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Trial Title:
Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors
NCT ID:
NCT06336538
Condition:
Breast Cancer
Breast Cancer Female
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Mild Depression
Moderate Depression
Conditions: Official terms:
Breast Neoplasms
Depression
Depressive Disorder
Conditions: Keywords:
Black African Americans
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Investigator will first conduct focus groups with older (≥65 years old) African
American/Black (AA/B) breast cancer survivors (BCS) with elevated depressive symptoms.
They will collect participant perspectives on barriers and facilitators to participation
in MBI clinical trials, as well as how to adapt this intervention, called
Mindfulness-Based Cognitive Therapy-Brief (MBCT-Brief), to increase cultural relevancy
for older AA/B BCS with elevated depressive symptoms. They will then conduct a single arm
clinical trial that incorporates the results of the qualitative data analysis to
establish feasibility and acceptability of MBCT-Brief.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
MBCT
Description:
Mindfulness-Based Cognitive Therapy (MBCT) is a group-based psychological intervention
for depression that combines mindfulness training with cognitive therapy.
Arm group label:
Mindfulness-Based Cognitive Therapy
Summary:
The purpose of this research study is to develop and test an intervention designed to
improve mood and reduce symptoms of depression.
Detailed description:
Older African American/Black (AA/B) breast cancer survivors (BCS) experience high rates
of depression and higher cancer-related mortality than non-Hispanic white BCS.Treating
depression in BCS is critical since it is associated with poor health outcomes, in part
due to its detrimental effect on health behaviors and high rate of relapse. Depression is
an independent prognostic factor in BCS and associated with a 25% increased risk of
cancer recurrence, 30% increased risk of all-cause mortality, and 29% increased risk of
cancer-specific mortality. Clinical trials have found that treating depression in a
cohort of women with metastatic breast cancer leads to an increase in survival. However,
recent studies have found that depression is under-treated in participants with cancer,
and despite increases in prescribing practices for antidepressants, rates of depression
are steadily rising. Unfortunately, older adults and AA/Bs are both under-represented in
clinical research and experience health disparities that limit access to evidence-based,
culturally-relevant, depression interventions. In addition, current standard treatment of
depression with anti-depressant medications is associated with poor adherence, side
effects, unpredictable responsiveness, and have drug interactions with antineoplastic and
endocrine therapy medications. Little is known regarding novel, non-pharmacological,
treatments for depression in these populations, and reducing barriers to clinical trial
participation is essential to develop new evidence-based approaches to depression for
older AA BCS. Thus, it is critical to development non-pharmacological approaches for
depression for older AA/B BCS and reduce barriers to clinical trial participation.
Mindfulness-Based Cognitive Therapy (MBCT) is a group-based psychological intervention
for depression that combines mindfulness training with cognitive therapy. MBCT reduces
depressive symptoms in BCS, and the American Society of Clinical Oncology's (ASCO)
guidelines recommend mindfulness-based interventions (MBIs), such as MBCT, for depression
during and after cancer treatment. However, MBCT has significant time and logistical
burden that limits clinical trial participation and clinical implementation due to its 8
weekly 2.5-hour in-person sessions. To address these barriers, investigators developed an
abbreviated MBCT protocol (MBCT-Brief) that is remotely delivered and 8 weekly 1-hour
sessions. However, no studies have adapted MBCT-Brief for the specific needs of older
AA/B BCS (i.e. addressing psychological stressors specific to older AA/B BCS and
including discussion of culturally relevant topics) or tested a culturally-adapted
MBCT-Brief intervention in older AA/B BCS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥65 years old
- fluency in English
- female
- African American/Black
- diagnosis of Stage I, II or III breast cancer
- at least 3 months past active treatment for cancer (chemotherapy, surgery and/or
radiation therapy) with no additional treatment scheduled except endocrine therapy
- mild to moderate symptoms of depression (Patient Health Questionnaire-9(26) scores
4-14)
- willing to be audio and video-recorded
- willing to provide written informed consent.
Exclusion Criteria:
- moderately severe or severe depression (PHQ-9 scores ≥15)
- comorbid psychiatric illness or other psychological disorders that would interfere
with the ability to participate in or receive benefit from MBCT-Brief, including
generalized social anxiety disorder, panic disorder, post-traumatic stress disorder,
obsessive-compulsive disorder, drug abuse or dependence, bipolar disorder,
borderline personality disorder, and active suicidal ideation.
- changes in antidepressant medication within 6 weeks of intake
- prior history of engaging in formal MBIs including Mindfulness-Based Stress
Reduction, MBCT, Acceptance and Commitment Therapy, Dialectical Behavior Therapy
- current daily meditation practice
Gender:
Female
Gender based:
Yes
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cleveland Clinic Department of Wellness and Preventive Medicine
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Contact:
Last name:
Jacob Hill, ND
Start date:
November 1, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06336538