Browsing by Author "Sepucha, Karen"

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    A randomized controlled trial of an online health tool about Down syndrome
    (Elsevier, 2021) Chung, Jeanhee; Donelan, Karen; Macklin, Eric A.; Schwartz, Alison; Elsharkawi, Ibrahim; Torres, Amy; Hsieh, Yichuan Grace; Parker, Holly; Lorenz, Stephen; Patsiogiannis, Vasiliki; Santoro, Stephanie L.; Wylie, Mark; Clarke, Lloyd; Estey, Greg; Baker, Sandra; Bauer, Patricia E.; Bull, Marilyn; Chicoine, Brian; Cullen, Sarah; Frey-Vogel, Ariel; Gallagher, Maureen; Hasan, Reem; Lamb, Ashley; Majewski, Lisa; Mast, Jawanda; Riddell, Travis; Sepucha, Karen; Skavlem, Melissa; Skotko, Brian G.; Pediatrics, School of Medicine
    Purpose: We sought to determine if a novel online health tool, called Down Syndrome Clinic to You (DSC2U), could improve adherence to national Down syndrome (DS) guidelines. We also sought to determine if primary care providers (PCPs) and caregivers are satisfied with this personalized online health tool. Methods: In a national, randomized controlled trial of 230 caregivers who had children or dependents with DS without access to a DS specialist, 117 were randomized to receive DSC2U and 113 to receive usual care. The primary outcome was adherence to five health evaluations indicated by national guidelines for DS. DSC2U is completed electronically, in all mobile settings, by caregivers at home. The outputs-personalized checklists-are used during annual wellness visits with the patient's PCP. Results: A total of 213 participants completed a 7-month follow-up evaluation. In the intention-to-treat analysis, the intervention group had a 1.6-fold increase in the number of indicated evaluations that were recommended by the primary care provider or completed compared with controls. Both caregivers and PCPs reported high levels of satisfaction with DSC2U. Conclusions: DSC2U improved adherence to the national DS health-care guidelines with a novel modality that was highly valued by both caregivers and PCPs.
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    Quality of Life Following Receipt of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node–Positive and High-Risk Lymph Node–Negative Breast Cancer
    (American Medical Association, 2022-02-01) Rosenberg, Shoshana M.; O'Neill, Anne; Sepucha, Karen; Miller, Kathy D.; Dang, Chau T.; Northfelt, Donald W.; Sledge, George W.; Schneider, Bryan P.; Partridge, Ann H.; Medicine, School of Medicine
    Importance: Breast cancer treatment can impact not only short-term health but may also affect longer-term quality of life (QOL). Objective: To describe and evaluate factors associated with diminished QOL following completion of active treatment. Design, setting, and participants: This was a secondary analysis of a randomized clinical trial included patients with lymph node-positive or high-risk lymph node-negative breast cancer who had undergone definitive surgery and were enrolled in ECOG-ACRIN E5103, a multisite phase 3 trial. A survey was administered 18 months after enrollment to patients enrolled between January and June 2010. Final analysis of the data took place from March to December 2021. Interventions: Patients received adjuvant doxorubicin, cyclophosphamide, and paclitaxel with either bevacizumab or placebo. Main outcomes and measures: QOL and health status assessed with the EuroQol 5-Dimension 3-Levels (EQ-5D-3L), EQ-visual analog scale (EQ-VAS), and the Functional Assessment of Cancer Therapy-Breast Cancer, with arm subscale (FACT-B+4). Groups were compared by Fisher exact test, Wilcoxon rank sum, or Kruskal-Wallis test. Multivariable linear regression was used to assess factors independently associated with FACT-B scores. Results: Data at 18 months were available from 455 of 519 patients (87.7%) enrolled in the trial. Median (range) age at enrollment was 52 (25-76) years. No differences in QOL (median [range] FACT-B scores: group A, 123 [67-146]; group B, 114 [54-148]; group C, 117 [42-148]; P = .23) or health status (median [range] EQ-5D-3L index scores: group A, 0.83 [0.28-1.00]; group B, 0.83 [0.20-1.00]; group C, 0.83 [0.17-1.00], P = .80; median EQ-VAS: group A, 85 [20-100]; group B, 85 [0-100]; group C, 85 [0-100]; P = .79) were observed across treatment groups; results for subsequent analyses were therefore reported irrespective of primary treatment. Overall, half of patients (258 of 444 [58%]) reported at least some pain or discomfort; 170 (38%) reported symptoms of anxiety or depression. In multivariable analyses, mastectomy with radiation (vs breast conserving surgery) and Asian, Black, or American Indian or Alaska Native race (vs White race) were associated with lower QOL (mastectomy with radiation: coefficient: -5.5; 95% CI, -10.1 to -0.9; Asian, Black, or American Indian or Alaska Native race: coefficient: -7.3; 95% CI, -13.2, -1.4). Conclusions and relevance: In this study, the addition of bevacizumab to chemotherapy was not negatively associated with QOL at 18 months. A substantial proportion of participants reported problems related to pain or discomfort and anxiety or depression, demonstrating persistent consequences for physical and psychosocial well-being in this heavily treated population. Many problems reported are amenable to intervention, underscoring the need for timely referral to supportive resources, especially for women of color and those who have more extensive local therapy.