Browsing by Author "Perkins, Susan M."
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Item A co-designed, community-based intensive health behavior intervention promotes participation and engagement in youth with risk factors for type 2 diabetes(Frontiers Media, 2023-12-01) Pike, Julie M.; Haberlin-Pittz, Kathryn M.; Alharbi, Basmah S.; Perkins, Susan M.; Hannon, Tamara S.; Pediatrics, School of MedicineBackground: Obesity among youth (children and adolescents) is associated with increased risk for youth-onset type 2 diabetes. Lifestyle change can delay or prevent the development of type 2 diabetes, yet real-world implementation of health behavior recommendations is challenging. We previously engaged youth with risk factors for type 2 diabetes, their caregivers, and professionals in a human-centered design study to co-design a lifestyle change program. Here we report the outcomes for this 16-week co-designed lifestyle change program for youth at risk for T2D and their caregivers. Research design and methods: This single-arm family-based cohort study included youth aged 7-18 years, with BMI ≥85th percentile (overweight or obese) and at least one additional risk factor for type 2 diabetes, and their caregivers. Clinical (BMI, HbA1c), self-reported physical activity, and quality of life outcomes were evaluated at baseline (B), post-intervention (M4), and 1 year (M12) following the intervention. Results: Seventy-eight youth (mean age 12.4 ± 2.7y, 67% female, 37.8% white) and 65 caregivers were included in the data analysis. Youth baseline BMI z-scores (2.26 ± 0.47) and HbA1c (5.3 ± 0.3) were unchanged at follow up time points [BMI z-scores M4 (2.25 ± 0.52), M12 (2.16 ± 0.58), p-value 0.46], [HbA1c M4 (5.3 ± 0.3), M12 (5.2 ± 0.3), p-value (0.04)]. Youth reported increased physical activity at M4 (p = 0.004), but not at M12. Youth quality of life scores increased at M12 (p=0.01). Families who attended at least one session (n=41) attended an average of 9 out of 16 sessions, and 37 percent of families attended 13 or more sessions. Conclusion: A co-designed, community-based lifestyle intervention promotes increased physical activity, improved quality of life, maintenance of BMI z-scores and HbA1c, and engagement in youth with risk factors for T2D.Item A phase 1 study of combined guadecitabine and cisplatin in platinum refractory germ cell cancer(Wiley, 2021) Albany, Costantine; Fazal, Zeeshan; Singh, Ratnakar; Bikorimana, Emmanuel; Adra, Nabil; Hanna, Nasser H.; Einhorn, Lawrence H.; Perkins, Susan M.; Sandusky, George E.; Christensen, Brock C.; Keer, Harold; Fang, Fang; Nephew, Kenneth P.; Spinella, Michael J.; Medicine, School of MedicinePurpose: Germ cell tumors (GCTs) are cured with therapy based on cisplatin, although a clinically significant number of patients are refractory and die of progressive disease. Based on preclinical studies indicating that refractory testicular GCTs are hypersensitive to hypomethylating agents (HMAs), we conducted a phase I trial combining the next-generation HMA guadecitabine (SGI-110) with cisplatin in recurrent, cisplatin-resistant GCT patients. Methods: Patients with metastatic GCTs were treated for five consecutive days with guadecitabine followed by cisplatin on day 8, for a 28-day cycle for up to six cycles. The primary endpoint was safety and toxicity including dose-limiting toxicity (DLT) and maximum tolerated dose (MTD). Results: The number of patients enrolled was 14. The majority of patients were heavily pretreated. MTD was determined to be 30 mg/m2 guadecitabine followed by 100 mg/m2 cisplatin. The major DLTs were neutropenia and thrombocytopenia. Three patients had partial responses by RECIST criteria, two of these patients, including one with primary mediastinal disease, completed the study and qualified as complete responses by serum tumor marker criteria with sustained remissions of 5 and 13 months and survival of 16 and 26 months, respectively. The overall response rate was 23%. Three patients also had stable disease indicating a clinical benefit rate of 46%. Conclusions: The combination of guadecitabine and cisplatin was tolerable and demonstrated activity in patients with platinum refractory germ cell cancer.Item A phase II study evaluating safety and efficacy of niraparib in patients with previously treated homologous recombination defective metastatic esophageal/gastroesophageal junction/proximal gastric adenocarcinoma(Frontiers Media, 2024-11-21) Khalid, Ahmed Bilal; Fountzilas, Christos; Burney, Heather N.; Mamdani, Hirva; Schneider, Bryan P.; Fausel, Christopher; Perkins, Susan M.; Jalal, Shadia; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthIntroduction: Esophageal adenocarcinoma (EAC) remains a devastating disease and second line treatment options in the metastatic space are limited. Homologous recombination (HR) defects have been described in EAC in up to 40% of patients. Poly (ADP-ribose) polymerase (PARP)1 and PARP2 inhibitors have shown efficacy in HR defective prostate and ovarian cancers. Here, we describe the activity of the PARP inhibitor niraparib in metastatic EAC with HR defects. Methods: In this single arm Simon two-stage Phase II study, we assessed the safety and efficacy of niraparib in patients with metastatic EAC previously treated with platinum containing chemotherapy harboring defective HR. Defective HR was defined as deleterious alterations in the following HR genes: BRCA1/2, PALB2, ATM, BARD1, BRIP1, CDK12, CHEK2, FANCA, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, NBN, ARID1A and GEN1. Results: 14 patients were enrolled in this study. The trial was stopped early due to slow accrual. 