Adjuvant platinum versus capecitabine for residual, invasive, triple-negative breast cancer: Patient-reported outcomes in ECOG-ACRIN EA1131.

BACKGROUND: Patient-reported outcomes (PROs) are a better tool for evaluating the experiences of patients who have symptomatic, treatment-associated adverse events (AEs) compared with clinician-rated AEs. The authors present PROs assessing health-related quality of life (HRQoL) and treatment-related neurotoxicity for adjuvant capecitabine versus platinum on the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) EA1131 trial (ClinicalTrials.gov identifier NCT02445391). METHODS: Participants completed the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) and the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale (platinum arm only) at baseline, cycle 3 day 1 (C3D1), 6 months, and 15 months. Because of early termination, power was insufficient to test the hypothesis that HRQoL, as assessed by the NFBSI-16 treatment side-effect (TSE) subscale, would be better at 6 and 15 months in the capecitabine arm; all analyses were exploratory. Means were compared by using t-tests or the Wilcoxon rank-sum test, and proportions were compared by using the χ2 test. RESULTS: Two hundred ninety-six of 330 eligible patients provided PROs. The mean NFBSI-16 TSE subscale score was lower for the platinum arm at baseline (p = .02; absolute difference, 0.6 points) and for the capecitabine arm at C3D1 (p = .04; absolute difference, 0.5 points), but it did not differ at other times. The mean change in TSE subscale scores differed between the arms from baseline to C3D1 (platinum arm, 0.15; capecitabine arm, -0.72; p = .03), but not from baseline to later time points. The mean decline in Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale scores exceeded the minimal meaningful change (1.38 points) from baseline to each subsequent time point (all p < .05). CONCLUSIONS: Despite the similar frequency of clinician-rated AEs, PROs identified greater on-treatment symptom burden with capecitabine and complemented clinician-rated AEs by characterizing patients' experiences during chemotherapy.

Fatigue and endocrine symptoms among women with early breast cancer randomized to endocrine versus chemoendocrine therapy: Results from the TAILORx patient-reported outcomes substudy.

BACKGROUND: TAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E). METHODS: Participants completed the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form, and the Functional Assessment of Cancer Therapy-Endocrine Symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Linear regression was used to model outcomes on baseline symptoms, treatment, and other factors. RESULTS: Participants (n = 458) in both treatment arms reported greater fatigue and endocrine symptoms at early follow-up in comparison with the baseline. The magnitude of change in fatigue was significantly greater for the CT+E arm than the E arm at 3 and 6 months but not at 12, 24, or 36 months. The CT+E arm reported significantly greater changes in endocrine symptoms from the baseline to 3 months in comparison with the E arm; change scores were not significantly different at later time points. Endocrine symptom trajectories by treatment differed by menopausal status, with the effect larger and increasing for postmenopausal patients. CONCLUSIONS: Adjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones. Treatment arm differences in endocrine symptoms were more evident in postmenopausal patients. LAY SUMMARY: Participants in TAILORx (Trial Assigning Individualized Options for Treatment) with early-stage hormone receptor-positive breast cancer and an intermediate risk of recurrence were randomly assigned to endocrine or chemoendocrine therapy. Four hundred fifty-eight women reported fatigue and endocrine symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Both groups reported greater symptoms at early follow-up versus the baseline. Increases in fatigue were greater for the chemoendocrine group than the endocrine group at 3 and 6 months but not later. The chemoendocrine group reported greater changes in endocrine symptoms in comparison with the endocrine group at 3 months but not later.

Breast cancer patients' insurance status and residence zip code correlate with early discontinuation of endocrine therapy: An analysis of the ECOG-ACRIN TAILORx trial.

