Treatment Trials

75 Clinical Trials for Various Conditions

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WITHDRAWN
Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers
Description

We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers. PRIMARY OBJECTIVES: 1. To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers. SECONDARY OBJECTIVES: 1. Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories 2. Collect details about the tumor specimen extracted from patient charts.

RECRUITING
GYNecologic Cancer-Related COGnitive Impairment
Description

The goal of this study is to test a home-based and patient-tailored cognitive training intervention among gynecologic cancer patients who have completed chemotherapy and who have experienced cancer-related cognitive impairment.

RECRUITING
ASk Questions in GYnecologic Oncology (ASQ-GYO)
Description

The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.

ACTIVE_NOT_RECRUITING
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Description

This clinical trial studies how well an electronic (e)-health intervention (day-by-day) woks in managing fears or worries about cancer growing, spreading, or getting worse (progression) in patients with stage III or IV gynecologic cancer. Fear and worries about cancer progression or recurrence (coming back) are common concerns. This may contribute to concerns related to illness, worries, and uncertainty about the future. Day by Day is adapted from a program called "Conquer Fear" which was shown to benefit patients with early-stage cancer. Day-by-day intervention may help refocus patient thoughts and help patients learn skills to manage anxiety and fears.

ACTIVE_NOT_RECRUITING
Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
Description

The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.

RECRUITING
PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
Description

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

RECRUITING
Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)
Description

The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.

RECRUITING
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers
Description

Human papilloma virus-related gynecologic malignancies affect over 20,000 women in the United States, and over half a million women globally each year. In addition, approximately 200,000 women are diagnosed with high-grade cervical dysplasia, a pre-cancerous tumor. There is no currently available serum biomarker for these tumors, and surveillance and diagnosis in these patients often requires invasive testing and procedures. The ability to diagnose and monitor for these cancers with a simple blood draw would have a significant impact both here in the US and abroad. In order to detect circulating tumor-specific HPV DNA, the investigators will collaborate with the molecular diagnostics company, Naveris. Naveris has designed a blood test that utilizes digital droplet polymerase chain reactions (PCR) in order to quantify fragments of tumor-specific DNA that the investigators believe is shed by HPV-associated cancer cells in the blood. In this pilot study, the investigators will first test whether the quantification of plasma cell-free HPV DNA can distinguish pre-invasive from invasive cervical cancers.

RECRUITING
Mindfulness in Endometrial and Cervical Cancer
Description

Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated treatment.

COMPLETED
Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer
Description

This phase I trial studies a sexual health counseling intervention during radiation therapy in improving quality of life for women with gynecologic cancer. Women with gynecologic cancer often suffer long-term complications from treatment that can affect their physical and psychological well-being. An early sexual health counseling intervention prior to and after radiation may improve symptoms management and reduce the physical and psychological effects of treatment.

Conditions
Malignant Female Reproductive System NeoplasmStage I Cervical Cancer AJCC v8Stage I Uterine Corpus Cancer AJCC v8Stage I Vaginal Cancer AJCC v8Stage I Vulvar Cancer AJCC v8Stage IA Cervical Cancer AJCC v8Stage IA Uterine Corpus Cancer AJCC v8Stage IA Vaginal Cancer AJCC v8Stage IA Vulvar Cancer AJCC v8Stage IA1 Cervical Cancer AJCC v8Stage IA2 Cervical Cancer AJCC v8Stage IB Cervical Cancer AJCC v8Stage IB Uterine Corpus Cancer AJCC v8Stage IB Vaginal Cancer AJCC v8Stage IB Vulvar Cancer AJCC v8Stage IB1 Cervical Cancer AJCC v8Stage IB2 Cervical Cancer AJCC v8Stage II Cervical Cancer AJCC v8Stage II Uterine Corpus Cancer AJCC v8Stage II Vaginal Cancer AJCC v8Stage II Vulvar Cancer AJCC v8Stage IIA Cervical Cancer AJCC v8Stage IIA Vaginal Cancer AJCC v8Stage IIA1 Cervical Cancer AJCC v8Stage IIA2 Cervical Cancer AJCC v8Stage IIB Cervical Cancer AJCC v8Stage IIB Vaginal Cancer AJCC v8Stage III Cervical Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage III Vaginal Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA Vulvar Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIB Vulvar Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC Vulvar Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVA Vaginal Cancer AJCC v8Stage IVA Vulvar Cancer AJCC v8
ACTIVE_NOT_RECRUITING
Self-Hypnosis for the Enhanced Recovery After Surgery in Patients with Gynecologic Cancer
Description

This trial studies how well self-hypnosis works in enhancing recovery after surgery in patients with gynecologic cancer. A guided relaxation method called self-hypnosis may help affect how patients feel pain and symptoms after surgery.

ACTIVE_NOT_RECRUITING
A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer
Description

This research is studying the level of oxygen in tumors during the brachytherapy procedure.

RECRUITING
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
Description

This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.

COMPLETED
Nivolumab with or Without Ipilimumab in Treating Patients with Recurrent or High Grade Gynecologic Cancer with Metastatic Peritoneal Carcinomatosis
Description

This phase Ib trial studies the side effects and best dose of nivolumab with or without ipilimumab in treating patients with female reproductive cancer that has come back (recurrent) or is high grade and has spread extensively throughout the peritoneal cavity (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

TERMINATED
Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer
Description

This research study is evaluating the safety and effectiveness of 2 immunotherapy drugs in combination with radiation therapy as a possible treatment for recurrent or metastatic gynecologic cancer. The names of the immunotherapy drugs involved in this study are: * Durvalumab * Tremelimumab

COMPLETED
CPR Decision Aid For Patients With Advanced Gynecologic Malignancies
Description

The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.

COMPLETED
Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
Description

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.

COMPLETED
Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy
Description

To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.

COMPLETED
Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
Description

This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.

COMPLETED
Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients
Description

The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.

TERMINATED
Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers
Description

This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.

COMPLETED
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
Description

This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

COMPLETED
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
Description

This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.

COMPLETED
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
Description

This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.

COMPLETED
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Description

Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.

COMPLETED
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
Description

There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment. The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.

COMPLETED
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Description

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).

COMPLETED
Pelvic Floor Disorders in Survivors of Gynecologic Malignancies
Description

Pelvic Floor dysfunction affects the quality of life of women. However, the prevalence and risk factors for pelvic floor disorders (PFD) in survivors of gynecologic malignancies are not known. The investigators plan to perform an observational study including survivors of gynecologic malignancies. Questionnaires for diagnosis of pelvic floor disorders will be mailed to survivors to generate prevalence rates and risk factors for PFD in women with a history of a gynecologic cancer diagnosis.

COMPLETED
Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery
Description

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.

UNKNOWN
Pelvic Fractures and Radiation Therapy for Cervical Cancer
Description

The goal of this study is to estimate how often pelvic fractures occur in women treated with radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal cancer. The study will also estimate the changes in bone mineral density and the changes in the blood that relate to "bone turnover". High bone turnover can weaken bones and make you more likely to break a bone.