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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

This clinical trial focuses on women of childbearing age who are scheduled to undergo hysterectomy for non-malignant conditions. It aims to assess whether an innovative approach using a personal narrative book can improve psychological outcomes such as emotional regulation, reduce catastrophizing, anxiety, and depression, compared to the usual care. The study seeks to determine if this method can enhance patient satisfaction and decrease the need for additional psychological support before and after surgery. Participants will be randomly assigned to one of two groups one receiving standard care, which includes an informational leaflet and psychological consultation if needed, and the other receiving the same standard care plus a personal narrative book written by a patient who underwent a hysterectomy. The personal narrative book is intended to support emotional regulation in the preoperative period. The intervention and assessments occur between study inclusion and surgery, which is scheduled 1 to 3 months later. During the study, participants will provide oral informed consent and complete questionnaires to evaluate their emotional and psychological state. Researchers will measure adaptive emotional regulation, anxiety, depression, catastrophizing, the use of supportive measures, and patient satisfaction from inclusion until after surgery. The entire study period includes the preoperative phase up to surgery, with outcomes monitored up to three months following inclusion.

Age: 18Years - 42YearsFEMALEPhase Not Applicable
4 locations
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Actively Recruiting

Researchers are investigating whether using a genetic test called Prosigna4 can help decide if chemotherapy is necessary for premenopausal women with hormone receptor-positive HR and HER2-negative breast cancer. This study aims to determine if treatment guided by this test produces similar outcomes to the standard approach of systematic chemotherapy. The trial focuses on younger women who often experience more side effects from chemotherapy, affecting their quality of life and work capacity. Participants will be randomly assigned to one of two groups. In the experimental group, treatment depends on the Prosigna4 score women with a high score above 60 will receive chemotherapy plus hormone therapy, while those with a lower score will receive only hormone therapy with ovarian suppression. The control group will receive the standard treatment of chemotherapy followed by hormone therapy. The study includes a pre-inclusion period for eligibility testing and randomization. Throughout the study, participants will complete questionnaires about quality of life, treatment side effects, emotional well-being, and other health measures for up to five years after randomization. Researchers will monitor cancer recurrence, survival, fertility, osteoporosis, cardiovascular disease, and other outcomes. Regular assessments include physical activity levels, adherence to therapy, and patient perceptions of treatment and participation, aiming to evaluate the safety and impact of treatment guided by the genetic test.

Age: 35Years - 45YearsFEMALEPhase 3
105 locations
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Actively Recruiting

Researchers are evaluating a remotely supervised online cognitive stimulation program compared to an unsupervised online cognitive exercise program to reduce cognitive complaints in patients treated for localized breast cancer after adjuvant chemotherapy. This study aims to understand if supervision by a neuropsychologist improves the effectiveness of cognitive interventions. Prior studies showed benefits from online programs, and this research explores the added value of personalized support and education during the intervention. The trial includes two groups one receiving a 12-week program with three 20-minute online cognitive sessions weekly plus a 30-minute weekly remote supervision session by a neuropsychologist, and a control group with access to the same online cognitive exercises without supervision. The exercises target up to 12 cognitive areas such as attention, memory, executive functions, and processing speed using the PRESCO program from the HAPPYNeuron-Pro software. Participants will be monitored over 12 weeks, with researchers assessing changes in perceived cognitive impairment using the Functional Assessment of Cancer Therapy-Cognitive Function FACT-Cog questionnaire. The primary outcome is the average change in the Perceived Cognitive Impairment subscale after 12 weeks. The study also evaluates adherence to the program and benefits on objective cognitive impairment. The study is randomized and includes adult female patients who have received chemotherapy and are undergoing radiotherapy.

Age: 18Months +FEMALEPhase Not Applicable
25 locations