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Spots Global Cancer Trial Database for Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer

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Trial Identification

Brief Title: Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer

Official Title: Mindful-life: a Randomized Clinical Trial to Evaluate the Efficacy of a Mindfulness Based Intervention as Compared to Cognitive Behavioral Therapy for Depressive Symptoms and Quality of Life in Patients With Breast Cancer

Study ID: NCT03972020

Study Description

Brief Summary: Breast cancer is the most common cancer pathology among women worldwide and represents a complex psychological challenge for those affected. Diagnosis and subsequent treatments can have a significant impact not only on the physical well-being of people, but also on their psychological well-being. Tumor-related distress is described as an "unpleasant emotional multifactorial experience of a psychological, social and / or spiritual nature that can interfere with the ability to effectively cope with cancer, physical symptoms and treatment" from the National Comprehensive Cancer Network.Studies have shown that from one third to half of breast cancer patients can experience psychological distress. The psychological distress, understood as symptoms of anxiety, depression and stress, is related to a lower quality of life, a lower compliance related to a lower efficacy of the treatments, a higher mortality and a higher risk of suicide, so much so that this discomfort it is recognized as the sixth vital sign in cancer treatment. Both the diagnosis of cancer and the treatments related to the disease, can lead to the alternation of depressive phases and in some cases even to the presence of major depression: it is estimated that the levels of depression reach thresholds that oscillate between 5 and 25% between women suffering from breast cancer. In reference to what are the interventions aimed at reducing depressive symptomatology in patients with breast cancer, in this study we refer in particular to 2 treatments, of which several studies attest to their effectiveness: interventions based on Mindfulness (MBI) and interventions based on cognitive behavioral therapy (CBT). Cognitive-behavioral therapy (CBT) is an empirically supported treatment for depression. Numerous studies have shown that CBT is both effective in treating acute depression and preventing subsequent relapses and relapses after the end of active treatment. MBI-based interventions have been widely disseminated both at the clinical and research level as short, cost-effective interventions. Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms, sleep, fatigue, disease adaptation and stress reduction, with coping and well-being improved in patients with chronic illnesses including also the oncological pathologies. In particular, a meta-analysis of studies conducted on women with breast cancer confirmed the effectiveness of MBI in reducing symptoms of anxiety, depression and stress, suggesting the importance of these treatments in improving the mental health of these women. In addition, studies have shown that the improvements achieved are stable even at long-term follow-up.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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