Health Information National Trends Survey (N=6789) to characterize respondents according to 5 mutually exclusive reported patterns of mHealth use for health and behavioral tracking: (1) mHealth nonowners and nonusers report not owning or using devices to track health, behaviors, or goals; (2) supertrackers track health or behaviors and goals using a smartphone or tablet plus other devices (eg, Fitbit); (3) app trackers use only a smartphone or tablet; (4) device trackers use only nonsmartphone or nontablet devices and do not track goals; and (5) nontrackers report having smartphone or tablet health apps but do not track health, behaviors, or goals. RESULTS: Being in the mHealth nonowners and nonusers category (vs all mHealth owners and users) is associated with males, older age, lower income, and not being a health information seeker. Among mHealth owners and users, characteristics of device trackers and supertrackers were most distinctive. Compared with supertrackers, device trackers have higher odds of being male (odds ratio [OR] 2.22, 95% CI 1.55-3.19), older age (vs 18-34 years; 50-64 years: OR 2.83, 95% CI 1.52-5.30; 65+ years: OR 6.28, 95% CI 3.35-11.79), have an annual household income of US $20,000 to US $49,999 (vs US $75,000+: OR 2.31, 95% CI 1.36-3.91), and have a chronic condition (OR 1.69, 95% CI 1.14-2.49). Device trackers also have higher odds of not being health information seekers than supertrackers (OR 2.98, 95% CI 1.66-5.33). CONCLUSIONS: Findings revealed distinctive sociodemographic and health-related characteristics of the population by pattern of mHealth use, with notable contrasts between those who do and do not use devices to track goals. Several characteristics of individuals who track health or behaviors but not goals (device trackers) are similar to those of mHealth nonowners and nonusers. Our results suggest patterns of mHealth use may inform how to target mHealth interventions to enhance reach and facilitate healthy behaviors.

Effect of instrumental support on distress among family caregivers: Findings from a nationally representative study.

BACKGROUND AND OBJECTIVE: A priority focus on palliative and supportive care is helping the 43.5 million caregivers who care for individuals with serious illness. Lacking support may lead to caregiver distress and poorer care delivery to patients with serious illness. We examined the potential of instrumental support (assistance with material and task performance) to mitigate distress among caregivers. METHOD: We analyzed data from the nationally representative Health Information National Trends Survey (HINTS V2, 2018). Informal/family caregivers were identified in HINTS V2 if they indicated they were caring for or making healthcare decisions for another adult with a health problem. We used the PROMIS® instrumental support four-item short-form T-scores and the Patient Health Questionnaire (PHQ-4) for distress. We examined multivariable linear regression models for associations between distress and instrumental support, adjusted for sampling weights, socio-demographics, and caregiving variables (care recipient health condition(s), years caregiving (≥2), relationship to care recipient, and caregiver burden). We examined interactions between burden and instrumental support on caregiver distress level. RESULTS: Our analyses included 311 caregivers (64.8% female, 64.9% non-Hispanic White). The unweighted mean instrumental support T-score was 50.4 (SD = 10.6, range = 29.3-63.3); weighted mean was 51.2 (SE = 1.00). Lower instrumental support (p < 0.01), younger caregiver age (p < 0.04), higher caregiving duration (p = 0.008), and caregiver unemployment (p = 0.006) were significantly associated with higher caregiver distress. Mean instrumental support scores by distress levels were 52.3 (within normal limits), 49.4 (mild), 48.9 (moderate), and 39.7 (severe). The association between instrumental support and distress did not differ by caregiver burden level. CONCLUSIONS: Poor instrumental support is associated with high distress among caregivers, suggesting the need for palliative and supportive care interventions to help caregivers leverage instrumental support.

Applying PRO Reference Values to Communicate Clinically Relevant Information at the Point-of-care.