3 patients did not have post-treatment scans because of rapid clinical decline. The overall response rate (ORR) (95% exact CI) was 0/11 = 0% (0%, 28.49%). The disease control rate (DCR) (95% exact CI) was 2/11 = 18.2% (2.3%, 51.8%). The median PFS was 1.8 months (95% CI = 1.0-3.7). The median OS for evaluable patients was 6.6 months (95% CI =2.7-11.4) and 5.7 months for all patients (95% CI =2.7-10.1). The most common adverse events seen were anemia, fatigue, and thrombocytopenia. Conclusion: In patients with metastatic EAC, single agent niraparib as second line therapy is not an effective option.Item A Phase II Trial of Adjuvant Durvalumab Following Trimodality Therapy for Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma: A Big Ten Cancer Research Consortium Study(Frontiers Media, 2021-09-17) Mamdani, Hirva; Schneider, Bryan; Perkins, Susan M.; Burney, Heather N.; Kasi, Pashtoon Murtaza; Abushahin, Laith I.; Birdas, Thomas; Kesler, Kenneth; Watkins, Tracy M.; Badve, Sunil S.; Radovich, Milan; Jalal, Shadia I.; Surgery, School of MedicineBackground: Most patients with resectable locally advanced esophageal and gastroesophageal junction (GEJ) adenocarcinoma (AC) receive concurrent chemoradiation (CRT) followed by esophagectomy. The majority of patients do not achieve pathologic complete response (pCR) with neoadjuvant CRT, and the relapse rate is high among these patients. Methods: We conducted a phase II study (ClinicalTrials.gov Identifier: NCT02639065) evaluating the efficacy and safety of PD-L1 inhibitor durvalumab in patients with locally advanced esophageal and GEJ AC who have undergone neoadjuvant CRT followed by R0 resection with evidence of persistent residual disease in the surgical specimen. Patients received durvalumab 1500 mg IV every 4 weeks for up to 1 year. The primary endpoint was 1-year relapse free survival (RFS). Secondary endpoint was safety and tolerability of durvalumab following trimodality therapy. Exploratory endpoints included correlation of RFS with PD-L1 expression, HER-2 expression, and tumor immune cell population. Results: Thirty-seven patients were enrolled. The majority (64.9%) had pathologically positive lymph nodes. The most common treatment related adverse events were fatigue (27%), diarrhea (18.9%), arthralgia (16.2%), nausea (16.2%), pruritus (16.2%), cough (10.8%), and increase in AST/ALT/bilirubin (10.8%). Three (8.1%) patients developed grade 3 immune mediated adverse events. One-year RFS was 73% (95% CI, 56-84%) with median RFS of 21 months (95% CI, 14-40.4 months). Patients with GEJ AC had a trend toward superior 1-year RFS compared to those with esophageal AC (83% vs. 63%, p = 0.1534). There was a numerical trend toward superior 1-year RFS among patients with PD-L1 positive disease compared to those with PD-L1 negative disease, using CPS of ≥10 (100% vs. 66.7%, p = 0.1551) and ≥1 (84.2% vs. 61.1%, p = 0.1510) cutoffs. A higher relative proportion of M2 macrophages and CD4 memory activated T cells was associated with improved RFS (HR = 0.16; 95% CI, 0.05-0.59; p = 0.0053; and HR = 0.37; 95% CI, 0.15-0.93, p = 0.0351, respectively). Conclusions: Adjuvant durvalumab in patients with residual disease in the surgical specimen following trimodality therapy for locally advanced esophageal and GEJ AC led to clinically meaningful improvement in 1-year RFS compared to historical control rate. Higher PD-L1 expression may have a correlation with the efficacy of durvalumab in this setting. Higher proportion of M2 macrophages and CD4 memory activated T cells was associated with superior RFS.Item A pilot study protocol of a relational coordination training intervention among healthcare professionals in an Army medical center(Springer Nature, 2025-03-04) House, Sherita; Perkins, Susan M.; Miller, Melissa; Taylor‑Clark, Tanekkia; Newhouse, Robin; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthBackground: As patient care becomes more complex, high-quality communication and relationships among healthcare professionals are critical to coordinating care. Relational coordination (RC), a process of high-quality communication supported by shared goals, shared knowledge, and mutual respect, is positively associated with better patient (e.g., quality of care) and staff (e.g., job satisfaction, and retention) outcomes. A few researchers have found that communication skills training improves RC in civilian hospitals. However, researchers have not tested the feasibility of conducting communication skills training based on the RC