BACKGROUND: Early discontinuation is a substantial barrier to the delivery of endocrine therapies (ETs) and may influence recurrence and survival. The authors investigated the association between early discontinuation of ET and social determinants of health, including insurance coverage and the neighborhood deprivation index (NDI), which was measured on the basis of patients' zip codes, in breast cancer. METHODS: In this retrospective analysis of a prospective randomized clinical trial (Trial Assigning Individualized Options for Treatment), women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who started ET within a year of study entry were included. Early discontinuation was calculated as stopping ET within 4 years of its start for reasons other than distant recurrence or death via Kaplan-Meier estimates. A Cox proportional hazards joint model was used to analyze the association between early discontinuation of ET and factors such as the study-entry insurance and NDI, with adjustments made for other variables. RESULTS: Of the included 9475 women (mean age, 55.6 years; White race, 84%), 58.0% had private insurance, whereas 11.7% had Medicare, 5.8% had Medicaid, 3.8% were self-pay, and 19.1% were treated at international sites. The early discontinuation rate was 12.3%. Compared with those with private insurance, patients with Medicaid (hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.23-1.92) and self-pay patients (HR, 1.65; 95% CI, 1.25-2.17) had higher early discontinuation. Participants with a first-quartile NDI (highest deprivation) had a higher probability of discontinuation than those with a fourth-quartile NDI (lowest deprivation; HR, 1.34; 95% CI, 1.11-1.62). CONCLUSIONS: Patients' insurance and zip code at study entry play roles in adherence to ET, with uninsured and underinsured patients having a high rate of treatment nonadherence. Early identification of patients at risk may improve adherence to therapy. LAY SUMMARY: In this retrospective analysis of 9475 women with breast cancer participating in a clinical trial (Trial Assigning Individualized Options for Treatment), Medicaid and self-pay patients (compared with those with private insurance) and those in the highest quartile of neighborhood deprivation scores (compared with those in the lowest quartile) had a higher probability of early discontinuation of endocrine therapy. These social determinants of health assume larger importance with the expected increase in unemployment rates and loss of insurance coverage in the aftermath of the coronavirus disease 2019 pandemic. Early identification of patients at risk and enrollment in insurance optimization programs may improve the persistence of therapy.

A Low Literacy, Multimedia Health Information Technology Intervention to Enhance Patient-Centered Cancer Care in Safety Net Settings Increased Cancer Knowledge in a Randomized Controlled Trial.

We tested whether a low-literacy-friendly, multimedia information and assessment system used in daily clinical practice enhanced patient-centered care and improved patient outcomes. This was a prospective, parallel-group, randomized controlled trial with 2 arms, CancerHelp-Talking Touchscreen (CancerHelp-TT) versus control, among adults with Stage I-III breast or colorectal cancer receiving chemotherapy and/or radiation therapy in safety net settings. Each patient was assessed for outcomes at 4 timepoints: after starting treatment (baseline), during treatment, immediately after treatment, and at follow-up assessment. The primary outcomes were health beliefs, cancer knowledge, self-efficacy, and satisfaction with communication about cancer and its treatments. Health-related quality of life (HRQOL) was a secondary outcome. A total of 129 patients participated in the study (65 intervention and 64 control), and approximately 50% of these completed the study. Patients randomized to receive the CancerHelp-TT program had a significantly larger increase in their cancer knowledge in comparison to those randomized to the control arm (effect size = .48, P = .05). While effect sizes for differences between randomized groups in self-efficacy, health beliefs, HRQOL, and satisfaction with communication were small (.10-.48), there was a consistent trend that participants in the intervention group showed larger increases over time in all outcomes compared to the control group. The CancerHelp-TT software was favorably rated by intervention participants. The CancerHelp-TT program showed promise to increase vulnerable cancer patients' cancer knowledge and adaptive health beliefs and attitudes. However, vulnerable patients may need additional interventional support in settings outside cancer clinics.

Rasch Analysis of Social Attitude Barriers and Facilitators to Participation for Individuals with Disabilities.

