Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study
Breast NeoplasmsOvarian Neoplasms2 moreStudies show that cancer survivors have unmet needs, the most frequently cited being fear of recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of cancer patients and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased health care utilization. Little evidence exists that these problems are being addressed by current medical management.
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer...
Anxiety DisorderDepression18 moreThis 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.
Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors...
Endometrial CancerObesityThis pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With...
Anxiety DisorderCervical Cancer9 moreThis 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.
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health...
Ovarian CancerEndometrium CancerEarlier diagnoses and improved treatments have contributed to the growing cohort of cancer survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical or psychosocial effects of cancer and its treatment. There is increasing recognition to improve information disclosure and cancer survivorship care. The American Institute of Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors receive a summary of their course of treatment as a formal document, that also includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence exists concerning the positive and negative effects of the implementation of the SCP in daily clinical practice. The purpose of this study is to assess the impact of SCP care in routine clinical practice on cancer survivors' satisfaction with information disclosure and care, quality of life, illness perception, and health care use.
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin...
Breast CancerDrug/Agent Toxicity by Tissue/Organ4 moreRATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome. PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving liposomal doxorubicin for recurrent ovarian, fallopian tube, or peritoneal cancer, metastatic breast cancer, or advanced endometrial cancer.
Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal...
Cervical CancerEndometrial Cancer3 moreRATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer. PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.
Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
Gynecologic CancerOvarian Cancer3 moreThe primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Patient reported anxiety will be evaluated using a validated Patient-Reported Outcomes Measurement Information System (PROMIS) survey. We hypothesize that the group counseling session will reduce patient reported anxiety by a clinical meaningful level. Secondary objectives will evaluate the effect of the intervention on patient reported depression levels and compare adherence to Enhanced Recovery After Surgery (ERAS) instructions, utilization of unscheduled health care resources, and anxiety/depression levels to historical controls.
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing...
Cervical CancerEndometrial Cancer2 moreThis 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.
POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus
CarcinomaEndometrioid1 moreType of Application: Clinical trial of new indication. Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09. Primary Objective: To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus. This is an exploratory clinical study. No efficacy objectives are included in this clinical trial. Secondary Objectives: To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus. To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR), To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status. To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure To collect data about the differences in expression profile, assessed by RNA microarrays