IU Indianapolis ScholarWorks :: Browsing by Author "Cella, David"

Browsing by Author "Cella, David"

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Assessing Psychological Well-Being: Self-Report Instruments for the NIH Toolbox
(Springer International Publishing, 2014-02) Salsman, John M.; Lai, Jin-Shei; Hendrie, Hugh C.; Butt, Zeeshan; Zill, Nicholas; Pilkonis, Paul A.; Peterson, Christopher; Stoney, Catherine M.; Brouwers, Pim; Cella, David; Department of Medicine, IU School of Medicine
Objective— Psychological well-being (PWB) has a significant relationship with physical and mental health. As part of the NIH Toolbox for the Assessment of Neurological and Behavioral Function, we developed self-report item banks and short forms to assess PWB. Study Design and Setting— Expert feedback and literature review informed the selection of PWB concepts and the development of item pools for Positive Affect, Life Satisfaction, and Meaning and Purpose. Items were tested with a community-dwelling U.S. internet panel sample of adults aged 18 and above (N=552). Classical and item response theory (IRT) approaches were used to evaluate unidimensionality, fit of items to the overall measure, and calibrations of those items, including differential item function (DIF). Results— IRT-calibrated item banks were produced for Positive Affect (34 items), Life Satisfaction (16 items), and Meaning and Purpose (18 items). Their psychometric properties were supported based on results of factor analysis, fit statistics, and DIF evaluation. All banks measured the concepts precisely (reliability ≥0.90) for more than 98% of participants. Conclusion— These adult scales and item banks for PWB provide the flexibility, efficiency, and precision necessary to promote future epidemiological, observational, and intervention research on the relationship of PWB with physical and mental health.
Assessment of Racial Disparity in Survival Outcomes for Early Hormone Receptor–Positive Breast Cancer After Adjusting for Insurance Status and Neighborhood Deprivation
(American Medical Association, 2022) Sadigh, Gelareh; Gray, Robert J.; Sparano, Joseph A.; Yanez, Betina; Garcoa, Sofia F.; Timsina, Lava R.; Obeng-Gyasi, Samilia; Gareen, Ilana; Sledge, George W.; Whelan, Timothy J.; Cella, David; Wagner, Lynne I.; Carlos, Ruth C.; Surgery, School of Medicine
Importance: Racial disparities in survival outcomes among Black women with hormone receptor-positive breast cancer have been reported. However, the association between individual-level and neighborhood-level social determinants of health on such disparities has not been well studied. Objective: To evaluate the association between race and clinical outcomes (ie, relapse-free interval and overall survival) adjusting for individual insurance coverage and neighborhood deprivation index (NDI), measured using zip code of residence, in women with breast cancer. Design, setting, and participants: This was a post hoc analysis of 9719 women with breast cancer in the Trial Assigning Individualized Options for Treatment, a randomized clinical trial conducted from April 7, 2006, to October 6, 2010. All participants received a diagnosis of hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer. The present data analysis was conducted from April 1 to October 22, 2021. Main outcomes and measures: A multivariate model was developed to evaluate the association between race and relapse-free interval and overall survival adjusting for insurance and NDI level at study entry, early discontinuation of endocrine therapy 4 years after initiation, and clinicopathologic characteristics of cancer. Median follow-up for clinical outcomes was 96 months. Results: A total of 9719 women (4.2% [n = 405] Asian; 7.1% [n = 693] Black; 84.3% [n = 8189] White; 4.4% [n = 403] others/not specified) were included; 9.1% of included women [n = 889] were Hispanic or Latino. Median (SD) age was 56 (9.2) years. In multivariate models, Black race compared with White race was associated with statistically significant shorter relapse-free interval (hazard ratio [HR], 1.39; 95% CI, 1.05-1.84; P = .02) and overall survival (HR, 1.49; 95% CI, 1.10-2.99; P = .009), adjusting for insurance and NDI level at study entry and other factors. Although uninsured status was not associated with clinical outcomes, patients with Medicare (HR, 1.30; 95% CI, 1.01-1.68; P = .04) and Medicaid (HR, 1.44; 95% CI, 1.01-2.05; P = .05) had shorter overall survival compared with those with private insurance. Participants living in neighborhoods in the highest NDI quartile experienced shorter overall survival compared with those in the lowest quartile (HR, 1.34; 95% CI, 1.01-1.77; P = .04), regardless of self-identified race. Conclusions and relevance: The findings of this post hoc analysis of a randomized clinical trial suggest that Black women with breast cancer have significantly shorter relapse-free interval and overall survival compared with White women. Early discontinuation of endocrine therapy, clinicopathologic characteristics, insurance coverage, and NDI do not fully explain the observed disparity.