INTRODUCTION: The inclusion of reference values for common patient-reported outcomes (PROs) measures in clinical care settings provides a clinically relevant context for an individual patient's PRO scores. PRO reference values are currently not reported in clinical care settings. This is a missed opportunity, as clinicians are familiar with the presence and interpretation of reference values, commonly provided alongside laboratory test results. Incorporating PRO reference values into clinical PRO reporting requires: an understanding of the clinical purpose, the availability of an appropriate reference value, and graphical representation. METHODS FOR PRO SCORE INTERPRETATION: We present reference value terminology adapted for PROs and discuss important differences between using reference values in the PRO score interpretation compared to other types of clinical measures from clinical chemistry. We outline the basic methodological approaches in obtaining a PRO reference sample and calculating reference intervals. Lastly, we provide recommendations on how to present and use PRO reference values in clinical care settings. DISCUSSION: There is a strong, long-standing discipline behind reference value development and application in psychology and medicine, allowing for both providers and patients to understand comparisons and identify what is "out of range." PRO reference values can be communicated in a wide range of ways within clinical care settings and are adaptable as required to different patient populations or clinical care situations. However, a notable adoption barrier is the expense and methodological expertise needed to establish and apply PRO reference values effectively in clinical encounters.

Electronic patient-reported outcome systems in oncology clinical practice.

Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients.

Physical function metric over measure: An illustration with the Patient-Reported Outcomes Measurement Information System (PROMIS) and the Functional Assessment of Cancer Therapy (FACT).

BACKGROUND: Measuring patient-reported outcomes (PROs) is becoming an integral component of quality improvement initiatives, clinical care, and research studies in cancer, including comparative effectiveness research. However, the number of PROs limits comparability across studies. Herein, the authors attempted to link the Functional Assessment of Cancer Therapy-General Physical Well-Being (FACT-G PWB) subscale with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) calibrated item bank. The also sought to augment a subset of the conceptually most similar FACT-G PWB items with PROMIS PF items to improve the linking. METHODS: Baseline data from 5506 participants in the Measuring Your Health (MY-Health) study were used to identify the optimal items for linking FACT-G PWB with PROMIS PF. A mixed methods approach identified the optimal items for creating the 5-item FACT/PROMIS-PF5 scale. Both the linked and augmented relationships were cross-validated using the follow-up MY-Health data. RESULTS: A 5-item FACT-G PWB item subset was found to be optimal for linking with PROMIS PF. In addition, a 2-item subset, including only items that were conceptually very similar to the PROMIS item bank content, were augmented with 3 PROMIS PF items. This new FACT/PROMIS-PF5 provided superior score recovery. CONCLUSIONS: The PROMIS PF metric allows for the evaluation of the extent to which similar questionnaires can be linked and therefore expressed on the same metric. These results allow for the aggregation of existing data and provide an optimal measure for future studies wishing to use the FACT yet also report on the PROMIS PF metric. Cancer 2018;124:153-60. © 2017 American Cancer Society.

Sleep quality in individuals diagnosed with colorectal cancer: Factors associated with sleep disturbance as patients transition off treatment.

OBJECTIVE: To identify patient characteristics associated with sleep disturbance and worsening of sleep in individuals diagnosed with localized colorectal cancer and assess heterogeneity in these relationships. METHODS: Data were from the MY-Health study, a community-based observational study of adults diagnosed with cancer. Patient-Reported Outcomes Measurement Information System® Sleep Disturbance, Anxiety, Depression, Fatigue, and Pain Interference measures were administered. Participants self-reported demographics, comorbidities, and treatment information. Regression mixture and multiple regression models were used to evaluate the relationship between sleep disturbance and patient characteristics cross-sectionally at an average of 10 months after diagnosis (n = 613) as well as change in sleep disturbance over a 6-month period (n = 361). RESULTS: Pain, anxiety, fatigue, and the existence of multiple comorbid conditions had statistically significant relationships with sleep disturbance (B = 0.09, 0.22, 0.29, and 1.53, respectively; P < 0.05). Retirement (B = -2.49) was associated with sleep quality in the cross-sectional model. Worsening anxiety (B = 0.14) and fatigue (B = 0.20) were associated with worsening sleep disturbance, and more severe sleep disturbance 10 months after diagnosis (B = -0.21) was associated with improvement in sleep quality after diagnosis (P < 0.05). No evidence of latent subgroups of patients (heterogeneity) was present. CONCLUSIONS: Pain, anxiety, fatigue, employment, and comorbid conditions were associated with sleep disturbance, but regression coefficients were small (< |2.5|). Results suggest that screening for anxiety, depression, fatigue, or pain is not sufficient for identifying sleep disturbance. Given the negative consequences of sleep disturbance, sleep disturbance screening may be warranted.