framework among healthcare professionals in military hospitals. To address this gap, we propose conducting an RC training intervention in a military hospital. The primary aim of the proposed pilot study is to determine the feasibility (e.g., recruitment, retention, and completion rates) of conducting an RC training intervention in an Army medical center. The secondary aim is to explore the acceptability and usability of the RC training intervention. We will also explore changes in RC, quality of care, job satisfaction, and intent to stay among participants following the RC training intervention. Methods: A single-group feasibility study will be conducted among nurses and physicians from three units (intensive care unit, medical-surgical, and labor and delivery unit). A convenience sample of licensed practical nurses (LPNs), registered nurses (RNs), resident physicians, and physicians from the participating units will be invited to complete a 1-h RC training intervention once a month for 3 months. Participants will complete RC, quality of care, job satisfaction, and intent to stay measures at baseline and 2 weeks after each RC training intervention session. To assess the feasibility of conducting an RC training intervention, we will examine recruitment/retention rates, intervention session completion rates, and survey measure completion rates. Acceptability will be assessed qualitatively through focus group interviews, and results will be used to refine the intervention and determine if the selected measures align with participant experiences. For our secondary aim, we will explore the acceptability of the RC training intervention through focus group interviews. We will also explore changes in outcome measures using descriptive statistics with 95% confidence intervals. Discussion: Findings will establish the feasibility and acceptability of conducting an RC intervention in a military hospital and inform refinement of the intervention and study procedures prior to conducting a larger randomized controlled trial to establish efficacy.Item Active Music Engagement and Cortisol as an Acute Stress Biomarker in Young Hematopoietic Stem Cell Transplant Patients and Caregivers: Results of a Single Case Design Pilot Study(Frontiers in Psychology, 2020-11) Holochwost, Steven J.; Robb, Sheri L.; Henley, Amanda K.; Stegenga, Kristin; Perkins, Susan M.; Russ, Kristen A.; Jacob, Seethal A.; Delgado, David; Haase, Joan E.; Krater, Caitlin M.; Medicine, School of MedicineThis paper reports the results of a single case design pilot study of a music therapy intervention (the Active Music Engagement, or AME) for young children undergoing hematopoietic stem cell transplantation (HCST) and their caregivers. The primary aims of the study were to determine feasibility/acceptability of the AME intervention protocol and data collection in the context of HCST. Secondary aims were to examine caregivers’ perceptions of the benefit of AME and whether there were changes in child and caregiver cortisol levels relative to the AME intervention. Results indicated that the AME could be implemented in this context and that data could be collected, though the collection of salivary cortisol may constitute an additional burden for families. Nevertheless, data that were collected suggest that families derive benefit from the AME, which underscores the need for devising innovative methods to understand the neurophysiological impacts of the AME.Item Adding Natural Frequency Data to a Decision Aid for Colorectal Cancer Screening: Results of a Randomized Trial(2013-10-22) Schwartz, Peter H.; Muriello, Paul F.; Perkins, Susan M.; Schmidt, Karen K.; Rawl, Susan M.Guidelines recommend that decision aids provide natural frequency data regarding baseline risk, risk reduction, and chances of false positives and negatives. Such quantitative information may confuse patients, especially those with low numeracy. We conducted a randomized trial to compare effects of 2 colorectal cancer (CRC) screening decision aids—one with and one without natural frequency data.Item Adjuvant Durvalumab Following Trimodality Therapy for Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma(Elsevier, 2021) Mamdani, Hirva; Schneider, Bryan; Perkins, Susan M.; Burney, Heather; Kasi, Pashtoon Murtaza; Abushahin, Laith; Birdas, Thomas; Kesler, Kenneth; Watkins, Tracy M.; Badve, Sunil; Jalal, Shadia I.; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthBackground: Concurrent chemoradiation (CRT) followed by esophagectomy is a standard of care for resectable locally advanced esophageal and gastroesophageal junction (GEJ) adenocarcinoma. The relapse rate is high among patients who do not achieve a pathologic complete response (pCR) following neoadjuvant CRT. Methods: We conducted a phase II study of durvalumab in patients with locally advanced esophageal and GEJ adenocarcinoma who have undergone preoperative CRT followed by R0 resection with histologic evidence of persistent residual disease in the surgical specimen. Patients received durvalumab 1500 mg IV every four weeks for up to one