Association of cognitive impairment and breast cancer survivorship on quality of life in younger breast cancer survivors
(Springer, 2021) Von Ah, Diane; Crouch, Adele D.; Monahan, Patrick O.; Stump, Timothy E; Unverzagt, Frederick W.; Storey, Susan; Cohee, Andrea A.; Cella, David; Champion, Victoria L.
Purpose Younger breast cancer survivors (BCS) often report cognitive impairment and poor quality of life (QoL), which could be interrelated. The purpose of this study was to examine the association of cognitive impairment and breast cancer status (BCS versus healthy control (HC)), with QoL, which included psychological (depressive symptoms, well-being, perceived stress, and personal growth) and physical well-being (physical functioning and fatigue). Methods Four hundred ninety-eight BCS (≤45 years at diagnosis) who were 3 to 8 years post-chemotherapy treatment and 394 HC completed subjective questionnaires and a one-time neuropsychological assessment, including tests of attention, memory, processing speed, and verbal fluency. For each test, cognitive impairment was defined as scoring 1.5 and 2.0 standard deviations below the mean of the HC group. Separate linear regression models for each outcome were ran controlling for known covariates. Results BCS reported significantly more memory problems than HC (p < 0.0001), with up to 23% having significant impairment. Cognitive performance did not differ significantly between BCS and HCs. BCS vs. HCs had greater depression and fatigue, yet more personal growth. Objective and subjective cognitive impairment were significantly related to greater depressive symptoms and perceived stress and lower well-being and physical functioning; whereas, objective impairment was related to less personal growth and subjective impairment was related to greater fatigue. Conclusions Younger BCS report significant cognitive impairment years after treatment which may relate to greater decrements in QoL.
Avoidant Coping and Self-efficacy Mediate Relationships between Perceived Social Constraints and Symptoms among Long-term Breast Cancer Survivors
(Wiley, 2016) Adams, Rebecca N.; Mosher, Catherine E.; Cohee, Andrea A.; Stump, Timothy E.; Monahan, Patrick O.; Sledge, George W., Jr; Cella, David; Champion, Victoria L.; Department of Psychology, School of Science
Objective Many breast cancer survivors feel constrained in discussing their cancer experience with others. Limited evidence suggests that social constraints (e.g., avoidance and criticism) from loved ones may negatively impact breast cancer survivors' global health, but research has yet to examine relationships between social constraints and common physical symptoms. Informed by social cognitive processing theory, this study examined whether perceived social constraints from partners and healthcare providers (HCPs) were associated with fatigue, sleep disturbance, and attentional functioning among long-term breast cancer survivors (N = 1052). In addition, avoidant coping and self-efficacy for symptom management were examined as potential mediators of these relationships. Methods Long-term breast cancer survivors (mean years since diagnosis = 6) completed questionnaires assessing social constraints from partners and HCPs, avoidant coping, self-efficacy for symptom management, and symptoms (i.e., fatigue, sleep disturbance, and attentional functioning). Structural equation modeling was used to evaluate the hypothesized relationships among variables in two models: one focused on social constraints from partners and one focused on social constraints from HCPs. Results Both models demonstrated good fit. Consistent with theory and prior research, greater social constraints from both partners and HCPs were associated with greater symptom burden (i.e., greater fatigue and sleep disturbance, poorer attentional functioning). In addition, all relationships were mediated by avoidant coping and self-efficacy for symptom management. Conclusions Findings are consistent with social cognitive processing theory and suggest that symptom management interventions may be enhanced by addressing the impact of social constraints from survivors' partners and HCPs on their coping and self-efficacy.
