Testing the effects of a prenatal depression preventive intervention on parenting and young children's self-regulation and functioning (EPIC): protocol for a longitudinal observational study.

BACKGROUND: Perinatal depression is a pervasive public health concern that disproportionately affects low-income women and can have negative impacts on parenting and child developmental outcomes. Few interventions focus on preventing perinatal depression. Previous studies suggest that Mothers and Babies is efficacious in preventing the worsening of depressive symptoms and the onset of postpartum depression. This manuscript presents the protocol of the EPIC study (Effects of a Prenatal Depression Preventive Intervention on parenting and young children's Self-Regulation and Functioning) to test the effects of Mothers and Babies on parenting and child developmental outcomes through 54 months postpartum. EPIC is an observational study that builds on a completed cluster-randomized trial (CRT). Innovations of this study are direct observations of a subsample of mother-child dyads and the inclusion of fathers/caregivers' variables as moderators of maternal mental health. METHODS: For this study, we plan to enroll 738 women with children under 30 months old, ≥18 years old, and who speak English or Spanish. Additionally, 429 fathers, partners, or other adult caregivers will be recruited through women participating in the study. Women will be recruited through the parent study (intervention and control participants) or through one of 10 home visiting programs in Illinois (control participants). Data collection will take place through maternal self-report at five time points (when the child is 30, 36, 42, 48, and 54 months), paternal self-report at three time points (when the child is 30, 42, and 54 months), and through mother-child observations at three time points (when the child is 36, 42, and 48 months). Outcome domains include maternal mental health, cognitive-behavioral and parenting skills, and child self-regulation and functioning. Moderators include the contributions of fathers/caregivers, race-ethnicity, and socioeconomic disadvantage. Power and sample size were calculated assuming a two-sided 5% type I error rate and assumed analyses on the individual level. DISCUSSION: This study has several key strengths and innovations, as well as great potential significance to influence the long-term trajectories of parenting and child development via prenatal intervention. TRIAL REGISTRATION: The study was retrospectively registered at ClinicalTrials.gov (Identifier: NCT04296734 ) on March 5, 2020.

Lessons From Medicaid's Divergent Paths On Mental Health And Addiction Services.

Over the past fifty years Medicaid has taken divergent paths in financing mental health and addiction treatment. In mental health, Medicaid became the dominant source of funding and had a profound impact on the organization and delivery of services. But it played a much more modest role in addiction treatment. This is poised to change, as the Affordable Care Act is expected to dramatically expand Medicaid's role in financing addiction services. In this article we consider the different paths these two treatment systems have taken since 1965 and identify strategic lessons that the addiction treatment system might take from mental health's experience under Medicaid. These lessons include leveraging optional coverage categories to tailor Medicaid to the unique needs of the addiction treatment system, providing incentives to addiction treatment programs to create and deliver high-quality alternatives to inpatient treatment, and using targeted Medicaid licensure standards to increase the quality of addiction services.

A retrospective study of capecitabine/temozolomide (CAPTEM) regimen in the treatment of metastatic pancreatic neuroendocrine tumors (pNETs) after failing previous therapy.

CONTEXT: Pancreatic neuroendocrine tumors (pNETs) are notoriously resistant to currently available chemotherapy agents. Preclinical data has suggested synergy between temozolomide and capecitabine. OBJECTIVE: To report a retrospective data on the efficacy and safety of capecitabine and temozolomide (CAPTEM regimen) in patients with metastatic pancreatic neuroendocrine tumors (pNETs) who have failed prior therapies. METHODS: We reviewed the medical records of 7 patients with metastatic pNETs who had had progressive cancer prior to treatment despite therapy, including long-acting release octreotide (60 mg/month), chemotherapy and hepatic chemoembolization. Capecitabine was administered at a flat dose of 1,000 mg orally twice daily on days 1-14 and temozolomide 200 mg/m² was given in two divided doses daily on days 10-14 of a 28-day cycle. Tumor assessments were repeated every two cycles and serum tumor markers were measured every cycle. Response to treatment was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) parameters, and toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. RESULTS: Among 7 patients treated, three patients achieved a partial response, and two patients had stable disease. Total response rate was 43%, and clinical benefit (responders and stable disease) was 71%. Median duration of response was 8 months (range: 4-12 months). Grade 3 and 4 toxicities included grade 3 thrombocytopenia in one patient and grade 3 fatigue in one patient. The most common toxicities were grade 1 and 2 neutropenia, grade 1 fatigue, grade 1 and 2 hand-foot syndrome. CONCLUSIONS: Our retrospective study showed that modified CAPTEM regimen was well-tolerated and produced comparable response to historical data in neuroendocrine tumors, including pNETs. Our study is unique as it only included patients with pNETs. Further prospective studies are warranted to evaluate the combination of CAPTEM regimen with targeted therapies in pNETs.

