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ProtocolTrial Name and Objective

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.


Retrospective Comparative Analysis of Hematologic Toxicities in Patients Receiving Chemo-Radiotherapy in Rectal Cancers Versus Chemotherapy in Colon Cancers.

To quantify bone marrow toxicity after radiation therapy in rectal cancer patients compared to bone marrow toxicity without radiation therapy in colon cancer patients.


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.


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.