Barriers and Facilitators to Implementing Patient-Reported Outcome Monitoring in Gastrointestinal Surgery
(Elsevier, 2023) Iroz, Cassandra B.; Johnson, Julie K.; Ager, Meagan S.; Joung, Rachel Hae-Soo; Brajcich, Brian C.; Cella, David; Franklin, Patricia D.; Holl, Jane L.; Bilimoria, Karl Y.; Merkow, Ryan P.; Surgery, School of Medicine
Introduction: More than 30% of patients experience complications after major gastrointestinal (GI) surgery, many of which occur after discharge when patients and families must assume responsibility for monitoring. Patient-reported outcomes (PROs) have been proposed as a tool for remote monitoring to identify deviations in recovery, and recognize and manage complications earlier. This study's objective was to characterize barriers and facilitators to the use of PROs as a patient monitoring tool following GI surgery. Methods: We conducted semistructured interviews with GI surgery patients and clinicians (surgeons, nurses, and advanced practitioners). Patients and clinicians were asked to describe their experience using a PRO monitoring system in three surgical oncology clinics. Using a phenomenological approach, research team dyads independently coded the transcripts using an inductively developed codebook and the constant comparative approach with differences reconciled by consensus. Results: Ten patients and five clinicians participated in the interviews. We identified four overarching themes related to functionality, workflow, meaningfulness, and actionability. Functionality refers to barriers faced by clinicians and patients in using the PRO technology. Workflow represents problematic integration of PROs into the clinical workflow and need for setting expectations with patients. Meaningfulness refers to lack of patient and clinician understanding of the impact of PROs on patient care. Finally, actionability reflects barriers to follow-up and practical use of PRO data. Conclusions: While use of PRO systems for postoperative patient monitoring have expanded, significant barriers persist for both patients and clinicians. Implementation enhancements are needed to optimize functionality, workflow, meaningfulness, and actionability.
Breast Cancer Patients’ Insurance Status and Residence Zip Code Correlates with Early Discontinuation of Endocrine Therapy: Analysis of ECOG-ACRIN TAILORx Trial
(Wiley, 2021) Sadigh, Gelareh; Gray, Robert J.; Sparano, Joseph A.; Yanez, Betina; Garcia, Sofia F.; Timsina, Lava R.; Sledge, George W.; Cella, David; Wagner, Lynne I.; Carlos, Ruth C.; Surgery, School of Medicine
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.
Cognitive Dysfunction Prevalence and Associated Factors in Older Breast Cancer Survivors
(Elsevier, 2022) Crouch, Adele; Champion, Victoria L.; Unverzagt, Frederick W.; Pressler, Susan J.; Huber, Lesa; Moser, Lyndsi R.; Cella, David; Von Ah, Diane; School of Nursing
Objectives: The purpose of this study was to examine the prevalence and factors associated with objective and subjective cognitive dysfunction in older breast cancer survivors (BCS). Materials and methods: This cross-sectional descriptive study leveraged previously collected data from older BCS (n = 335). Separate linear regression models were used to determine relationships between demographic factors (age, education), medical factors (comorbidities), disease factors (time since diagnosis, cancer stage), cancer-related symptoms (depressive symptoms, anxiety, fatigue, sleep disturbance) and cognitive dysfunction measures, including objective learning, delayed recall, attention, executive function-working memory, verbal fluency and subjective attentional function. Results: Cognitive dysfunction was prevalent with up to 18.6% of older BCS experiencing mild-moderate dysfunction (1.5 standard deviations below mean of non-cancer controls) in at least one cognitive domain. Poor to moderate subjective attentional function was reported by 26% of older BCS. More depressive symptoms were significantly related to poorer cognitive function including learning (p < .01), delayed recall (p < .05), verbal fluency (p < .001), and subjective attentional function (p < .001) but not attention and executive function-working memory. Age, education, anxiety, and fatigue were also negatively associated with cognitive function in some models (p < .05-0.001). Conclusion: Cognitive dysfunction is common among older BCS and depressive symptoms, anxiety, and fatigue are related factors. Importantly, depressive symptoms were not only related to self-report, but also to cognitive performance. Healthcare providers should be aware of and assess for related factors and cognitive dysfunction itself in older BCS even years after diagnosis and treatment thorough geriatric assessment. Future longitudinal research is needed to discern these relationships.