OBJECTIVES: To develop item banks of social attitude barriers and facilitators to participation and validate them with established instruments. DESIGN: We used the Rasch model to identify misfitting items and rating scale problems, calibrate items, and develop KeyForms and short forms. Correlations between the Social Attitude Barriers and Facilitators item banks with the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain and National Institutes of Health Toolbox Emotional Battery Social Relationships domain were computed to evaluate convergent and divergent validity. SETTING: Community-dwelling individuals traveled to 3 academic medical centers for testing. PARTICIPANTS: Participants (N=558) who had a primary impairment of stroke, spinal cord injury, or traumatic brain injury (mean age, 47.0±16.0y) completed 31 social attitude facilitator and 51 barrier items using a 5-point rating scale. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Item banks to measure social attitude barriers and facilitators for individuals with disabilities. RESULTS: After combining the "never" and "rarely" rating scale categories, 30 Facilitator items fit the Rasch model and demonstrated person reliability of 0.93. After collapsing the "never" and "rarely" rating scale categories, 45 Barrier items fit the Rasch model and demonstrated person reliability of 0.95. Ceiling and floor effects were negligible for both item banks. Facilitators and Barriers item banks were negatively correlated, and these banks were moderately correlated with PROMIS and Toolbox measures, providing evidence of convergent and divergent validity. CONCLUSIONS: Findings support the reliability and validity of the Social Attitude Facilitators and Barriers item banks. These item banks allow investigators and clinicians to measure perceptions of social attitudes, providing information that can guide individual interventions to reduce barriers and promote facilitators. Moderate correlations between the Social Attitude banks and PROMIS and Toolbox variables provide support for the measurement and theory of environmental influences on social health and participation.

Feasibility and Preliminary Efficacy of a Bright Light Intervention in Ovarian and Endometrial Cancer Survivors.

BACKGROUND: Cancer-related sleep disturbance is common and can adversely affect physical and mental health. Bright light (BL) therapy is a novel intervention that targets sleep by promoting circadian regulation. Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited. The present two-phase pilot study assessed the feasibility and preliminary intended effects of BL therapy on sleep in ovarian and endometrial cancer survivors, and explored biologic and chronobiologic factors that may underlie intervention effects. METHODS: In phase I, focus groups were conducted with 12 survivors and 9 gynecologic oncology clinicians to evaluate and gather feedback about the proposed study. In phase II, a pilot randomized controlled trial was conducted with 18 ovarian or endometrial cancer survivors who were randomized 1:1 to receive 45 min of BL or dim light (DL) for 4 weeks. Participants wore wrist actigraphs; completed sleep diaries and self-report questionnaires; and provided blood, saliva, and urine samples at baseline (T1), post-intervention (T2), and 3-month follow-up (T3). RESULTS: Study procedures were modified according to focus group results. Enrollment, retention, and adherence were all ≥ 80%. Mixed-model ANOVAs demonstrated that the number of nighttime awakenings per actigraphy, and sleep quality and depression per self-report, trended toward improvements in the BL condition compared to the DL condition. These variables improved from T1 to T2 before returning to baseline at T3. Effect sizes were generally medium to large. CONCLUSIONS: Study findings suggest that BL therapy is feasible among ovarian and endometrial cancer survivors. It may be an effective, non-pharmacological approach to reduce sleep disturbance and symptom burden in this population.

Symptom and needs assessment screening in oncology patients: Alternate outreach methods during COVID-19.

Patients with cancer are ideally screened for symptoms, including distress, using patient-reported outcome measures (PROMs). This initiative was developed to ensure patients without access to an electronic portal were screened for distress and related symptoms during the COVID-19 pandemic. Prior to the pandemic, these patients could complete screening in clinic. However, many visits transitioned to telehealth. We implemented a standardized telephone outreach process targeting patients without active electronic portal accounts to improve remote symptom monitoring. Outreach resulted in 172 completed screens, identifying 110 needs for 63 individuals. Twenty-eight patients completed patient portal enrollment. Outreach calls captured a higher percentage of Black patients (34%) and a higher percentage of 61-80 year olds (69%) compared to portal users. Telephone outreach during the pandemic captured data that otherwise would have been missed in elderly and minority patients without electronic patient portal access. Patient engagement is vital to the distress screening process.

