Clinical trial NCT06336538: Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors
Official title: Community Engagement in the Development of an Abbreviated Mindfulness-Based Cognitive Therapy Intervention for Depression in Older African American/Black Breast Cancer Survivors (Community Minds)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Female
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Mild Depression
Moderate Depression
Keywords: Black African Americans
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 31
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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.

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

Primary outcomes:
measure: Mean participant attendance rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Acceptability rate using CSQ(Client Satisfaction Questionnaire-8)
timeFrame: At 8 weeks
Other outcomes:
measure: Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores
timeFrame: Baseline, 8 weeks
measure: Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores
timeFrame: Baseline, 8 weeks
measure: Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores
timeFrame: Baseline, 8 weeks
measure: Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores
timeFrame: Baseline, 8 weeks
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Department of Wellness and Preventive Medicine
state: Ohio
Study officials:
affiliation: Cleveland Clinic Department of Wellness and Preventive Medicine, Cleveland Clinic, Case Comprehensive Cancer Center
name: Jacob Hill, ND
role: PRINCIPAL_INVESTIGATOR
References: