Couple-Focused Intervention for Colorectal Cancer Screening
Specific Aim 1:To compare the efficacy of three interventions: Enhanced Couple-Tailored Intervention (E-CTI), an Enhanced Couples' Generic Intervention (E-GCI), and a Generic Print Intervention (GP) on couples' CRCS.
Hypothesis:CRCS rates at follow-up will be 22-30% in E-CTI, 12-15% in E-GCI, and 8% in GP.
Specific Aim 2:To evaluate the individual (perceived risk, decisional balance, planning, intentions) and relationship-level (relationship perspective, support for spouse screening, couples'discussions) factors which mediate E-CTI effects on couples' CRCS when compared with E-GCI and GP.
Hypothesis: E-CTI will result in significantly higher risk, more positive decisional balance, greater planning, higher CRCS intentions, adoption of greater relationship perspective on CRCS, more support for the partner's CRCS, and more frequent CRCS discussions when compared with E-GCI and GP, and that the meditational effect will be stronger in E-CTI.
Exploratory Aim: To evaluate the individual (gender, baseline intentions, support for spouse's screening, insurance status) and relationship-level (marital quality) factors which moderate E-CTI effects on couples' CRCS practices when compared with E-GCI and GP.
Improving Patient Access to Quality Cancer Treatment (IMPACT)
Specific Aims for Phase I
Develop a survey instrument to collect data on pre- Patient Protection and Affordable Care Act (PPACA) implementation and early phase implementation that may affect access to cancer care, treatment patterns, and outcomes in New Jersey.
a) Examine disparities in access to care and patient experiences among cancer cases by insurance type, comorbidities and various demographic subgroups.
b) Examine the prevalence of concurrent medication use among cancer cases who are undergoing or have undergone cancer-related drug therapies (e.g. chemotherapy, hormone therapy)
Specific Aims for Phase II
1. Use pilot data derived from this project to demonstrate the feasibility and value of collecting population-based patient survey data on New Jersey cancer cases.
2. Expand the survey data collection to New Jersey cancer cases diagnosed and treated in later years to further examine the impact of PPACA implementation (e.g. Medicaid expansion) on access to care.
DEK-DKK1-P102: A Four Part, Phase 1, Multi-center, Open-label Study of DKN-01 in Combination with Weekly Paclitaxel; Part A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Part B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Part C: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal or Gastro-esophageal Junction Adenocarcinoma; Part D: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Squamous Cell Cancer
The primary objective of this study is to characterize the safety and tolerability of DKN-01 in combination with weekly paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer.
The secondary objectives of this study are:
h To estimate the overall response rate (ORR) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To estimate progression free survival (PFS), duration of response (DoR), and overall survival (OS) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To characterize the pharmacokinetics of DKN-01 in combination with paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer
NCI/CTEP #9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinic) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer
Primary Objective: To determine the maximum tolerated dose (MTD)and dose-limiting toxicities (DLT) of the combination of AZD6244 and cyclosporin A in adult patients with advanced solid tumors.
Seconday Objectives: (1) To determine the safety profile and tolerability of thsi regimen in this patient population. (2) To determine the pharmacokinetics of the combination. (3) To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or metastatic CRC. (4) Evaluate the activity of the combination in terms of objective response rate (per RECIST 1.1), overall survival, and progression-free survival.