The increasing value of eHealth in the delivery of patient-centred cancer care.

The increasing use of eHealth has ushered in a new era of patient-centred cancer care that moves beyond the traditional in-person care model to real-time, dynamic, and technology-assisted assessments and interventions. eHealth has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimised patient engagement across the cancer care continuum. In this Review, we provide a brief, narrative appraisal of the peer reviewed literature over the past 10 years related to the uses of patient-centred eHealth to improve cancer care delivery. These uses include the addressal of symptom management, health-related quality of life, and other patient-reported outcomes across cancer care. In addition, we discuss the challenges of, and opportunities for, accessibility, scalability, and implementation of these technologies, important areas for further development, and future research directions.

Implementing electronic health record-integrated screening of patient-reported symptoms and supportive care needs in a comprehensive cancer center.

BACKGROUND: Oncology practice can be enhanced by the integration of the assessment of patient-reported symptoms and concerns into the electronic health record (EHR) and clinical workflows. METHODS: Adult oncology outpatients (n = 6825) received 38,422 invitations to complete assessments through the EHR patient portal. Patient-Reported Outcomes Measurement Information System computer adaptive tests were administered to assess fatigue, pain interference, physical function, depression, and anxiety. Checklists identified psychosocial, nutritional, and informational needs. In real time, assessment results were populated in the EHR, and clinicians were notified of elevated symptoms and needs. RESULTS: In all, 3521 patients (51.6%) completed 8162 assessments; approximately 55% of the responding patients completed 2 or more within 32 months. Fatigue, pain, anxiety, and depression scores were comparable to those of the general population (approximately 5% of assessments triggered clinical alerts across those domains); mean scores indicated a lower level of physical function (with severe scores prompting alerts in nearly 5% of assessments). More than half of assessments triggered an alert based on patient endorsement of supportive care needs, with the majority of those being nutritional (41.82% of assessments). Patient endorsement of supportive care needs was associated with significantly higher anxiety, depression, fatigue, and pain interference scores and lower physical function scores. Patients who triggered clinical alerts tended to be younger and more recently diagnosed, to have greater comorbidities, and to be a racial/ethnic minority. Patients who triggered clinical alerts had more health care service encounters in the ensuing month. CONCLUSIONS: EHR integration facilitated the assessment and reporting of patient-reported symptoms and needs within routine oncology outpatient care.

What does risk of future cancer mean to breast cancer patients?

PURPOSE: Newly diagnosed breast cancer patients greatly overestimate their risk of developing contralateral breast cancer (CBC). Better understanding of patient conceptions of risk would facilitate doctor-patient communication and surgical decision making. In this mixed methods study, we prospectively examined breast cancer patients' perceived risk of future cancer and the reported factors that drove their risk perceptions. METHODS: Women age 21-60 diagnosed with breast cancer without a BRCA mutation or known distant metastases completed a study interview between surgical consult and surgical treatment. Participants completed a 12-item Perceived Risk Questionnaire, which assessed 10-year and lifetime risks of ipsilateral local recurrence, CBC, and distant recurrence. Patients provided qualitative explanations for their answers. RESULTS: Sixty-three patients completed study interviews (mean age 50.3). Participants were primarily White (85.7%) and 90.5% had attended college. Patients estimated their 10-year risk of CBC as 22.0%, nearly 4 times the established 10-year risk. Women attributed their risk perceptions to "gut feelings" about future cancer, even when women knew those feelings contradicted medically established risk. Perceptions of risk also reflected beliefs that cancer is random and that risk for local recurrence, CBC, and distant recurrence are the same. CONCLUSIONS: Our findings point to the need for novel ways of presenting factual information regarding both risk of recurrence and of new primary cancers, as well as the necessity of acknowledging cognitive and affective processes many patients use when conceptualizing risk. By differentiating women's intuitive feelings about risk from their knowledge of medically estimated risk, doctors can enhance informed decision making.