Relationship between sleep and exercise as colorectal cancer survivors transition off treatment.

PURPOSE: The primary objective of this study was to evaluate the relationship between exercise and sleep disturbance in a sample of individuals diagnosed with stage I, II, and III colorectal cancer (CRC) as patients transitioned off first-line treatment. We also sought to identify heterogeneity in the relationship between sleep disturbance and exercise. METHODS: Data were obtained from the MY-Health study, a community-based observational study of adults diagnosed with cancer. Patient-Reported Outcomes Measurement Information System® (PROMIS) measures (e.g., PROMIS Sleep) were administered, and participants self-reported demographics, comorbidities, cancer treatment, and exercise. Regression mixture and multiple regression models were used to evaluate the relationship between sleep disturbance and exercise cross-sectionally at an average of 10 months after diagnosis, and the change in sleep disturbance over a 7-month period, from approximately 10 to 17 months post-diagnosis. RESULTS: Patients whose exercise was categorized as likely at or above American College of Sports Medicine's guidelines did not report statistically better sleep quality compared to patients who were classified as not active. However, retirement (B = - 2.4), anxiety (B = 0.21), and fatigue (B = 0.24) had statistically significant relationships with sleep disturbance (p < 0.05). Increase in exercise was not significantly associated with a decrease in sleep disturbance. No statistical heterogeneity was revealed in the relationship between sleep and exercise. CONCLUSIONS: Further prospective research using an objective measure of exercise is warranted to confirm or refute the nature of the relationship between exercise and sleep disturbance in individuals diagnosed with CRC transitioning off first-line treatment.

Understanding Breast Cancer Survivors' Beliefs and Concerns About Adjuvant Hormonal Therapy: Promoting Adherence.

Adjuvant hormonal therapy is recommended for women with hormone receptor (HR)-positive breast cancer. Though critical, many patients are non-adherent to this therapy. Few scales have been developed to specifically address beliefs about adjuvant hormonal therapy. This study explores the clarity and relevance of the Beliefs about Medicine Questionnaire (BMQ) in the context of adherence behaviors to hormonal therapy in Black and White breast cancer survivors. We recruited women diagnosed with HR-positive cancer from the Washington, DC, area. An interviewer administered a standardized survey and conducted a cognitive interview. Participants rated the BMQ across three areas: relevance, difficulty, and clarity. We coded whether the comments identified item level issues: limited applicability, unclear reference, unclear perspective, or wording or tone. In-depth interviews were conducted with women who prematurely discontinued hormone therapy. The sample (n = 30) was equally split between Black and White survivors. On average, women were 57.9 years old (SD = 9.0). Overall 77% rated scale as relevant. Cognitive interviews revealed areas of perceived limited acceptability such as the notion of becoming too dependent or the notion of becoming worse if not taking the medication. Women who discontinued hormonal therapy (n = 2) felt ambivalent towards hormonal therapy as they reported having both positive and negative beliefs about the medication. Our study findings suggest new areas for further research and instrument development to accurately measure self-reported beliefs about hormonal therapy by HR-positive breast cancer survivors.

Responsiveness of 8 Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a large, community-based cancer study cohort.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) was a National Institutes of Health-funded initiative to develop measures of symptoms and function. Responsiveness is the degree to which a measure can detect underlying changes over time. The objective of the current study was to document the responsiveness of 8 PROMIS measures in a large, population-based cancer cohort. METHODS: The Measuring Your Health study recruited 2968 patients who were diagnosed with 1 of 7 cancers between 2010 and 2012 through 4 Surveillance, Epidemiology, and End Results registries. Participants completed a baseline survey (6-13 months after diagnosis) and a 6-month follow-up survey. Changes in 8 PROMIS scores were compared with global ratings of transition, changes in performance status, and clinical events. RESULTS: Measures were responsive to 6-month declines and improvements in performance status with small to large effect sizes (ES) (Cohen d = 0.34-0.71; P < .01). Mean changes and effect sizes were larger for participants who reported declines compared with those who reported improvements. Small-to-medium ES were observed in patients who reported being "a little" worse (d = 0.31-0.56), and medium-to-large ES were observed in those who reported being "a lot" worse (d = 0.53-0.72). Hospitalized participants reported significant score increases, resulting in worsening of pain (d = 0.51), fatigue (d = 0.35), and depression (d = 0.57; all P < .01). Cancer recurrence and progression were associated with smaller increases in pain, fatigue, and sleep disturbance (d = 0.22-0.27). CONCLUSIONS: The current results indicated that all 8 PROMIS measures were sensitive to patient-perceived worsening and improvement and to major clinical events. These findings will be able to inform the design and interpretation of future research studies and clinical initiatives administering PROMIS measures. Cancer 2017;123:327-335. © 2016 American Cancer Society.

