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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Depressive Symptoms
• Intervention / Treatment: Behavioral: Mindfulness Based Intervention; Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Ostacoli, Associate Prof.; Phone Number: 3335613155; Email: luca.ostacoli@unito.it
• Study Contact Backup: Name: Francesca Malandrone, research ass.; Phone Number: 3335613155; Email: francesca.malandrone@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• breast cancer;
• understanding of the Italian language;
• interruption of all psychotropic drugs at least one month before treatment and maintenance of interruption throughout the study or maintenance at baseline level;
• legal capacity to express consent to the processing;
• completion of all treatments except hormone therapy or trastuzumab at least 1 month before;
• score> of 13 and <of 30 at the BDI (Beck Depression Inventory (BDI);
• the ability to use at least e-mail management applications.

Exclusion Criteria:

• presence of serious psychological or psychiatric disorder, (eg severe major depressive disorder, psychotic disorder and bipolar disorder or abuse of active substances);
• severe suicidal tendency;
• presence of overt dementia;
• previous participation in groups of Mindfulness Based Intervention and Cognitive Behavioral Therapy groups.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Intervention; 8 group sessions lasting 2.5 hours each, on a weekly basis.	Behavioral: Mindfulness Based Intervention; The MBI used in this study is called body-affective mindfulness (BAM); BAM is based on: (1) awareness practices such as body scan, breath meditation, walking meditation and yoga exercises; (2) mindfulness in relationship practices such as loving kindness, enriching listening to nature and persons and self-compassion; (3) sensorimotor psychotherapy Sensorimotor psychotherapy emphasizes the use of somatic resources to attain and sustain a mindful disposition and integrates the concept of a stress response with the concept of a "window of tolerance" in order to maximize the clinical utility of the intervention and tailor it to breast cancer patients.; Other Names: MBI; BAM
Active Comparator: Cognitive Behavioral Therapy; 8 group sessions lasting 2.5 hours each, on a weekly basis.	Behavioral: Cognitive Behavioral Therapy; Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.; Other Names: CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in depression symptoms	Beck Depression Inventory (BDI)	week 0, week 8, week 20, week 44
changes in depression and anxiety symptoms	Depression Anxiety Stress Scale	week 0, week 8, week 20, week 44
changes in HRV	Heart Rate Variability evaluation during practice	week 0, week 8, week 20, week 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in brest cancer quality of life	Functional Assessment of Cancer Therapy - Breast (FACT-B)	week 0, week 8, week 20, week 44
changes in fatigue	Additional Concern Subscale of the Functional Assessment of Illness Therapy - Fatigue subscale (FACIT-F)	week 0, week 8, week 20, week 44
changes in self compassion	Self-Compassion Scale-forma breve (SCS-SF)	week 0, week 8, week 20, week 44
changes in sleep quality	Pittsburgh Sleep Quality Index (PSQI)	week 0, week 8, week 20, week 44
changes in attention and self awareness	Mindfulness Awareness Attention Scale (MAAS)	week 0, week 8, week 20, week 44
changes in trauma sypmtoms	Impact of Event Scale - Revised (IES-R)	week 0, week 8, week 20, week 44

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; cognitive behavioral therapy; depressive symptoms; mindfulness based intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Depression; Breast Neoplasms
• Other Study ID Numbers: OstacoliMIND&BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No