year. The primary endpoint was 1-year relapse free survival (RFS). Findings: Thirty-seven patients were enrolled. The majority (64∙9%) had pathologically positive lymph nodes. One-year RFS was 73%, and median RFS was 21 months (95% CI, 14-40.4 months). Nineteen (51∙4%) patients had PD-L1 CPS of ≥1% and 7 (18∙9%) had PD-L1 CPS of ≥10%. There was a numerical trend toward superior 1-year RFS among patients with PD-L1 positive disease compared to those with PD-L1 negative disease, using CPS of ≥10% (100% vs 66.7%, p=0.1551) and ≥1% (84.2% vs 61.1%, p=0.1510) cutoffs. The most common treatment related adverse events were fatigue (27%), diarrhea (18.9%), arthralgia (16.2%), nausea (16.2%), pruritus (16.2%), cough (10.8%), and increase in AST/ALT/bilirubin (10.8%). Three (8.1%) patients developed grade 3 immune mediated adverse events, including pneumonitis(1), colitis(1), and hepatitis(1). Interpretation: Adjuvant durvalumab in patients with residual disease in the surgical specimen following trimodality therapy for locally advanced esophageal and GEJ adenocarcinoma led to clinically meaningful improvement in 1-year RFS compared to historical control rate. Higher PD-L1 expression may have a correlation with the efficacy of durvalumab in this setting.Item Adverse childhood experiences, insecure attachment, and appointment compliance in an outpatient addiction psychiatry treatment population(Wiley, 2025) Chambers, Joanna E.; Perkins, Susan M.; Mosesso, Kelly M.; Ahdoot, Azziza; Arnaudo, Camila L.; Chambers, R. Andrew; Psychiatry, School of MedicineBackground and objectives: Suffering adverse childhood experiences (ACEs) increases the probability of developing adult mental illness, addictions, and insecure attachment. This study determined how ACEs and insecure attachment are associated with each other, and how they may predict treatment engagement in an integrated dual diagnosis treatment clinic. Methods: A sample of n = 264 patients entering a university-affiliated addiction psychiatry clinic underwent diagnostic intakes supplemented by assessments of attachment styles (Anxious/Avoidant, using the 36-item Experiences in Close Relationships-Relationship Structures (ECR-RS) scale) and childhood adversity (10-item Adverse Childhood Experiences Questionnaire (ACE-Q) scale). Compliance with psychotherapy versus medication appointments was tracked for 6 months post intake. Results: ACE-Q scores (median of 4) were significantly associated with higher anxious and avoidant attachment scores and the number of mental health diagnoses. Only one in five patients obtained 75% or higher compliance rates with psychotherapy; two in five achieved 75% or higher compliance with medication appointments. Greater anxious attachment predicted lower show rates for both psychotherapy and medication appointments, whereas greater avoidant attachment predicted lower compliance for psychotherapy only. Discussion and conclusions: This study confirms the linkage of ACEs and insecure attachment patterns in dual-diagnosis patients seeking integrated addiction psychiatry care. Insecure attachment patterns differentially predicted lower appointment compliance, particularly for psychotherapies. Scientific significance: Childhood trauma and associated adult attachment dysfunction warrant further investigation not only as causes and correlates of mental illness and addiction but also for improving treatment engagement, therapeutic attachments, and recovery outcomes.Item Assessing Negative Attributions After Brain Injury With the Ambiguous Intentions Hostility Questionnaire(Wolters Kluwer, 2020-09) Neumann, Dawn; Sander, Angelle M.; Perkins, Susan M.; Bhamidipalli, Surya Sruthi; Witwer, Noelle; Combs, Dennis; Hammond, Flora M.; Physical Medicine and Rehabilitation, School of MedicineOBJECTIVES: (1) To explore the construct validity of the Ambiguous Intentions Hostility Questionnaire (AIHQ) in participants with traumatic brain injury (TBI) (ie, confirm negative attributions are associated with anger and aggression); and (2) use the AIHQ to examine negative attribution differences between participants with and without TBI. SETTING: Two rehabilitation hospitals. PARTICIPANTS: Eighty-five adults with TBI and 86 healthy controls (HCs). DESIGN: Cross-sectional survey. MAIN MEASURES: The AIHQ, a measure of negative attributions (intent, hostility, and blame), anger, and aggressive responses to hypothetical scenarios. RESULTS: Attributions were significantly correlated with anticipated anger and aggressive responses to AIHQ scenarios. Compared with HCs, participants with TBI reported stronger negative attributions (P ≤ .001), anger (P = .021), and aggressive responses (P = .002) to the scenarios. CONCLUSION: Negative attributions were associated with anger and aggression responses, demonstrating construct validity of the AIHQ in the TBI population. Participants with TBI judged others' behaviors more severely than HCs, similar to prior research using a different attribution measure. The AIHQ has promise as a practical instrument for assessing negative attributions after TBI.