The challenge of measuring intra-individual change in fatigue during cancer treatment.

PURPOSE: To evaluate how well three different patient-reported outcomes (PROs) measure individual change. METHODS: Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS® Fatigue Short Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months. RESULTS: A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change. CONCLUSIONS: These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care.

BACKGROUND: Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. OBJECTIVES: To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. METHODS: Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. CONCLUSIONS: These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.

Effects of gender and depressive symptoms on quality of life among colorectal and lung cancer patients and their family caregivers.

OBJECTIVE: Cancer patients and their family caregivers often report elevated levels of depressive symptoms, along with poorer mental and physical health (quality of life: QOL). Although the mutuality in distress between patients and their caregivers is relatively well known, unknown are the degree to which caregivers' depressive symptoms independently predict their patient's QOL and vice versa, and whether the relations vary by cancer type or gender. METHODS: Colorectal or lung cancer patients and their caregivers (398 dyads) provided complete data for study variables (212 colorectal cancer patient dyads, 186 lung cancer patient dyads; 257 male patient dyads, 141 female patient dyads). Patients' depressive symptoms and QOL were measured approximately 4 and 12 months post-diagnosis; caregivers' depressive symptoms and QOL were measured approximately 5 months post-diagnosis. RESULTS: The actor-partner interdependence model confirmed that each person's depressive symptom level was uniquely associated with his/her own concurrent QOL. Female patients' depressive symptoms were also related to their caregivers' poorer physical and better mental health, particularly when the pair's depressive symptoms were at similarly elevated level. On the other hand, male patients' elevated depressive symptoms were related to their caregivers' poorer mental health. CONCLUSIONS: Findings suggest that QOL among patients and their family caregivers is interdependent. In light of this interdependency, psychosocial interventions for managing depressive symptoms should target both patients and their family caregivers, from which both may benefit by not only alleviating depressive symptoms but also improving QOL.

Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention.

INTRODUCTION: Few studies have evaluated interventions to improve quality of life (QOL) for Latina breast cancer survivors and caregivers. Following best practices in community-based participatory research (CBPR), we established a multi-level partnership among Latina survivors, caregivers, community-based organizations (CBOs), clinicians, and researchers to evaluate a survivor-caregiver QOL intervention. METHODS: A CBO in the mid-Atlantic region, Nueva Vida, developed a patient-caregiver program called Cuidando a mis Cuidadores (Caring for My Caregivers), to improve outcomes important to Latina cancer survivors and their families. Together with an academic partner, Nueva Vida and three CBOs established a multi-level team of researchers, clinicians, Latina cancer survivors, and caregivers to conduct a national randomized trial to compare the patient-caregiver program to usual care. RESULTS: Incorporating team feedback and programmatic considerations, we adapted the prior patient-caregiver program into an 8-session patient- and caregiver-centered intervention that includes skill-building workshops such as managing stress, communication, self-care, social well-being, and impact of cancer on sexual intimacy. We will measure QOL domains with the patient-reported outcomes measurement information system, dyadic communication between the survivor and caregiver, and survivors' adherence to recommended cancer care. To integrate the intervention within each CBO, we conducted interactive training on the protection of human subjects, qualitative interviewing, and intervention delivery. CONCLUSION: The development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers. The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers, clinicians, community partners, survivors, and caregivers.

Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients.

PURPOSE: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample. METHODS: Cancer patients 6-13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race-ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status. RESULTS: PROMIS physical function short forms showed high internal consistency (Cronbach's α = 0.92-0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r ≥ 0.68), and discriminant validity (unrelated domains all r ≤ 0.3) across survey short forms, age, and race-ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms. CONCLUSIONS: This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race-ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.