NCT03972020

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

Status unknown NA Last updated 2 July 2020

What this trial tests

NA trial testing Mindfulness Based Intervention in Breast Cancer in 100 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
30 September 2022

31 December 2022

Quick facts

Lead sponsor	University of Turin, Italy
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	1 January 2022
Primary completion	30 September 2022
Estimated completion	31 December 2022

Drugs / interventions tested

• Mindfulness Based Intervention
• Cognitive Behavioral Therapy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Depressive Symptoms — all drugs for Depressive Symptoms →

Sponsor

University of Turin, Italy

Who can join

Adults 18 to 70, female only, with Breast Cancer or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.