A cohort study of quality of life in partners of young breast cancer survivors compared to partners of healthy controls
(Springer, 2020-03-06) Cohee, Andrea A.; Storey, Susan; Winger, Joseph; Cella, David; Stump, Timothy; Monahan, Patrick; Champion, Victoria
Background Partners of young breast cancer survivors (BCS) are at increased risk for deficits in quality of life (QoL). To intervene effectively, it is important to understand how the breast cancer experience impacts partners. The purpose of this study was to compare QoL between partners of young BCS and partners of healthy acquaintance controls. Methods Partners of young BCS (3–8 years post treatment and ≤ 45 years old at diagnosis) and partners of age-matched healthy acquaintance controls completed questionnaires on overall, physical (physical function, sexual difficulty), social (personal resources, sexual enjoyment, marital satisfaction, partner social support, social constraints, parenting satisfaction), psychological (depressive symptoms), and spiritual (behaviors, beliefs, and activities) QoL. Analyses included descriptive statistics and one-way ANOVA to compare partner groups on all study variables. Results Although partners of young BCS (n = 227) reported fewer social constraints (p < .001), they reported lower overall QoL (p < .001), fewer personal resources (p < .001), more sexual difficulty (p = .019), less sexual enjoyment (p = .002), less marital satisfaction (p = .019), more depressive symptoms (p = .024), and fewer spiritual behaviors (p < .001), beliefs (p = .001) and activities (p = .003) compared to partners of healthy acquaintance controls (n = 170). Additional analysis showed that perceptions that the relationship changed for the better since cancer, social constraints, partner social support, and depression predicted marital satisfaction among partners of young BCS. Conclusions Partners of young BCS are at risk for poorer overall, physical, social, psychological, and spiritual QoL compared to partners of healthy women. Interventions targeting QoL domains may enable partners to effectively support their partner and improve their QoL.
Comparison of younger and older breast cancer survivors and age-matched controls on specific and overall quality of life domains
(Wiley, 2014-08) Champion, Victoria L.; Wagner, Lynne I.; Monahan, Patrick O.; Daggy, Joanne; Smith, Lisa; Cohee, Andrea A.; Ziner, Kim W.; Haase, Joan E.; Miller, Kathy; Pradhan, Kamnesh; Unverzagt, Frederick W.; Cella, David; Ansari, Bilal; Sledge, George W. Jr.; Nursing, School of
BACKGROUND: Younger survivors (YS) of breast cancer often report more survivorship symptoms such as fatigue, depression, sexual difficulty, and cognitive problems than older survivors (OS). This study sought to determine the effect of breast cancer and age at diagnosis on quality of life (QoL) by comparing 3 groups: 1) YS diagnosed at age 45 years or before, 2) OS diagnosed between 55 and 70, and 3) for the YSs, age-matched controls (AC) of women not diagnosed with breast cancer. METHODS: Using a large Eastern Cooperative Oncology Group (ECOG) database, 505 YS were recruited who were aged 45 years or younger when diagnosed and 622 OS diagnosed at 55 to 70 years of age. YS, OS, and AC were compared on physical, psychological, social, spiritual, and overall QoL variables. RESULTS: Compared to both AC and to OS, YS reported more depressive symptoms (P = .005) and fatigue (P < .001), poorer self-reported attention function (P < .001), and poorer sexual function (P < .001) than either comparison group. However, YS also reported a greater sense of personal growth (P < .001) and perceived less social constraint (P < .001) from their partner than AC. CONCLUSIONS: YS reported worse functioning than AC relative to depression, fatigue, attention, sexual function, and spirituality. Perhaps even more important, YS fared worse than both AC and OS on body image, anxiety, sleep, marital satisfaction, and fear of recurrence, indicating that YS are at greater risk for long-term QoL problems than survivors diagnosed at a later age.
Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)
(American Society of Clinical Oncology, 2022) Khan, Seema A.; Zhao, Fengmin; Goldstein, Lori J.; Cella, David; Basik, Mark; Golshan, Mehra; Julian, Thomas B.; Pockaj, Barbara A.; Lee, Christine A.; Razaq, Wajeeha; Sparano, Joseph A.; Babiera, Gildy V.; Dy, Irene A.; Jain, Sarika; Silverman, Paula; Fisher, Carla S.; Tevaarwerk, Amye J.; Wagner, Lynne I.; Sledge, George W.; Surgery, School of Medicine
Purpose: Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results. Methods: Women presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments. Results: Of 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio = 1.11; 90% CI, 0.82 to 1.52; P = .57). The median OS was 53.1 months (95% CI, 47.9 to not estimable) in the systemic therapy arm and 54.9 months (95% CI, 46.7 to not estimable) in the locoregional therapy arm. Locoregional progression was less frequent in those randomly assigned to locoregional therapy (3-year rate: 16.3% v 39.8%; P < .001). Quality-of-life measures were largely similar between arms. Conclusion: Early locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life.

Browsing by Author "Cella, David"

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