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Breast Cancer clinical trials

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NCT ID: NCT02600299 Completed - Breast Cancer Clinical Trials

Effectiveness of a Psycho-educational Group (PEG) Intervention on Supportive Care and Survivorship Issues in Early-stage Breast Cancer Survivors Who Have Received Systemic Treatment

Start date: July 2015
Phase: Phase 2
Study type: Interventional

As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported outcomes and survivorship issues. In view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. In the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related QOL. The investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. Hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (PEG) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.

NCT ID: NCT02599506 Completed - Breast Cancer Clinical Trials

Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment

FORECAST
Start date: December 1, 2015
Phase:
Study type: Observational

This pilot study concentrates on studying the trajectory of breast cancer patient's fear of recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.

NCT ID: NCT02597452 Completed - Breast Cancer Clinical Trials

Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

iBE
Start date: March 2014
Phase: N/A
Study type: Interventional

The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.

NCT ID: NCT02594696 Completed - Breast Cancer Clinical Trials

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

Start date: November 9, 2015
Phase: N/A
Study type: Interventional

Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are dying younger than the general population; cancer is a leading cause of death in this population. People with SMI have higher rates of dying from breast, lung, and colon cancer, and disparities in treatment appear to be one contributing factor. Individuals with SMI may be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate cancer treatment. Although collaborative care models integrating medical and psychiatric care have shown promise in other populations, the challenge of treating SMI and cancer is distinct and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can impact their understanding of their diagnosis and treatment decisions. Oncologists have less training and inadequate time to address multiple unmet needs. Mental health care is frequently fragmented from cancer care. The investigators want to understand if it is helpful for patients with SMI to be connected to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms and facilitating communication between the patient, the oncology team, and mental health providers may improve care. The goal is to pilot a pragmatic intervention for patients with cancer and SMI that can be integrated into cancer care, is acceptable to patients and oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an underserved population. Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will follow the patient and communicate with the oncology team during the 12 week intervention. All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment received and healthcare utilization will be assessed at 6 months post-intervention.

NCT ID: NCT02593227 Completed - Breast Cancer Clinical Trials

Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer

Start date: April 2016
Phase: Phase 2
Study type: Interventional

This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).

NCT ID: NCT02592070 Completed - Breast Cancer Clinical Trials

Activity & Cognition After Treatment for Breast Cancer

ACT
Start date: July 2015
Phase: N/A
Study type: Interventional

This study addresses an important public health concern; impoverished cognitive function associated with treatment of breast cancer. Due to increased awareness of breast cancer combined with advances in medical care, there are over 2.8 million women living with a history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function. However, most of the literature is cross-sectional and it is unclear whether acute (single) bouts of physical activity affect cognition and, if they do, how long this effect lasts. This study will be the first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic exercise on cognitive functioning in breast cancer survivors. Specifically, the investigators will determine the effects of a 30-minute moderate intensity aerobic exercise session (treadmill walking) on immediate and one hour follow up changes in measures of processing speed, memory, and executive function. Additionally, accelerometer cut-points for physical activity intensities in breast cancer survivors will be assessed. Finally, the investigators will examine the association of cardiorespiratory fitness and physical activity with changes in cognitive function. Findings from this study will allow researchers to determine whether any acute effects of exercise on cognition are retained over time and therefore have real meaning in the context of one's daily life.

NCT ID: NCT02591316 Completed - Breast Cancer Clinical Trials

Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors

Start date: February 2015
Phase: N/A
Study type: Observational

The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.

NCT ID: NCT02590458 Completed - Breast Cancer Clinical Trials

Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer

Start date: October 26, 2015
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).

NCT ID: NCT02586987 Completed - Breast Cancer Clinical Trials

A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours

Start date: December 28, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, multi-centre, drug combination study of double and triple combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours.

NCT ID: NCT02586675 Completed - Breast Cancer Clinical Trials

TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer

Start date: February 23, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast cancer.