Cancer experiences and health-related quality of life among racial and ethnic minority survivors of young adult cancer: a mixed methods study.

PURPOSE: Young adult (YA) racial and ethnic minority survivors of cancer (diagnosed ages 18-39) experience significant disparities in health outcomes and survivorship compared to non-minorities of the same age. However, little is known about the survivorship experiences of this population. The purpose of this study is to explore the cancer experiences and health-related quality of life (HRQOL) among YA racial/ethnic minorities in an urban US city. METHODS: Racial and ethnic minority YA cancer survivors (0 to 5 years posttreatment) were recruited from a comprehensive cancer center using a purposive sampling approach. Participants (n = 31) completed semi-structured interviews, the FACT-G (physical, emotional, social well-being) and the FACIT-Sp (spiritual well-being). Mixed methods data were evaluated using thematic analysis and analysis of covariance (ANCOVA). RESULTS: The majority of survivors were women (65 %), single (52 %), and Hispanic (42 %). Across interviews, the most common themes were the following: "changes in perspective," "emotional impacts," "received support," and "no psychosocial changes." Other themes varied by racial/ethnic subgroups, including "treatment effects" (Hispanics), "behavior changes" (Blacks), and "appreciation for life" (Asians). ANCOVAs (controlling for gender and ECOG performance status scores) revealed that race/ethnicity had a significant main effect on emotional (P = 0.05), but not physical, social, or spiritual HRQOL (P > 0.05). CONCLUSIONS: Our findings suggest that minority YA cancer survivors report complex positive and negative experiences. In spite of poor health outcomes, survivors report experiencing growth and positive change due to cancer. Variations in experiences and HRQOL highlight the importance of assessing cultural background to tailor survivorship care among YA racial and ethnic minorities.

Measuring Access to Information and Technology: Environmental Factors Affecting Persons With Neurologic Disorders.

OBJECTIVE: To develop and validate a patient-reported measure of access to information and technology (AIT) for persons with spinal cord injury, stroke, or traumatic brain injury. DESIGN: A mixed-methods approach was used to develop items, refine them through cognitive interviews, and evaluate their psychometric properties. Item responses were evaluated with the Rasch rating scale model. Correlational and analysis-of-variance methods were used to evaluate construct validity. SETTING: Community-dwelling individuals participated in telephone interviews or traveled to the academic medical centers where this research took place. PARTICIPANTS: Individuals with a diagnosis of spinal cord injury, stroke, or traumatic brain injury (aged ≥18y, English speaking) participated in cognitive interviews (n=12 persons), field testing of the items (n=305 persons), and validation testing of the final set of items (n=604 persons). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A set of items to measure AIT for people with disabilities. RESULTS: A user-friendly multimedia touchscreen was used for self-administration of the items. A 23-item AIT measure demonstrated good evidence of internal consistency reliability, and content and construct validity. CONCLUSIONS: This new AIT measure will enable researchers and clinicians to determine to what extent environmental factors influence health outcomes and social participation in people with disabilities. The AIT measure could also provide disability advocates with more specific and detailed information about environmental factors to lobby for elimination of barriers.

Measuring Environmental Factors: Unique and Overlapping International Classification of Functioning, Disability and Health Coverage of 5 Instruments.

