Breast CancerNCT03972020
Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer
A study testing Mindfulness Based Intervention and Cognitive Behavioral Therapy in people with Breast Cancer and Depressive Symptoms, run by University of Turin, Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Depressive Symptoms
- What is being tested?
- Mindfulness Based Intervention and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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).
Read more
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.
- Conditions
- Breast Cancer, Depressive Symptoms
- Being tested
- Mindfulness Based Intervention, Cognitive Behavioral Therapy
- Keywords
- breast cancer, mindfulness based intervention, cognitive behavioral therapy, depressive symptoms
- Medical subject headings
- Breast Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based InterventionBehavioural
Also called MBI; BAM
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.
Cognitive Behavioral TherapyBehavioural
Also called CBT
Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Intervention | Experimental | 8 group sessions lasting 2.5 hours each, on a weekly basis. Receives: Behavioral: Mindfulness Based Intervention |
| Cognitive Behavioral Therapy | Active comparator | 8 group sessions lasting 2.5 hours each, on a weekly basis. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in depression symptoms
Beck Depression Inventory (BDI)
Measured: week 0, week 8, week 20, week 44
changes in depression and anxiety symptoms
Depression Anxiety Stress Scale
Measured: week 0, week 8, week 20, week 44
changes in HRV
Heart Rate Variability evaluation during practice
Measured: week 0, week 8, week 20, week 44
Secondary outcomes (6)
changes in brest cancer quality of life
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Measured: 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)
Measured: week 0, week 8, week 20, week 44
changes in self compassion
Self-Compassion Scale-forma breve (SCS-SF)
Measured: week 0, week 8, week 20, week 44
changes in sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: week 0, week 8, week 20, week 44
changes in attention and self awareness
Mindfulness Awareness Attention Scale (MAAS)
Measured: week 0, week 8, week 20, week 44
changes in trauma sypmtoms
Impact of Event Scale - Revised (IES-R)
Measured: week 0, week 8, week 20, week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jan 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luca ostacoli, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972020
- Sponsor's protocol ID
- OstacoliMIND&BC
- Status last verified
- Jun 2020
- First submitted
- 11 Feb 2019
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03972020
- Acronym / sponsor ID
- OstacoliMIND&BC
- Conditions
- Breast Cancer, Depressive Symptoms
- Keywords
- breast cancer, mindfulness based intervention, cognitive behavioral therapy, depressive symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Intervention | Experimental | Behavioral: Mindfulness Based Intervention8 group sessions lasting 2.5 hours each, on a weekly basis. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral Therapy8 group sessions lasting 2.5 hours each, on a weekly basis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based InterventionAlso: MBI; BAMThe 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. | Behavioural | Mindfulness Based Intervention |
| Cognitive Behavioral TherapyAlso: CBTCognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
changes in depression symptoms
Time frame: week 0, week 8, week 20, week 44
Beck Depression Inventory (BDI)
changes in depression and anxiety symptoms
Time frame: week 0, week 8, week 20, week 44
Depression Anxiety Stress Scale
changes in HRV
Time frame: week 0, week 8, week 20, week 44
Heart Rate Variability evaluation during practice
6 secondary outcomes
changes in brest cancer quality of life
Time frame: week 0, week 8, week 20, week 44
changes in fatigue
Time frame: week 0, week 8, week 20, week 44
changes in self compassion
Time frame: week 0, week 8, week 20, week 44
changes in sleep quality
Time frame: week 0, week 8, week 20, week 44
changes in attention and self awareness
Time frame: week 0, week 8, week 20, week 44
changes in trauma sypmtoms
Time frame: week 0, week 8, week 20, week 44
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Intervention and Cognitive Behavioral Therapy in people with Breast Cancer and Depressive Symptoms, run by University of Turin, Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Ostacoli, Associate Prof. (3335613155, luca.ostacoli@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in depression symptoms (time frame: week 0, week 8, week 20, week 44). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.