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ProtocolTrial Name and Objective
130909

Psychological Interventions for Gynecologic Cancer

Very little is known in the psycho-oncology literature about why psychological interventions are effective or for how long these interventions exert an impact. Given many cancer patients experience recurrence and/or progression, it is important to know whether our relatively brief interventions facilitate how patients cope with this most-feared medical event. From a theoretical perspective, the study will advance our understanding of the mechanisms for change for two common treatment approaches, supportive and cognitive behavioral therapies.
Primary Objective: To evaluate the efficacy of CCI, SC, and Usual Care (UC) on patients' long-term general and cancer-specific psychological adaptation, concerns about recurrence/progression, and quality of life, and to determine whether intervention effects are moderated by disease recurrence.
Secondary Objective: To evaluate the cognitive, social, emotional, and behavioral processes which mediate CCI and SC's effects on patients' long-term general and cancer-specific psychological adaptation, concerns about recurrence/progression, and quality of life.
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131222

Dietary Inflammatory Index and Ovarian Cancer Risk

Our study aims to evaluate the role of a new dietary inflammatory index in predicting ovarian cancer risk. We will also compare results with those obtained with the Healthy Eating Index.
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131501

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.
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041501

NSABP B-55: A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Primary Objective The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS)
Safety Objective
To assess the safety and tolerability of adjuvant treatment with olaparib
Secondary Objectives
1.To assess the effect of adjuvant treatment with olaparib on overall survival (OS)

2.To assess the effect of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS)
3.To assess the effect of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer
4.To assess the effect of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale
5.To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future germline BRCA mutation assays (gene sequencing and large rearrangement analysis)
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051304

Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors

To evaluate preliminary signals of potential anti-tumor activity of MK-3475
in subjects with a given a histopathologic type of PD-L1 positive advanced solid tumor based on RECIST 1.1 as determined by the investigator in specific tumor indications
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101401

A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary, Peritoneal, or Fallopian Tube Cancer

OVERVIEW OF STUDY DESIGN
This is a randomized, open-label, active-controlled, multicenter study designed to assess the efficacy and safety of trabectedin (Yondelis©) + DOXIL as a third-line chemotherapy in subjects with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy. Approximately 670 subjects will be enrolled in this study, with 335 subjects per planned treatment group. Patients will be paid $42 to help cover their expenses for attending the study visits. These expenses include travel expenses and meals.
Primary Objective
* To compare the overall survival (OS) after treatment with trabectedin (Yondelis©)+DOXIL combination therapy to that observed after treatment with DOXIL monotherapy, for subjects with platinum-sensitive, advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer, who have received 2 previous lines of platinum-based chemotherapy.

Secondary Objectives
* To evaluate progression free survival (PFS).
* To evaluate the objective response rate (ORR).
* To characterize the plasma pharmacokinetics of trabectedin(Yondelis©)using
a sparse sampling scheme in the trabectedin(Yondelis©)+DOXIL treatment group.
* To evaluate the safety of the trabectedin(Yondelis©)+DOXIL combination therapy and Doxil monotherapy.

Exploratory Objectives
* To conduct pharmacogenomic evaluations of overall survival (OS), progression free survival (PFS) and other endpoints in subjects with and without mutations in their
BRCA1 or BRCA2 genes.
* To evaluate patient-reported outcomes (PROs).
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101302

GOG-0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube And Primary Peritoneal Cancer Progression-Free Survival?

Primary Objective
1.11 To determine if women who are disease-free after successfully completing
primary and potential consolidation/maintenance, therapy for Stage II-IV
ovarian, fallopian tube or primary peritoneal cancer and who are randomized to
a healthy lifestyle intervention, will have significantly increased progression free survival compared to similar women who are randomized to a usual care comparison group.
1.2 Secondary Objectives
1.21 To determine if women who are randomized to the study intervention will have:
1.211 Improved general quality of life as measured by the General Health
subscale of RAND-36.
1.212 Improved physical and bowel functioning as measured by the Physical
Functioning subscale of RAND-36 and the GSRS-IBS, compared to
women who are randomized to usual care.
1.3 Exploratory Objectives:
1.31 To perform a pilot assessment at baseline, 6, 12, and 24 month dietary
biomarkers in a sub-sample of the study population to estimate compliance with
the healthy lifestyle intervention and to explore the relationship between
carotenoid exposure and progression free survival from ovarian cancer.
1.32 To examine patient compliance with the healthy lifestyle intervention and to assess which types of patients are more likely to be compliant with the healthy lifestyle intervention and whether progression-free survival is better among compliant individuals.
1.33 To explore the impact of the intervention on other aspects of quality of life such as: pain, role limitations due to physical health and emotional problems, mental health, vitality, and social functioning as measured by the corresponding subscales of the RAND-36.
1.34 To explore the impact of the intervention on bowel functioning as measured
with the GSRS-IBS subscales.
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