OBJECTIVES: To describe the unique and overlapping content of the newly developed Environmental Factors Item Banks (EFIB) and 7 legacy environmental factor instruments, and to evaluate the EFIB's construct validity by examining associations with legacy instruments. DESIGN: Cross-sectional, observational cohort. SETTING: Community. PARTICIPANTS: A sample of community-dwelling adults with stroke, spinal cord injury, and traumatic brain injury (N=568). INTERVENTIONS: None. MAIN OUTCOME MEASURES: EFIB covering domains of the built and natural environment; systems, services, and policies; social environment; and access to information and technology; the Craig Hospital Inventory of Environmental Factors (CHIEF) short form; the Facilitators and Barriers Survey/Mobility (FABS/M) short form; the Home and Community Environment Instrument (HACE); the Measure of the Quality of the Environment (MQE) short form; and 3 of the Patient Reported Outcomes Measurement Information System's (PROMIS) Quality of Social Support measures. RESULTS: The EFIB and legacy instruments assess most of the International Classification of Functioning, Disability and Health (ICF) environmental factors chapters, including chapter 1 (products and technology; 75 items corresponding to 11 codes), chapter 2 (natural environment and human-made changes; 31 items corresponding to 7 codes), chapter 3 (support and relationships; 74 items corresponding to 7 codes), chapter 4 (attitudes; 83 items corresponding to 8 codes), and chapter 5 (services, systems, and policies; 72 items corresponding to 16 codes). Construct validity is provided by moderate correlations between EFIB measures and the CHIEF, MQE barriers, HACE technology mobility, FABS/M community built features, and PROMIS item banks and by small correlations with other legacy instruments. Only 5 of the 66 legacy instrument correlation coefficients are moderate, suggesting they measure unique aspects of the environment, whereas all intra-EFIB correlations were at least moderate. CONCLUSIONS: The EFIB measures provide a brief and focused assessment of ICF environmental factor chapters. The pattern of correlations with legacy instruments provides initial evidence of construct validity.

Development of self-report measures of social attitudes that act as environmental barriers and facilitators for people with disabilities.

OBJECTIVE: To describe the development of new self-report measures of social attitudes that act as environmental facilitators or barriers to the participation of people with disabilities in society. DESIGN: A mixed-methods approach included a literature review; item classification, selection, and writing; cognitive interviews and field testing of participants with spinal cord injury (SCI), traumatic brain injury (TBI), or stroke; and rating scale analysis to evaluate initial psychometric properties. SETTING: General community. PARTICIPANTS: Individuals with SCI, TBI, or stroke participated in cognitive interviews (n=9); community residents with those same conditions participated in field testing (n=305). INTERVENTIONS: None. MAIN OUTCOME MEASURE: Self-report item pool of social attitudes that act as facilitators or barriers to people with disabilities participating in society. RESULTS: An interdisciplinary team of experts classified 710 existing social environment items into content areas and wrote 32 new items. Additional qualitative item review included item refinement and winnowing of the pool prior to cognitive interviews and field testing of 82 items. Field test data indicated that the pool satisfies a 1-parameter item response theory measurement model and would be appropriate for development into a calibrated item bank. CONCLUSIONS: Our qualitative item review process supported a social environment conceptual framework that includes both social support and social attitudes. We developed a new social attitudes self-report item pool. Calibration testing of that pool is underway with a larger sample to develop a social attitudes item bank for persons with disabilities.

Environmental barriers and supports to everyday participation: a qualitative insider perspective from people with disabilities.

OBJECTIVE: To describe environmental factors that influence participation of people with disabilities. DESIGN: Constant comparative, qualitative analyses of transcripts from 36 focus groups across 5 research projects. SETTING: Home, community, work, and social participation settings. PARTICIPANTS: Community-dwelling people (N=201) with diverse disabilities (primarily spinal cord injury, traumatic brain injury, and stroke) from 8 states. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Environmental barriers and supports to participation. RESULTS: We developed a conceptual framework to describe how environmental factors influence the participation of people with disabilities, highlighting 8 domains of environmental facilitators and barriers (built, natural, assistive technology, transportation, information and technology access, social support and attitudes, systems and policies, economics) and a transactional model showing the influence of environmental factors on participation at the micro (individual), mesa (community), and macro (societal) levels. Focus group data validated some International Classification of Functioning, Disability and Health environmental categories while also bringing unique factors (eg, information and technology access, economic quality of life) to the fore. Data were used to construct items to enable people with disabilities to assess the impact of environmental factors on everyday participation from their firsthand experience. CONCLUSIONS: Participants with disabilities voiced the need to evaluate the impact of the environment on their participation at the immediate, community, and societal levels. The results have implications for assessing environmental facilitators and barriers to participation within rehabilitation and community settings, evaluating outcomes of environmental interventions, and effecting system and policy changes to target environmental barriers that may result in societal participation disparities versus opportunities.

Environmental factors item development for persons with stroke, traumatic brain injury, and spinal cord injury.

OBJECTIVES: To describe methods used in operationalizing environmental factors; to describe the results of a research project to develop measures of environmental factors that affect participation; and to define an initial item set of facilitators and barriers to participation after stroke, traumatic brain injury, and spinal cord injury. DESIGN: Instrument development included an extensive literature review, item classification and selection, item writing, and cognitive testing following the approach of the Patient-Reported Outcomes Measurement Information System. SETTING: Community. PARTICIPANTS: Content area and outcome measurement experts (n=10) contributed to instrument development; individuals (n=200) with the target conditions participated in focus groups and in cognitive testing (n=15). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Environmental factor items were categorized in 6 domains: assistive technology; built and natural environment; social environment; services, systems, and policies; access to information and technology; and economic quality of life. RESULTS: We binned 2273 items across the 6 domains, winnowed this pool to 291 items for cognitive testing, and recommended 274 items for pilot data collection. CONCLUSIONS: Five of the 6 domains correspond closely to the International Classification of Functioning, Disability and Health taxonomy of environmental factors; the sixth domain, economic quality of life, reflects an important construct that reflects financial resources that affect participation. Testing with a new and larger sample is underway to evaluate reliability, validity, and sensitivity.

Health Literacy and Patient-Reported Outcomes: A Cross-Sectional Study of Underserved English- and Spanish-Speaking Patients With Type 2 Diabetes.

This study examined associations between patient characteristics, health behaviors, and health outcomes and explored the role of health literacy as a potential mediator of outcomes. English- and Spanish-speaking adults with Type 2 diabetes used a bilingual multimedia touchscreen to complete questionnaires. The behavioral model for vulnerable populations guided multivariable regression and mediation testing. Dependent variables were diabetes self-care, health status, and satisfaction with communication. Independent variables included sociodemographic and clinical characteristics, health literacy, health beliefs, and self-efficacy. Spanish speakers had lower health literacy and poorer physical, mental, and overall health compared to English speakers. Higher health literacy was associated with less social support for diet, fewer diet and medication barriers, younger age, higher diabetes knowledge, and talking with health care professionals to get diabetes information. In contrast to expectations, health literacy was not associated with diabetes self-care, health status, or satisfaction with communication, and it did not mediate the effects of other factors on these outcomes. Diabetes self-efficacy was significantly associated with health behaviors and outcomes. The association between Spanish language preference and poorer health was not mediated by this group's lower health literacy. Increasing health-related self-efficacy might be an important clinical strategy for improving outcomes in underserved patients with Type 2 diabetes.

Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls.

BACKGROUND: Young adults (YAs; ages 18-39 years) with cancer face interrupted developmental milestones and increased stressors that can adversely influence psychosocial adjustment. Transitioning from active treatment to posttreatment survivorship can be particularly challenging. The purpose of this study is to describe the health-related quality of life (HRQL) and psychological adaptation of YAs after treatment, relative to young adults without cancer. METHODS: Three cohorts of YAs of mixed cancer diagnoses (N = 120, 0-12 months after treatment; N = 102, 13-24 months after treatment; and N = 113, 25-60 months after treatment; combined M = 31.8 years old, combined sex = 68% women) and an age-, education-, sex-, and partner status-matched group of healthy control participants (HCs; N = 335) were recruited via an online research panel. All participants completed measures assessing demographic and clinical characteristics, HRQL (physical, emotional, social, and spiritual), and psychological adaptation (anxiety, depression, positive affect, posttraumatic growth). Measure content was slightly modified for applicability to HCs without a cancer history. RESULTS: Multivariate analysis of covariance found a significant main effect for group (YAs versus HCs) and a significant group-by-cohort interaction. YAs reported poorer physical (P = .005, d = .22) and emotional well-being (P = .011, d = .20) but better social well-being (P < .001, d = .49). YAs reported comparatively stable scores (P = .74) for posttraumatic growth compared to HCs, who reported greater posttraumatic growth across cohorts (P = .01, d = 16). CONCLUSIONS: Findings underscore the negative and positive sequelae for YAs and highlight the need for comprehensive assessment among YA survivors of cancer. A matched, HC group allows the HRQL and psychological adaptation of YAs to be placed in context, enabling a more precise determination of the impact of cancer on YAs.

Development and validation of the functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures.

PURPOSE: To develop and validate a new functional assessment of chronic illness therapy (FACIT) measure of satisfaction with treatment for chronic illnesses such as cancer and HIV/AIDS. METHODS: To define domains and generate items, a literature review informed creation of semi-structured interview guides for patients and an international expert panel of clinicians and researchers. Patients and experts also rated 15 areas of satisfaction for relevance. The final list of items underwent further refinement by the original expert panel and a new group of clinical experts. Items were tested in four studies (primarily lung cancer) and data were pooled for analysis. Exploratory and confirmatory factor analyses (CFA), and item response theory modeling were conducted to evaluate dimensionality. Internal consistency reliability and test-retest reliability were both evaluated. Validity was evaluated by correlating the FACIT subscale scores and measures of comparable concepts and by testing the scales' ability to distinguish people according to their overall treatment satisfaction. RESULTS: Two instruments were created: the FACIT TS-general (G), an overall evaluation of current treatment, and the FACIT TS-patient satisfaction (PS), a measure of patient satisfaction. CFA results were not optimal for a five-factor solution for PS. Internal consistency reliability met psychometric standards (≥0.70) for all PS subscales. Construct validity was established for the PS subscales: Physician Communication, Treatment Staff Communication, Technical Competence, Confidence and Trust, and Nurse Communication. CONCLUSIONS: The two instruments generated here offer a new way to assess several key dimensions of patient satisfaction with treatment, especially for people with lung cancer.

English-Spanish equivalence of the Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT).

Unbiased measurement instruments are needed to reliably estimate health literacy in diverse populations. The study aimed (a) to evaluate measurement equivalence of Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) and (b) to compare Health LiTT scores between English- and Spanish-speaking individuals. Health LiTT and several patient-reported outcome instruments were completed by adult patients receiving care for type 2 diabetes at a safety net clinic. English-Spanish measurement equivalence was evaluated with an item response theory approach to differential item functioning (DIF) detection and impact. Health LiTT scores were compared by language using multivariable linear regression. Approximately equal numbers of English-speaking patients (n=146) and Spanish-speaking patients (n=149) with type 2 diabetes were enrolled. English participants were primarily non-Hispanic Black (65%); all Spanish participants were Hispanic. Six Health LiTT items were flagged for DIF. The Pearson correlation between unadjusted and DIF adjusted scores was 0.995; the mean difference of individual difference scores was 0.0005 (SD=0.0888). After adjusting for predisposing characteristics, enabling resources and need for care, Health LiTT scores were comparable for Spanish-speaking individuals versus English-speaking individuals. The effect of DIF items on Health LiTT scores appeared to be trivial. English-Spanish equivalence of Health LiTT will permit researchers to determine the independent effects of limited English proficiency and limited literacy.