Participants randomized to the lite group will receive a Medication Event Monitoring System (MEMS) device with feedback. Participants will be advised to only open their pill bottles when they take their medications. Participants will also be given a MEMS diary to record unscheduled cap openings, such as those to refill the bottle, so that those unscheduled events unrelated to adherence can be removed from analysis. The nurse coach will explain to the participant how to interpret the feedback report.

Before beginning their OCA regimen, participants in Arm 2 will be administered a barriers/facilitators screening tool that will help the nurse coach identify specific adherence strategies (i.e. cognitive education, knowledge skills, and affective support) tailored to the participant's needs. Once a tailored intervention plan is developed, participants will receive a 60-minute session conducted by the nurse coach. Participants will receive weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period (whichever occurs first).

Medication Adherence

Participants randomized to the intervention 2 group will receive the MEMS, plus a tailored nurse coach component. Participants will receive a 60-minute session conducted by the nurse coach. Participants will receive weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period (whichever occurs first). MEMS feedback will be used to show Participants their own medication-taking behavior via the MEMS Report, to correct any misperceptions of actual adherence and to identify problem areas. The nurse coach will modify the intervention plan to address identified barriers to adherence at this time.

Nurse Coach Intervention

Participants will be advised to only open their pill bottles when they take their medications. Participants will also be given a MEMS diary to record unscheduled cap openings, such as those to refill the bottle, so that those unscheduled events unrelated to adherence can be removed from analysis. Participants will meet with the nurse coach during their regularly scheduled monthly oncology visits where the MEMS data will be collected. During this monthly meeting, participants in the intervention 1 group will receive feedback of their medication-taking behavior via a MEMS report.

MEMs Intervention

Vidant Medical Center

Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence

A Randomized Longitudinal Intervention Study to Assess the Efficacy and Feasibility of Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence and Health Literacy Among Cancer Patients.

Within the 6-month follow-up period, was the participant adherent to their prescribed oral chemotherapeutic regimen.

Did the participant increase their health literacy via the nurse coach intervention provided

Looking at ER visits, hospitalizations and length of stay during the course of the study.

Essie Torres

Assistant Professor

East Carolina University

Celiac Block with triamcinolone and bupivicaine Intra Plexus Triamcinolone and Bupivicaine Injection

Patients will undergo EUS but no celiac block will be performed

Pancreatitis, Chronic

Pancreatitis

Endosonography of the pancreas performed following by analgesic injection

Celiac Block with triamcinolone and bupivicaine

No Celiac Block

Injection of Triamcinolone and Bupivicaine into celiac plexus for pain relief

Intra Plexus Triamcinolone and Bupivicaine Injection

Los Angeles County Hospital

Celiac Plexus Block for Chronic Pancreatitis RCT

Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis

Primary outcomes will be the CHANGE pain score (as assessed by the visual-analogue-scale and M-ANNHEIM score assessed between time 0 and 24 weeks post procedure in those who undergo EUS without block (control) compared to those who undergo EUS with block

differences in number of hospital re-admissions for pancreatic pain assessed at 24 weeks between those who underwent the block and did not undergo the celiac block

CHANGE in pain medication requirement 24 weeks following celiac block in those who underwent EUS guided celiac block compared to those who did not

Post procedure complications include infection (defined as fever or increased WBC without an alternative cause), diarrhea (defined as 3 loose stools per day), or pancreatitis (defined as increased pain and lipase >3 X the upper limit of normal). Will be assessed 2 weeks after the procedure and compared between those who EUS with block compared to EUS without block

James Buxbaum

University of Southern California

Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours

Docetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.

Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days

DOCOX

Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days

DOCOX+Cebuximab

Total

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Progression-free Survival

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

Overall Survival

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Objective Response Rate (ORR)

For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

Time to Response

The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

Duration of Response

Overall Study

Dr. Donald Richards

Gastric Cancer Adenocarcinoma Metastatic

Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour

Docetaxel

ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.

cetuximab

oxaliplatin

Birmingham Hematology and Oncology

Hematology Oncology Associates

Rocky Mountain Cancer Center - Midtown

Florida Cancer Institute

Ocala Oncology Center

Hematology Oncology Associates of Illinois

Cancer Care & Hematology Specialists of Chicagoland

Central Indiana Cancer Centers

Hope Center

Kansas City Cancer Centers - Southwest

Minnesota Oncology Hematology, P.A.

Missouri Cancer Associates

New York Oncology Hematology, P.C.

Interlakes Oncology Hematology, PC

Cancer Centers of North Carolina

Mahoning Valley Hematology Oncology Associates

Greater Dayton Cancer Center

Medical Oncology Associates

Texas Oncology, P.A. Amarillo

Texas Cancer Center

Texas Oncology Cancer Center

Mamie McFaddin Ward Cancer Center

Texas Oncology, P.A. - Bedford

Texas Cancer Center at Medical City

Texas Oncology, P.A.

Methodist Charlton Cancer Ctr.

El Paso Cancer Treatment Ctr

Lake Vista Cancer Center

Longview Cancer Center

Texas Cancer Center of Mesquite

Allison Cancer Center

Texas Oncology - Odessa

Paris Regional Cancer Center

Tyler Cancer Center

Texas Oncology Cancer and Research

Fairfax Northern VA Hem-Onc PC

Virginia Oncology Associates

Onc and Hem Associates of SW VA, Inc.

Puget Sound Cancer Center - Edmonds

Columbia Basin Hematology & Oncology

Puget Sound Cancer Center - Seattle

Cancer Care Northwest - South

Northwest Cancer Specialist - Vancouver

Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma

oxalis tuberosa/neoplasms

Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence

Celiac Plexus Block for Chronic Pancreatitis RCT

Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

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