Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Anxiety Disorders

Carcinoma

Breast Neoplasms

Recurrence

Depression

Depressive Disorder

Fatigue

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Pain

Sarcoma

Trophoblastic Neoplasms

Pseudomyxoma Peritonei

Leydig Cell Tumor

Fallopian Tube Neoplasms

Endometrial Neoplasms

Peritoneal Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Mental Disorders

Psychotic Disorders

Neoplasms, Germ Cell and Embryonal

Fallopian Tube Diseases

Adnexal Diseases

Neoplasms, Glandular and Epithelial

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Vulvar Diseases

Vaginal Diseases

Pregnancy Complications, Neoplastic

Adenocarcinoma

Adenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Sertoli-Leydig Cell Tumor

Sex Cord-Gonadal Stromal Tumors

Testicular Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Fallopian Tube Cancer

Vulvar Cancer

Ovarian Germ Cell Tumor

Gestational Trophoblastic Tumor

Uterine Sarcoma

Sertoli-leydig Cell Tumors

Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising MBSR, an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.

questionnaire administration

Patients will participate in a quality life assessment.

quality-of-life assessment

Participate in multi-component biobehavioral intervention

psychosocial assessment and care

behavioral intervention

A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer.

cognitive intervention

educational intervention

Barbara Andersen, PhD

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.

PRIMARY OBJECTIVES:

I. To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.

III. To provide a preliminary test of its efficacy.

OUTLINE:

Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.

After completion of study treatment, patients are followed up at 28 weeks.

Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Quality of life as assessed by Short Form (SF)-36

Study participants will also collect saliva samples at home 4 times a day for 3 days. Saliva samples will be collected at the baseline, mid-treatment, post-treatment and 3-month follow-up assessments. These samples will be used to measure cortisol.

Blood samples will be used to measure levels of inflammatory markers. Blood draws will be coordinated with the participants' regularly scheduled blood draws to minimize discomfort.

National Cancer Institute (NCI)

Ohio State University Comprehensive Cancer Center

Principal Investigator

Testicular Germ Cell Tumor

RNA analysis

gene expression analysis

mutation analysis

reverse transcriptase-polymerase chain reaction

laboratory biomarker analysis

medical chart review

Dana A. Hill, MD

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.

OBJECTIVES:

* To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.

OUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.

Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors

DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood

Children's Oncology Group

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Antimetabolites

Patients also receive carboplatin IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.

stereotactic body radiation therapy

carboplatin

gemcitabine hydrochloride

pharmacogenomic studies

Steven Waggoner, MD

The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.

PRIMARY OBJECTIVES:

I. Determine maximum tolerated carboplatin/gemcitabine dose administered with SBRT as measured by \< 30-day acute toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

SECONDARY OBJECTIVES:

I. Off-study SBRT target local control assessment: 6-week post-trial fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) or other imaging response by European Organisation for Research and Treatment of Cancer (EORTC) PET criteria as listed and National Cancer Institute (NCI) guidelines.

II. Off-treatment late toxicity assessment: record 3-month and 6-month radiation-related toxicity defined by CTCAE v4.0.

III. Off-study global clinical benefit assessment: 6-month post-therapy clinical benefit (defined as percentage of patients who had complete, partial, or stable disease for at least 6 months).

TERTIARY OBJECTIVES:

I. Associate pretherapy tumor biopsy ribonucleotide reductase (R1, R2, p53R2), Tip60 and Poly(ADP-ribose) polymerase 1/2 expression with 6-week therapy response.

OUTLINE: This is a dose-escalation study of carboplatin and gemcitabine hydrochloride.

Patients also receive carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.

Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer

A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer

A modified Fibonacci design used during the dose-finding portion of this study. When =\< 1 out of 6 patients enter at highest next dose level below the maximum tolerated dose (MTD), this is the recommended phase 2 dose. At least 6 patients must be entered at the recommended phase 2 dose.

Calculated following the method of Kaplan and Meier and survival dependence on measured covariates will be assessed using the Cox proportional hazards model.

Descriptive and tabular data will be reported. Assessed using the Cox proportional hazards model.

Case Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer	NCT01764789	Anxiety Disorde... Depression Fatigue Leydig Cell Tum... Ovarian Sarcoma Ovarian Stromal... Pain Peritoneal Carc... Pseudomyxoma Pe... Recurrent Breas... Recurrent Cervi... Recurrent Endom... Recurrent Fallo... Recurrent Gesta... Recurrent Ovari... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Vagin... Recurrent Vulva...	questionnaire a... quality-of-life... psychosocial as... behavioral inte... cognitive inter... educational int...	21 Years - 85 Years	Ohio State University Comprehensive Cancer Center
Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors	NCT01572467	Childhood Germ ... Leydig Cell Tum... Ovarian Cancer	RNA analysis gene expression... mutation analys... reverse transcr... laboratory biom... medical chart r...	- 120 Years	Children's Oncology Group
Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors	NCT01572467	Childhood Germ ... Leydig Cell Tum... Ovarian Cancer	RNA analysis gene expression... mutation analys... reverse transcr... laboratory biom... medical chart r...	- 120 Years	Children's Oncology Group
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer	NCT01764789	Anxiety Disorde... Depression Fatigue Leydig Cell Tum... Ovarian Sarcoma Ovarian Stromal... Pain Peritoneal Carc... Pseudomyxoma Pe... Recurrent Breas... Recurrent Cervi... Recurrent Endom... Recurrent Fallo... Recurrent Gesta... Recurrent Ovari... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Vagin... Recurrent Vulva...	questionnaire a... quality-of-life... psychosocial as... behavioral inte... cognitive inter... educational int...	21 Years - 85 Years	Ohio State University Comprehensive Cancer Center
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer	NCT01652794	Leydig Cell Tum... Ovarian Sarcoma Ovarian Stromal... Pseudomyxoma Pe... Recurrent Cervi... Recurrent Endom... Recurrent Fallo... Recurrent Ovari... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Vagin... Recurrent Vulva...	stereotactic bo... carboplatin gemcitabine hyd... laboratory biom... pharmacogenomic...	19 Years -	Case Comprehensive Cancer Center

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