Mitomycin-C and capecitabine (MIXE) as salvage treatment in patients with refractory metastatic colorectal cancer: a retrospective study.

AIM: To report on the efficacy and safety of mitomycin-C-capecitabine (MIXE) regimen as salvage chemotherapy regimen for patients with refractory metastatic colorectal cancer. PATIENTS AND METHODS: We retrospectively reviewed patients who were treated with mitomycin-C (7 mg/m(2)) every three weeks in combination with capecitabine (1,000 mg) twice daily (2,000 mg per day) days 1 to 14 every three weeks. All patients had previously received at least three chemotherapy regimens including biological agents, such as a monoclonal antibody either against vascular endothelial growth factor receptor or epidermal growth factor receptor (only if wild-type KRAS). Laboratory tests including complete blood count were checked weekly, while chemistries, liver function tests and carcinoembryogenic antigen levels were determined every three weeks. Radiological assessment of their disease with computed tomography scans was performed every nine weeks. RESULTS: Fifteen patients were included: Male:female ratio, 9:6; age ranged from 52-70 years; Eastern Cooperative Oncologic Group performance status 1 in 5 patients and 2 in the remaining 10 patients. Seven patients demonstrated a clinical benefit (one partial response, two minor responses, five stable disease), disease in six patients progressed and one patient participated in a phase I clinical study and hence was not evaluable. No grade 3 or 4 hematological toxicities were noticed; the most common toxicities included grade 2 hand-foot syndrome (HFS), grade 1 fatigue and grade 2 diarrhea. CONCLUSION: The MIXE regimen showed a modest efficacy in heavily pre-treated patients with mCRC. The MIXE regimen may be considered for patients with mCRC who are refractory to primary treatment and are without other options or who are not eligible for clinical studies.

Cutaneous metastasis in a patient with pancreatic cancer.

Pancreatic cancer is known to metastasize rapidly. Liver and peritoneum are the most common sites of metastases in pancreatic cancer, followed by lungs, bones and brain. Less common sites of metastases such as muscle, skin, heart, pleura, stomach, umbilicus, kidney, appendix, spermatic cord and prostate have also been reported in pancreatic cancer. Cutaneous metastasis mostly occurs around umbilicus. A site other than umbilicus is rarely reported. The authors report a case of multiple skin metastases in a patient with primary pancreatic cancer and review the literature.

Management of skin toxicities of anti-EGFR agents in patients with pancreatic cancer and other GI tumors by using electronic communication: effective and convenient.

Erlotinib has been FDA approved to be used in combination with gemcitabine as the first line treatment in advanced pancreatic cancer patients. Skin rash has been documented as one of the commonest adverse reactions in patients receiving erlotinib and other EGFR inhibitors. Draw back to this reaction leads to: 1) drug discontinuation or dose reduction; 2) impairs quality of life; and 3) Puts patients at risk of superinfection. Monitoring patients closely and initiating immediate skin care is recommended. However, patients forget how the rash started and when. No standard treatments exist secondary to the diversity of symptoms, variability and intermittent occurrence in relation to the cancer therapy. In addition, there is slow improvement with medical treatment. Also, patients need to make extra visits to doctor's office for skin management when in needed in addition to chemotherapy appointments. Late presentation for medical attention leading to complications, such as sepsis. We here experience a novel way of assessing and managing the skin rash using the electronic media. We suggest that electronic communication is of crucial importance to detect early, diagnose and treat anti-EGFR related skin rash in order to continue the benefit of anti-EGFR.